Conditions: Cough Healthy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: yes

Brief summary:
This is a phase 1, 2-part, open-label, fixed-sequence study evaluating the effect of rifampin (part 1) and rabeprazole (part 2) on the pharmacokinetics of a single dose of camlipixant (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.

Detailed description:

Arms:
arm 1: Participants will receive a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4. arm 2: Participants will receive a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4

Interventions: intervention 1: Camlipixant intervention 2: Rabeprazole intervention 3: Rifampin
Intervention descriptions: intervention 1: Camlipixant will be administered intervention 2: Rabeprazole will be administered intervention 3: Rifampin will be administered.

Protocol document:
Prot_000.pdf: 
Protocol
Study ID:  221853
Official Title of Study: A PHASE 1, 2-PART, OPEN-LABEL, 
FIXED-SEQUENCE STUDY EVALUATING THE EFFECT OF 
RIFAMPIN (PART 1) AND RABEPRAZOLE (PART 2) ON THE 
PHARMACOKINETICS OF A SINGLE DOSE OF CAMLIPIXANT 
(BLU-5937) 50 mg TABLET IN HEALTHY PARTICIPANTS UNDER 
FASTING CONDITIONS
Date of Document: 20 Jul 2023


The GlaxoSmithKline group of companies 
Clinical Study Report 
Study Protocol Number: 220254 (BUS-P1-11) 
Page 1 of 4 
16.1.1 
Protocol and Protocol Amendments 
Table of contents 
16.1.1 
Protocol and Protocol Amendments ........................................................ 1 
Table of contents ................................................................................................................. 1 
Study Final Protocol 1.0 dated 03-APR-2023 ..................................................................... 2 
Protocol Administrative Letter dated 13-JUN-2023 ......................................................... 70 
Protocol Administrative Letter dated 20-JUL-2023 .......................................................... 73 


The GlaxoSmithKline group of companies 
 
Clinical Study Report 
 
 
Study Protocol Number: 220254 (BUS-P1-11) 
 
 
Page 2 of 4 
 
Study Final Protocol 1.0 dated 03-APR-2023


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PROTOCOL 220254 
Bellus Health study number: BUS-P1-11 
 
A PHASE 1, 2-PART, OPEN-LABEL, FIXED-SEQUENCE STUDY EVALUATING THE 
EFFECT OF RIFAMPIN (PART 1) AND RABEPRAZOLE (PART 2) ON THE 
PHARMACOKINETICS OF A SINGLE DOSE OF CAMLIPIXANT (BLU-5937) 50 mg 
TABLET IN HEALTHY PARTICIPANTS UNDER FASTING CONDITIONS 
 
Sponsor: 
Bellus Health 
275 Armand-Frappier Blvd. 
Laval, Quebec 
Canada, H7V 4A7 
Tel.: 450 680 4500 
 
Contract Research 
Organization: 
Protocol Version: 
Final 
Date: 
03-APR-2023 
CONFIDENTIAL 
 
This document is strictly confidential. It was developed for Bellus Health by 
. The information in this 
document may be disclosed only to persons involved in the study, ethics committees, regulatory agencies and study 
audit personnel. This document is copyrighted in favor of 
 and cannot be reproduced, modified, or 
adapted, in part or in total, without prior written approval by 
. 
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Protocol Historical File 
Version 
Brief description/summary of changes 
Date 
Final 
Version submitted to the Independent Ethics Committee (IEC). 
03-APR-2023 


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Sponsor Signature Page
Bellus Health Cough Inc.
275 Armand-Frappier Blvd.
Laval, Quebec
Canada H7V 4A7
Tel.: (450) 680-4500
s:
______________________
Dr. Denis Garceau, Ph.D.
Date
Chief Scientific Officer
_________________
______________________
Nathalie Chauret, M.Sc.
Date
Executive Director, Head of Drug Development
______
______________________
Sarabjit Gahir, BPharm, Ph.D.
Date
Director of Clinical Pharmacology
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Facilities and Responsible Staff 
Clinical Research Facilities 
This study will be conducted by 
 at the following facility: 
Screening and/or visits may also be performed at the 
 facility: 
Biomedical Laboratory Facilities 
Biomedical laboratory testing will be performed by the following laboratories: 
If another biomedical laboratory is used, this will be documented and annexed to the protocol. 
 
 
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Manager Bioanalysis, Clinical Pharmacology and Bioanalysis 
Institutional Review Board 
Advarra Aurora, Ontario, Canada 
372 Hollandview Trail, Suite 300 
Aurora, Ontario, Canada L4G 0A5 
Tel.: 1-905-727-7989 
 
 
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Table of Contents 
PROTOCOL HISTORICAL FILE ............................................................................................. 2 
SPONSOR SIGNATURE PAGE ................................................................................................. 3 
INVESTIGATOR SIGNATURE PAGE..................................................................................... 4 
FACILITIES AND RESPONSIBLE STAFF ............................................................................. 5 
CLINICAL RESEARCH FACILITIES.................................................................................................................................... 5 
BIOMEDICAL LABORATORY FACILITIES ......................................................................................................................... 5 
CLINICAL PHARMACOLOGY AND BIOANALYSIS ............................................................................................................. 5 
BIOANALYTICAL FACILITY ............................................................................................................................................. 5 
INSTITUTIONAL REVIEW BOARD .................................................................................................................................... 6 
TABLE OF CONTENTS ............................................................................................................. 7 
LIST OF TABLES AND FIGURES ............................................................................................ 9 
LIST OF ABBREVIATIONS .................................................................................................... 10 
SYNOPSIS OF PROTOCOL .................................................................................................... 13 
1. 
INTRODUCTION ............................................................................................................. 26 
1.1 
BACKGROUND INFORMATION............................................................................................................................ 26 
1.2 
NONCLINICAL ................................................................................................................................................... 26 
1.3 
CLINICAL .......................................................................................................................................................... 27 
1.4 
BACKGROUND INFORMATION ON RIFAMPIN ...................................................................................................... 28 
1.5 
BACKGROUND INFORMATION ON RABEPRAZOLE .............................................................................................. 29 
1.6 
STUDY RATIONALE ........................................................................................................................................... 30 
1.7 
BENEFIT/RISK ASSESSMENT .............................................................................................................................. 34 
2. 
OBJECTIVES .................................................................................................................... 35 
3. 
ENDPOINTS ...................................................................................................................... 35 
4. 
STUDY DESIGN ............................................................................................................... 35 
5. 
STUDY POPULATION .................................................................................................... 38 
5.1 
NUMBER OF PARTICIPANTS ............................................................................................................................... 38 
5.2 
INCLUSION CRITERIA ........................................................................................................................................ 38 
5.3 
EXCLUSION CRITERIA ....................................................................................................................................... 39 
5.4 
PARTICIPANT WITHDRAWAL AND REPLACEMENT ............................................................................................. 41 
6. 
STUDY TREATMENTS .................................................................................................. 41 
6.1 
DRUG SUPPLIES AND ACCOUNTABILITY ............................................................................................................ 41 
6.2 
IDENTIFICATION OF TREATMENTS ..................................................................................................................... 42 
6.3 
RANDOMIZATION AND BLINDING ...................................................................................................................... 42 
6.4 
STUDY DRUG ADMINISTRATION ....................................................................................................................... 42 
7. 
STUDY RESTRICTIONS ................................................................................................ 44 
7.1 
CONCOMITANT MEDICATIONS .......................................................................................................................... 44 
7.2 
DRUGS, NICOTINE AND ALCOHOL ..................................................................................................................... 44 
7.3 
DIET .................................................................................................................................................................. 44 
7.4 
POSTURE AND PHYSICAL ACTIVITY .................................................................................................................. 45 
8. 
STUDY PROCEDURES ................................................................................................... 45 
8.1 
PHARMACOKINETIC ASSESSMENTS ................................................................................................................... 46 
8.2 
PHARMACOGENOMIC ASSESSMENTS ................................................................................................................. 47 


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8.3 
SAFETY AND TOLERABILITY ASSESSMENTS ...................................................................................................... 47 
8.4 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ......................................................................................... 50 
8.5 
PREMATURE TERMINATION OF THE STUDY ....................................................................................................... 54 
9. 
STATISTICAL ANALYSES ............................................................................................ 54 
9.1 
ANALYSIS POPULATIONS................................................................................................................................... 54 
9.2 
PHARMACOKINETIC PARAMETERS .................................................................................................................... 55 
9.3 
PHARMACOKINETIC STATISTICAL ANALYSIS .................................................................................................... 56 
9.4 
CRITERIA FOR NO DRUG-DRUG INTERACTION FOR CAMLIPIXANT .................................................................... 56 
9.5 
SAFETY AND TOLERABILITY ANALYSIS ............................................................................................................ 56 
9.6 
PHARMACOGENOMIC EVALUATION ................................................................................................................... 57 
10. 
DATA COLLECTION ...................................................................................................... 57 
11. 
REGULATORY CONSIDERATIONS AND QUALITY ASSURANCE .................... 57 
11.1 
IEC APPROVAL OF PROTOCOL AND OTHER STUDY DOCUMENTS ...................................................................... 57 
11.2 
COMPLIANCE..................................................................................................................................................... 58 
11.3 
QUALITY ASSURANCE AND MONITORING ......................................................................................................... 58 
11.4 
CONFIDENTIALITY AND RETENTION OF STUDY RECORDS ................................................................................. 58 
12. 
REFERENCES .................................................................................................................. 60 
13. 
APPENDIX 1 ..................................................................................................................... 62 
14. 
APPENDIX 2 ..................................................................................................................... 66 
 


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List of Tables and Figures 
TABLE 1. 
SCHEDULE OF ASSESSMENTS FOR PART 1 .................................................................. 20 
TABLE 2. 
SCHEDULE OF ASSESSMENTS FOR PART 2 .................................................................. 23 
FIGURE 1. STUDY DESIGN DIAGRAM FOR PART 1 .......................................................................... 36 
FIGURE 2. STUDY DESIGN DIAGRAM FOR PART 2 .......................................................................... 37 
TABLE 3. 
TIME WINDOWS FOR PK BLOOD SAMPLES FOR PART 1 ............................................. 46 
TABLE 4. 
TIME WINDOWS FOR PK BLOOD SAMPLES FOR PART 2 ............................................. 46 
TABLE 5. 
CLINICAL LABORATORY ASSESSMENTS ..................................................................... 49 
TABLE 6. 
SEVERITY SCALE ....................................................................................................... 51 
TABLE 7. 
RELATIONSHIP CATEGORIES ...................................................................................... 52 


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List of Abbreviations 
AD 
atopic dermatitis 
ADAM 
advanced dissolution, absorption, and metabolism 
AE 
adverse event 
AEMI 
adverse event of medical interest 
ALT 
alanine aminotransferase 
ANOVA 
analysis of variance 
aPTT 
activated partial thromboplastin time 
AST 
aspartate aminotransferase 
ATP 
adenosine triphosphate 
AUC0-inf 
area under the concentration-time curve from time zero to infinity 
(extrapolated) 
AUC0-t 
area under the concentration-time curve from time zero until the last 
observed concentration 
BCRP 
breast cancer resistance protein 
BID 
bis in die (twice a day) 
BMI 
body mass index 
BUN 
blood urea nitrogen 
CDER 
Center for Drug Evaluation and Research 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CK 
creatine kinase 
Cl/F 
apparent clearance 
Cmax 
maximal observed concentration 
COVID-19 
coronavirus 2019 
CRF 
case report form 
CRO 
contract research organization 
CTA 
Clinical Trial Application 
CV 
coefficient of variation 
CYP 
cytochrome P450 
DDI 
drug-drug interaction 
DMP 
data management plan 
DNA 
deoxyribonucleic acid 
eCRF 
electronic case report form 
ECG 
electrocardiogram 
EFD 
embryo-fetal development 


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ET 
early termination 
FDA 
Food and Drug Administration 
FIH 
first-in-human 
fm 
fraction metabolized 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GERD 
gastroesophageal reflux disease 
GGT 
gamma-glutamyl transferase 
GMP 
Good Manufacturing Practice 
HBsAg 
hepatitis B surface antigen 
HCV 
hepatitis C virus 
HEENT 
head, eyes, ears, nose, and throat 
HIV 
human immunodeficiency virus 
IB 
Investigator’s Brochure 
IBS 
irritable bowel syndrome 
ICF 
informed consent form 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IEC 
Independent Ethics Committee 
IME 
important medical event 
INR 
international normalized ratio 
Kel 
terminal elimination rate constant 
LFT 
liver function test 
LS 
least squares 
MAD 
multiple ascending dose 
Max 
maximum 
MDMA 
3,4-methylenedioxymethamphetamine 
MedDRA 
Medical Dictionary for Regulatory Activities 
Min 
minimum 
NERD 
non erosive reflux disease 
NOAEL 
no observed adverse effect level 
NOEL 
no observed effect level 
NOL 
No Objection Letter 
OATP 
organic anion transporter polypeptide 
OTC 
over-the-counter 
PBPK 
physiologically based pharmacokinetic 


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PC 
pharmacokinetic concentration 
PCP 
phencyclidine 
PEPT1 
peptide transporter 1 
PK 
pharmacokinetic(s) 
PPI 
proton-pump inhibitor 
PT 
prothrombin time 
QA 
quality assurance 
QC 
quality control 
QT 
QT interval 
QTcF 
Fridericia’s corrected QT interval 
RBC 
red blood cell 
RCC 
refractory and unexplained chronic cough 
RNA 
ribonucleic acid 
SAD 
single ascending dose 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SAS 
statistical analysis system 
SD 
standard deviation 
SOP 
standard operation procedure 
SUSAR 
suspected, unexpected, serious adverse reaction 
T½ el 
terminal elimination half-life 
TDAE 
taste disturbance adverse event 
TEAE 
treatment-emergent adverse event 
THC 
tetrahydrocannabinol 
Tmax 
time when the maximal concentration is observed 
 
 
ULN 
upper limit of normal 
Vz/F 
apparent volume of distribution 
WBC 
white blood cell 
WHODrug 
World Health Organization Drug 
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Synopsis of Protocol 
Project Number: 
220254 
BUS-P1-11 
Title: 
A Phase 1, 2-Part, Open-label, Fixed-sequence Study Evaluating the Effect 
of Rifampin (Part 1) and Rabeprazole (Part 2) on the Pharmacokinetics of a 
Single Dose of Camlipixant (BLU-5937) 50 mg Tablet in Healthy 
Participants under Fasting Conditions 
Investigational 
Product: 
Camlipixant (BLU-5937) 50 mg Tablet 
Study Phase and Type: 
Phase 1 – Drug-Drug Interaction (DDI) 
Objectives: 
Primary objectives: 
• 
To assess the effect of repeated oral doses of rifampin, a cytochrome 
P450 (CYP) 3A4 and 
 inducer (Part 1), or rabeprazole, a 
proton-pump inhibitor (PPI) (Part 2), on the pharmacokinetics (PK) of a 
single oral dose of camlipixant (BLU-5937), administered to healthy 
participants. 
Secondary objective: 
• 
To evaluate the safety and tolerability of camlipixant when 
administered alone and in combination with rifampin or rabeprazole to 
healthy participants. 
Endpoints: 
Primary endpoints: 
• 
PK parameters: AUC0-inf, AUC0-t, and Cmax 
Secondary endpoints: 
• 
PK parameters: Tmax, T½ el, Residual area, Kel, Cl/F, and Vz/F 
• 
Safety evaluation: 
o Adverse events (AEs), serious adverse events (SAEs), adverse 
events of medical interest (AEMIs), vital signs measurements 
(blood pressure, heart rate, respiratory rate, and oral temperature), 
12-lead electrocardiogram (ECG) recordings, physical 
examinations, and clinical laboratory test results, including 
hematology, biochemistry, coagulation, and urinalysis. 
Study Design: 
This is a single-center, 2-part, Phase 1, open-label, fixed-sequence, DDI 
study designed to compare the PK of camlipixant when administered with 
and without rifampin (Part 1) or rabeprazole (Part 2) in healthy participants 
under fasting conditions. The start of study conduct for Part 2 is 
independent from Part 1 study conduct. 
Participants will be enrolled to either Part 1 or Part 2. In each part, 
participants will receive the assigned treatment. 
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In Part 1, participants will receive a single oral dose of 1 x 50 mg 
camlipixant tablet on Day 1, followed by 48 hours of PK and safety 
assessments. Repeated oral doses of 
 mg rifampin capsules (total 
dose 
mg) will be administered 
 on Days 4 to 12, with 
co-administration of a single oral dose of 1 x 50 mg camlipixant tablet with 
rifampin capsules on Day 11. Administration of camlipixant on Day 11 will 
occur 1 hour (± 2 minutes) after administration of rifampin, followed by 
48 hours of PK and safety assessments. 
In Part 2, participants will receive a single oral dose of 1 x 50 mg 
camlipixant tablet on Day 1, followed by 48 hours of PK and safety 
assessments. Repeated oral doses of 
 mg rabeprazole enteric-coated 
tablets will be administered 
 on Days 4 to 11, with co-administration of 
a single oral dose of 1 x 50 mg camlipixant tablet with rabeprazole 
enteric-coated tablet on Day 10. Administration of camlipixant on Day 10 
will occur 1 hour (± 2 minutes) after administration of rabeprazole, 
followed by 48 hours of PK and safety assessments. 
The study will include a screening visit from Day -28 to Day -1. In each 
part of the study, eligible participants will be admitted to the clinical site on 
Day -1 and will be confined until completion of the assessments on Day 13 
(Part 1) or Day 12 (Part 2). There will be a washout period of at least 3 days 
between the first dose of camlipixant on Day 1 and the first dose of 
rifampin (Part 1) or rabeprazole (Part 2) on Day 4. A follow-up phone call 
will be performed 7 ± 2 days after discharge (Day 20 ± 2 in Part 1 and 
Day 19 ± 2 in Part 2). 
Study Population: 
A total of 32 healthy participants are planned to be enrolled. Participants 
must be ≥ 18 and ≤ 55 years of age and non-smoker for enrollment in the 
study. In Part 1, a total of 16 healthy males and non-childbearing potential 
females will be enrolled. In Part 2, a total of 16 healthy males and females 
will be enrolled. 
Inclusion/Exclusion 
Criteria: 
Inclusion Criteria: 
1. Male (Parts 1 and 2) or non-childbearing potential female (Part 1) or 
female (Part 2), non-smoker (no use of tobacco or nicotine products 
within 3 months prior to screening), ≥18 and ≤55 years of age, with 
BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males and 
≥45.0 kg for females. 
2. Healthy as defined by: 
a. the absence of clinically significant illness and surgery within 
4 weeks prior to dosing. 
b. the absence of clinically significant history of neurological, 
endocrine, cardiovascular, respiratory, hematological, 
immunological, psychiatric, gastrointestinal, renal, hepatic, and 
metabolic disease. 
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3. Female participants of non-childbearing potential (Part 1 and Part 2) 
must be: 
a. post-menopausal (spontaneous amenorrhea for at least 12 months 
prior to dosing) with confirmation by documented FSH levels 
≥40 mIU/mL; or 
b. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, 
or hysterectomy) at least 3 months prior to dosing. 
4. Female participants of childbearing potential (Part 2 only) who are 
sexually active with a non-sterile male partner (sterile male partners are 
defined as men vasectomized for at least 3 months prior to dosing) must 
be willing to use one of the following acceptable contraceptive methods 
throughout the study and for 30 days after the last dose: 
a. simultaneous use of non-hormonal intrauterine device placed at 
least 4 weeks prior to dosing and condom for the male partner; 
b. simultaneous use of diaphragm or cervical cap with spermicide and 
condom for the male partner, started at least 21 days prior to 
dosing; 
c. tubal ligation at least 3 months prior to dosing. 
5. Female participants must be willing not to donate ova for 30 days after 
the last dose. 
6. Male participants who are not vasectomized for at least 3 months prior 
to dosing and who are sexually active with a female partner of 
childbearing potential must be willing to use one of the following 
acceptable contraceptive methods from the first dose and for 90 days 
after the last dose: 
a. simultaneous use of condom and hormonal contraceptive (e.g., oral, 
patch, depot injection, implant, vaginal ring, intrauterine device) or 
non-hormonal intrauterine device used for at least 4 weeks prior to 
sexual intercourse for the female partner; 
b. simultaneous use of condom and a diaphragm or cervical cap with 
spermicide for the female partner. 
7. Male participants (including men who have had a vasectomy) with a 
pregnant partner must agree to use a condom from the first dose and for 
90 days after the last dose. 
8. Male participants must be willing not to donate sperm for 90 days after 
the last dose. 
9. Able to understand the study procedures and provide signed informed 
consent to participate in the study. 
Exclusion Criteria: 
1. Any clinically significant abnormal finding at physical examination at 
screening. 


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2. Clinically significant abnormal laboratory test results or positive 
serology test results for hepatitis B surface antigen (HBsAg), hepatitis 
C virus (HCV) antibody, or human immunodeficiency virus (HIV) 
antigen and antibody, at screening. 
3. Any of the following laboratory parameters above the upper limit of 
normal (ULN) values at screening or baseline (Day -1): aspartate 
aminotransferase (AST), alanine aminotransferase (ALT), direct 
bilirubin, indirect bilirubin, and total bilirubin. Only abnormal values up 
to 1.5x ULN may be repeated once for confirmation to below ULN. 
4. Positive pregnancy test or lactating female participant. 
5. Positive urine drug screen, urine cotinine test, or alcohol breath test. 
6. Positive test for coronavirus 2019 (COVID-19) at admission. 
7. Known allergic reactions or hypersensitivity to camlipixant, rifampin or 
any other rifamycins (participants in Part 1 only), rabeprazole or 
substituted benzimidazoles (participants in Part 2 only), or other related 
drugs, or to any excipient in the formulation. 
8. Clinically significant ECG abnormalities (for example, QTcF > 450 ms) 
or vital signs abnormalities (systolic blood pressure lower than 90 or 
over 140 mmHg, diastolic blood pressure lower than 50 or over 
90 mmHg, or heart rate less than 50 or over 100 bpm) at screening. 
9. History of drug abuse within 1 year prior to screening or recreational 
use of soft drugs (such as medicinal or recreational marijuana) within 
1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, 
opioid derivatives including heroin, and amphetamine derivatives) 
within 3 months prior to screening. 
10. History of alcohol abuse within 1 year prior to screening or regular use 
of alcohol within 6 months prior to screening that exceeds 10 units for 
women or 15 units for men of alcohol per week (1 unit = 340 mL of 
beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%). 
11. History of gastrointestinal disorders, such as stomach ulcers, irritable 
bowel syndrome (IBS), ulcerative or pseudomembranous colitis, 
intestinal obstruction, previous liver disease, hyperbilirubinemia, 
jaundice, or elevated liver enzymes. 
12. Known Gilbert, Rotor, Crigler-Najjar, or Dubin-Johnson syndrome. 
13. Medical history of ageusia/hypogeusia/dysgeusia or known presence of 
a dysfunction in his/her ability to taste. 
14. History of clostridium difficile infection and clostridium 
difficile-associated diseases. 
15. Participants in Part 1 only: History of liver cirrhosis, liver tuberculosis, 
adenocarcinoma of the liver or neoplasm of the biliary tract. 
16. Participants in Part 1 only: History of coagulation disorders. 
17. Participants in Part 2 only: History of osteoporosis. 


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18. Participants in Part 2 only: History of subacute cutaneous lupus 
erythematosus. 
19. Use of medications for the timeframes specified below, with the 
exception of medications exempted by the Investigator on a case-by-
case basis because they are judged unlikely to affect the PK profile of 
the study drug or participant safety (e.g., topical drug products without 
significant systemic absorption): 
a. depot injection or implant within 3 months prior to dosing; 
b. any drug known to induce or inhibit hepatic drug metabolism, 
including St. John’s wort, within 30 days prior to dosing; 
c. prescription medications within 14 days prior to dosing; 
d. any vaccine, including COVID-19 vaccine, within 14 days prior to 
dosing; 
e. over-the-counter (OTC) medications and natural health products 
(including herbal remedies, homeopathic and traditional medicines, 
probiotics, food supplements such as vitamins, minerals, amino 
acids, essential fatty acids, and protein supplements used in sports) 
within 7 days prior to dosing, with the exception of the occasional 
use of acetaminophen (up to 2 g daily). 
20. Participation in a clinical research study involving the administration of 
an investigational or marketed drug or device within 30 days prior to 
dosing, administration of a biological product in the context of a clinical 
research study within 90 days prior to dosing, or concomitant 
participation in an investigational study involving no drug or device 
administration. 
21. Donation of plasma within 7 days prior to dosing or donation or loss of 
500 mL or more of whole blood within 8 weeks prior to dosing. 
22. Any reason which, in the opinion of the Investigator, would prevent the 
participant from participating in the study. 
Study Treatments: 
Participants will receive: 
• 
Camlipixant (BLU-5937) 1 x 50 mg tablet administered under 
fasting conditions 
 on Day 1 (Part 1 and Part 2) and 
Day 11 (Part 1) or Day 10 (Part 2). 
• 
Rifampin 
 mg capsules (total dose 
 mg) administered 
, for 9 consecutive days from Day 4 to Day 12 
in Part 1 only. 
• 
Rabeprazole 
 mg enteric-coated tablet administered 
 
, for 8 consecutive days from Day 4 to Day 11 in Part 2 
only. 
• 
On Day 11 (Part 1) or Day 10 (Part 2), camlipixant will be 
administered 1 hour (± 2 minutes) 
administration of 
rifampin (Part 1) or rabeprazole (Part 2). 
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On Day 1: No food will be allowed from at least 10 hours before 
camlipixant dosing until at least 4 hours after dosing. 
On Day 11 (Part 1) or Day 10 (Part 2): No food will be allowed from at 
least 10 hours before rifampin (Part 1) or rabeprazole (Part 2) dosing until at 
least 4 hours after camlipixant dosing. 
On Days 4 to 10 and Day 12 in Part 1: No food will be allowed from at least 
2 hours before rifampin dosing until 1 hour post-dose. A normo-caloric 
breakfast will be served at least 1 hour after rifampin administration. 
On Days 4 to 9 and Day 11 in Part 2: No food will be allowed from at least 
2 hours before rabeprazole dosing until 1 hour post-dose. A normo-caloric 
breakfast will be served at least 1 hour after rabeprazole administration. 
Study Procedures: 
Blood samples for PK analysis will be collected and safety procedures will 
be performed at pre-defined times throughout the study as specified in 
Table 1. Schedule of Assessments for Part 1 and Table 2. 
Schedule of 
Assessments for Part 2. 
Participants will be monitored throughout the study by the clinical staff for 
AEs and concomitant medication use. 
Statistical Analyses: 
PK analysis: 
Concentrations for rifampin (Part 1) and rabeprazole (Part 2) will be 
tabulated. They will be presented as supportive data. Descriptive statistics 
on pre-dose concentrations of rifampin in Part 1 (Days 9, 10, and 11) and 
rabeprazole in Part 2 (Days 8, 9, and 10) will be performed to evaluate the 
attainment of steady-state. 
 
 
 
 
 
Other possible exploratory markers may be considered as deemed 
necessary. 
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Metabolites of camlipixant may be assayed at a later time, if deemed 
necessary. 
Safety and tolerability analysis: 
Safety and tolerability of camlipixant alone and in combination with 
rifampin (Part 1) or rabeprazole (Part 2) will be evaluated through the 
assessment of AEs, SAEs, AEMIs (i.e., seriousness, severity, relationship to 
the study drug and the interacting drug, outcome, duration, and 
management), vital signs, 12-lead ECGs, clinical laboratory tests, and 
physical examinations. Treatment-emergent adverse events (TEAEs) will be 
tabulated by treatment. Safety and tolerability data will be reported using 
descriptive statistics. 
A Summary Table of study procedures is presented in Appendix 1. 


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Table 1. 
Schedule of Assessments for Part 1 
Study Stage 
Screening 
Baseline 
Treatment 
Follow-up 
phone call 
Day 
-28 to -1 
-1 
1 
2 
3 
4 
5-7 
8-10 
11 
12 
13 
20 ± 2 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographic data 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical and medication history 
X 
 
 
 
 
 
 
 
 
 
 
 
Confinement 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Discharge/ET 
 
 
 
 
 
 
 
 
 
 
X14 
 
Follow-up phone call 
 
 
 
 
 
 
 
 
 
 
 
X15 
Study drug administration 
 
 
 
 
 
 
 
 
 
Camlipixant1 
 
 
X 
 
 
 
 
 
X 
 
 
 
Rifampin2 
 
 
 
 
 
X 
X 
X 
X 
X 
 
 
Pharmacokinetics 
 
 
 
 
 
 
 
 
 
 
 
 
Blood samples for PK analysis of 
Camlipixant3 
 
 
X 
X 
X 
 
 
 
X 
X 
X 
 
Blood samples for PK analysis of rifampin4 
 
 
 
 
 
X 
 
X 
X 
 
 
 
Blood sample for pharmacogenomic 
analysis 
 
X 
 
 
 
 
 
 
 
 
 
 
Safety 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examination5 
X 
X 
 
 
 
 
 
X 
 
 
X 
 
Body measurements (height, weight, BMI) 
X 
 
 
 
 
 
 
 
 
 
 
 
Vital signs6 
X 
 
X 
 
 
 
 
 
X 
 
X 
 
12-lead ECG7 
X 
 
X 
 
 
X 
 
 
X 
 
X 
 
Serology tests8 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical laboratory tests (biochemistry, 
hematology, and coagulation)9 
X 
X 
 
 
 
X 
X 
X 
X 
 
X 
 
Urinalysis10 
X 
X 
 
 
 
X 
 
 
X 
 
X 
 
FSH (for post-menopausal females)11 
X 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy tests12 
X 
X 
 
 
 
 
 
 
 
 
X 
 
Drug, cotinine, and alcohol screens 
X 
X 
 
 
 
 
 
 
 
 
 
 


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Study Stage 
Screening 
Baseline 
Treatment 
Follow-up 
phone call 
Day 
-28 to -1 
-1 
1 
2 
3 
4 
5-7 
8-10 
11 
12 
13 
20 ± 2 
COVID-19 test 
 
X 
 
 
X 
 
 
 
 
 
 
 
Monitoring and recording of AEs, SAEs, 
AEMIs, and prior/concomitant medication 
use13 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE = adverse event; AEMI =adverse event of medical interest; BMI = body mass index; CK = creatine kinase; COVID-19 = coronavirus 2019; 
ECG = electrocardiogram; ET = early termination; FSH = follicle-stimulating hormone; LFT = liver function test; PK = pharmacokinetic; SAE = serious adverse 
event. 
1 
On Day 11, camlipixant will be administered 1 hour (± 2 minutes) 
 administration of rifampin. 
2 
Administration of rifampin will occur at approximately 
 from Days 4 to 12. A time window of ± 10 minutes from the scheduled 
dosing time will be allowed, as long as the 1-hour (± 2 minutes) time interval between rifampin and camlipixant dosing on Day 11 is respected. 
3 
A total of 20 blood samples will be collected for PK analysis of camlipixant on Day 1 and Day 11: at pre-dose and 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 
8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose. Refer to Table 3 for more details. 
4 
A total of 5 blood samples will be collected for PK analysis of rifampin pre-dose on Days 4, 8, 9, 10, and 11. Refer to Table 3 for more details. 
5 
A complete physical examination will be performed at screening. A brief physical examination will be performed on Day -1, in the evening of Day 10, and at 
discharge on Day 13 (or ET). 
6 
Blood pressure, heart rate, respiratory rate, and oral temperature will be measured at screening and discharge on Day 13 (or ET). Blood pressure and heart 
rate will be measured before camlipixant dosing on Day 1 and before rifampin dosing on Day 11. 
7 
12-lead ECG will be measured at screening, before camlipixant dosing on Day 1, before rifampin dosing on Day 4 and Day 11, and at discharge on Day 13 
(or ET). 
8 
Serology tests include hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antigen and 
antibody. 
9 
Standard biochemistry (including LFT and CK), hematology, and coagulation tests will be performed at screening, on Day -1, before rifampin dosing on 
Day 4 and Day 11, and at discharge on Day 13 (or ET). Biochemistry (including LFT and CK) will be also measured before rifampin dosing on Day 6 and 
Day 9. 
10 Urinalysis tests will be performed at screening, on Day -1, before rifampin dosing on Day 4 and Day 11, and at discharge on Day 13 (or ET). 
11 FSH levels will be measured at screening to confirm the post-menopausal status. 
12 A urine pregnancy test will be performed at screening and at discharge on Day 13 (or ET), and a serum pregnancy test will be performed on Day -1. If there 
is a positive pregnancy result following the first study drug administration, a Pregnancy Notification form is to be completed and submitted to the Sponsor. 
13 All AEs, SAEs, and AEMIs will be closely monitored and reported as indicated in safety section 8.4. Following dosing on Day 1 until discharge,  
. Also, 
in the event of 
, a COVID-19 test will be performed. 
14 In case of ET, discharge procedures will be performed as soon as possible. 
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15 A safety follow-up phone call will be performed 7 ± 2 days after discharge. 


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Table 2. 
Schedule of Assessments for Part 2 
Study Stage 
Screening 
Baseline 
Treatment 
Follow-up 
phone call 
Day 
-28 to -1 
-1 
1 
2 
3 
4 
5-6 
7-9 
10 
11 
12 
19 ± 2 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographic data 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical and medication history 
X 
 
 
 
 
 
 
 
 
 
 
 
Confinement 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Discharge/ET 
 
 
 
 
 
 
 
 
 
 
X14 
 
Follow-up phone call 
 
 
 
 
 
 
 
 
 
 
 
X15 
Study drug administration 
 
 
 
 
 
 
 
 
 
 
 
 
Camlipixant1 
 
 
X 
 
 
 
 
 
X 
 
 
 
Rabeprazole2 
 
 
 
 
 
X 
X 
X 
X 
X 
 
 
Pharmacokinetics 
 
 
 
 
 
 
 
 
 
 
 
 
Blood samples for PK analysis of 
camlipixant3 
 
 
X 
X 
X 
 
 
 
X 
X 
X 
 
Blood samples for PK analysis of 
rabeprazole4 
 
 
 
 
 
X 
 
X 
X 
 
 
 
Blood sample for pharmacogenomic 
analysis 
 
X 
 
 
 
 
 
 
 
 
 
 
Safety 
 
 
 
 
 
 
 
 
 
 
 
 
Physical examination5 
X 
X 
 
 
 
 
X 
 
 
X 
 
Body measurements (height, weight, BMI) 
X 
 
 
 
 
 
 
 
 
 
 
 
Vital signs6 
X 
 
X 
 
 
 
 
 
X 
 
X 
 
12-lead ECG7 
X 
 
X 
 
 
X 
 
 
X 
 
X 
 
Serology tests8 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical laboratory tests (biochemistry, 
hematology, and coagulation)9 
X 
X 
 
 
 
X 
 
 
X 
 
X 
 
Urinalysis10 
X 
X 
 
 
 
X 
 
 
X 
 
X 
 
FSH (for post-menopausal females)11 
X 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy tests12 
X 
X 
 
 
 
 
 
 
 
 
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Study Stage 
Screening 
Baseline 
Treatment 
Follow-up 
phone call 
Day 
-28 to -1 
-1 
1 
2 
3 
4 
5-6 
7-9 
10 
11 
12 
19 ± 2 
Drug, cotinine, and alcohol screens 
X 
X 
 
 
 
 
 
 
 
 
 
 
COVID-19 test 
 
X 
 
 
X 
 
 
 
 
 
 
 
Monitoring and recording of AEs, SAEs, 
AEMIs, and prior/concomitant medication 
use13 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE = adverse event; AEMI =adverse event of medical interest; BMI = body mass index; COVID-19 = coronavirus 2019; ECG = 
electrocardiogram; ET = early termination; FSH = follicle-stimulating hormone; LFT = liver function test; PK = pharmacokinetic; SAE = serious adverse event. 
1 
On Day 10, camlipixant will be administered 1 hour (± 2 minutes)
 administration of rabeprazole. 
2 
Administration of rabeprazole will occur at approximately 
 from Days 4 to 11. A time window of ± 10 minutes from the 
scheduled dosing time will be allowed, as long as the 1-hour (± 2 minutes) time interval between rabeprazole and camlipixant dosing on Day 10 is respected. 
3 
A total of 20 blood samples will be collected for PK analysis of camlipixant on Day 1 and Day 10: at pre-dose and 0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 
8, 10, 12, 15, 18, 24, 36, and 48 hours post-dose. Refer to Table 4 for more details. 
4 
A total of 5 blood samples will be collected for PK analysis of rabeprazole pre-dose on Days 4, 7, 8, 9, and 10. Refer to Table 4 for more details. 
5 
A complete physical examination will be performed at screening. A brief physical examination will be performed on Day -1, in the evening of Day 9, and at 
discharge on Day 12 (or ET). 
6 
Blood pressure, heart rate, respiratory rate, and oral temperature will be measured at screening and discharge on Day 12 (or ET). Blood pressure and heart 
rate will be measured before camlipixant dosing on Day 1 and before rabeprazole dosing on Day 10. 
7 
12-lead ECG will be measured at screening, before camlipixant dosing on Day 1, before rabeprazole dosing on Day 4 and Day 10, and at discharge on 
Day 12 (or ET). 
8 
Serology tests include hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antigen and 
antibody. 
9 
Standard biochemistry (including LFT and CK), hematology, and coagulation tests will be performed at screening, on Day -1, before rabeprazole dosing on 
Day 4 and Day 10, and at discharge on Day 12 (or ET). 
10 Urinalysis will be performed at screening, on Day -1, before rabeprazole dosing on Day 4 and Day 10, and at discharge on Day 12 (or ET). 
11 FSH levels will be measured at screening to confirm the post-menopausal status. 
12 A urine pregnancy test will be performed at screening and at discharge on Day 12 (or ET), and a serum pregnancy test will be performed on Day -1. If there 
is a positive pregnancy result following the first study drug administration, a Pregnancy Notification form is to be completed and submitted to the Sponsor. 
13 All AEs, SAEs, and AEMIs will be closely monitored and reported as indicated in safety section 8.4. Following dosing on Day 1 until the end of the study,  
 Also, 
in the event of a 
, a COVID-19 test will be performed. 
14 In case of ET, discharge procedures will be performed as soon as possible. 
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15 A safety follow-up phone call will be performed 7 ± 2 days after discharge. 


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1. 
Introduction 
1.1 
Background Information 
Camlipixant (previously identified as BLU-5937) is a small molecule of the 
 
 that is developed for the treatment of refractory (or unexplained) chronic cough 
(RCC). It has been shown to be a potent, selective, and non-competitive P2X3 homotrimeric 
receptor antagonist. P2X3 receptors are adenosine triphosphate (ATP) cation-gated channels 
located on primary afferent neurons in various tissues, including respiratory tract. ATP released 
from damaged or inflamed tissues acts on P2X3 receptors, triggering pain or irritation signals 
transmitted by sensory afferent fibers to the brain. Specifically, the P2X3 receptor appears to 
play a role in cough hypersensitivity and has been identified as an important target in refractory 
RCC. Camlipixant was shown to reduce significantly cough frequency in patients with baseline 
awake cough frequency 
 coughs/hour in a Phase 2b clinical study.1 
 
2,3 Of note, the high selectivity of camlipixant for the P2X3 homotrimeric receptor versus 
P2X2/3 heterotrimeric receptor should reduce the taste disturbance AEs that have been 
associated to P2X2/3 and observed with other less selective P2X3 antagonists.1 
1.2 
Nonclinical 
The toxicology of camlipixant has been studied in several preclinical species. Selected findings 
are presented below. Please refer to the Investigator’s Brochure (IB) for a complete description 
and summary. Regarding the male reproductive system, camlipixant was shown to have effects 
in the testis with decreased sperm in the epididymis upon long-term administration in animal 
toxicity studies (26 weeks in rat and 39 weeks in dog). These findings were fully reversible and 
were not observed with shorter-term dosing (28 days toxicity study, and a fertility study where 
male rats were administered camlipixant up to 60 days).1 However, it is not known whether the 
effects seen in animals will also occur in men dosed with camlipixant. Since only the long-term 
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preclinical studies have resulted in testicular toxicity and that this has been observed to be 
reversible, it is considered that the risks to healthy male adults receiving single doses, and with a 
suitable washout period between doses, is minimal.  
Lens and corneal opacities have been observed upon chronic 26- and 39-week administration in 
rats and dogs, respectively. These were minor in terms of severity and were considered 
non-adverse as they are not expected to affect the vision. These were not observed with 
short-term dosing and the risks to healthy participants receiving single doses is considered 
minimal.1 
1.3 
Clinical 
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To date, approximately 560 participants have been exposed to camlipixant at doses ranging from 
12.5 mg to 1200 mg as single or multiple BID doses for up to 4 weeks in Phase 1 and Phase 2 
studies. Camlipixant was found to be generally well tolerated in healthy adult participants, 
participants with RCC, and participants with chronic pruritis associated with atopic dermatitis. 
Overall, 210 healthy participants have been exposed to camlipixant at doses ranging from 
12.5 mg to 1200 mg as single or multiple doses in Phase 1 studies. There were no deaths or 
serious adverse events (SAEs) reported during these studies. The most common TEAEs 
(camlipixant/placebo) following administration were headache (10.0% / 3.2%), somnolence 
(9.5% [possibly all related to
 in a DDI study]) / 0.0%), dysgeusia (9.0% / 1.6%), 
constipation (6.2% / 0.0%), dizziness (5.2% / 0.0%), nausea (4.3% / 4.8%), hypoesthesia (3.8% / 
0.0%), diarrhea (3.3% / 0.0%), dyspepsia (2.4% / 1.6%), and abdominal pain (0.0% / 3.2%). 
There were no significant changes in vital signs or ECG parameters at any dose level. There 
were no significant changes in laboratory parameters, except for two isolated cases of mild 
elevations in liver enzymes (alanine aminotransferase [ALT] and/or aspartate aminotransferase 
[AST]), 1 case at 400 mg BID in the FIH and one case at 200 mg BID in a DDI study (BUS-P1-
02). In both cases, these elevations in liver enzymes were not associated with a concomitant 
increase in bilirubin or with clinical symptoms of liver injury. There was a slight trend of 
increased bilirubin in the FIH study (especially at 400 mg BID) and 1 case with 200 mg BID in a 
DDI study (BUS-P1-02; both representing a supra-therapeutic dose), which were not associated 
with any concomitant increases in liver enzymes. The mild elevation in bilirubin in the absence 
of increased liver enzyme levels is likely due to the drug’s interference in bilirubin disposition 
through OATP inhibition and is likely to represent a benign process. Overall, 3 participants were 
discontinued from the Phase 1 clinical studies due to TEAEs, all from the DDI (BUS-P1-02) 
study at the 200 mg BID dose: 2 participants had mild rash (camlipixant) and one of these 
participants had increased AST and ALT levels (sulfasalazine alone).1 
 
 
. 
Refer to the IB v.5 and the IB addendum for detailed background information on camlipixant.1 
1.4 
Background Information on Rifampin 
Rifampin is indicated for the treatment of pulmonary tuberculosis, as well as prophylaxis for 
meningococcal infection. The recommended dosage should not exceed a once daily dose of 
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600 mg for the treatment of tuberculosis and 600 mg twice daily for treatment of meningococcal 
infection. It is recommended that rifampin be administered once daily on an empty stomach 
(1 hour before a meal) to ensure optimum absorption. AEs associated with rifampin are listed in 
the Product Monograph.5  
Rifampin may be bacteriostatic or bactericidal in action, depending on the concentration of the 
drug attained at the site of infection and the susceptibility of the infecting organism. Rifampin 
suppresses initiation of chain formation for ribonucleic acid (RNA) synthesis in susceptible 
bacteria by inhibiting deoxyribonucleic acid (DNA)-depending RNA polymerase.5 
Rifampin is well absorbed from the gastrointestinal tract. Time to peak plasma concentration is 
1.5 to 4 hours after oral administration; peak concentration may be decreased and delayed 
following administration with food. Its elimination half-life is initially 3 to 5 hours; with 
repeated administration half-life decreasing to 2 to 3 hours.5  
Both in the laboratory animal and man, the administration of rifampin has been associated with 
evidence of induction of drug metabolizing enzyme systems of the liver,5 especially the CYP 
family including 
  
1.5 
Background Information on Rabeprazole 
Rabeprazole is a substituted benzimidazole PPI. It is indicated for the treatment of conditions 
where a reduction of gastric acid secretion is required, such as erosive or ulcerative 
gastroesophageal reflux disease (GERD), symptomatic GERD (also known as non-erosive reflux 
disease [NERD]), duodenal and gastric ulcers, and hypersecretory conditions such as 
Zollinger-Ellison syndrome. In combination with antibiotics, it is also used to eradicate 
Helicobacter pylori associated with duodenal ulcer disease. The recommended daily dosage 
ranges from 10 to 60 mg, depending on the disease being treated, with 10 to 20 mg once daily 
being the most frequently recommended dosing regimen. Doses up to 100 mg 
and 60 mg 
twice daily (BID) have been administered as well. AEs associated with rabeprazole are listed in 
the Product Monograph.7  
Rabeprazole sodium is an antisecretory compound that suppresses gastric acid secretion by 
inhibiting the gastric H+, K+- ATPase at the secretory surface of the gastric parietal cell. 
Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole 
has been characterized as a gastric PPI.7 
Following oral administration, rabeprazole is rapidly absorbed and can be detected in plasma as 
early as 0.5 hours. After oral administration of 
mg rabeprazole, peak plasma concentrations 
(Cmax) are reached at an average of 1.6 to 5.0 hours. Bioavailability is 52%. The rabeprazole Cmax 
and AUC are linear with doses from 10 mg to 40 mg. Rabeprazole does not accumulate and its 
PK are not altered by multiple dosing. Rabeprazole is 96.3% bound to human plasma proteins.7 
Taking rabeprazole tablets with food does not alter Cmax or AUC relative to the fasting state; the 
Tmax is increased by 1.7 hours. Administration of rabeprazole with a high fat meal may delay its 
absorption by approximately 4 hours or longer; however, the Cmax and AUC are not altered.7  
The plasma half-life is approximately 1 hour.7  
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1.6 
Study Rationale 
Part 1: 
In vitro studies indicate that 
 play a role in the 
oxidative metabolism of camlipixant.
 
 
1 
Metabolic induction may result in decreased plasma concentrations of drugs and/or their active 
metabolite(s). These decreased plasma concentrations may diminish the therapeutic effects of 
these drugs. 
Therefore, the purpose of Part 1 is to assess, in vivo, the potential of camlipixant to be a victim of 
DDIs precipitated by inducers CYP enzymes (
 believed to be important 
in the biotransformation of camlipixant. In accordance with the recommendations provided in the 
FDA Guidance for Clinical Drug Interaction Studies – Cytochrome P450 Enzyme- and 
Transporter-Mediated Drug Interactions (2020),8 multiple doses of the CYP inducer, rifampin,9 
will be administered to evaluate the effect on the PK of single dose camlipixant. Rifampin was 
judged to be the optimal choice among CYP inducers for this study, given its ability to induce 
both 
 It is a clinically validated, strong inducer for 
 and one of 
the only clinically validated inducers of CYP2C8.9 Additionally, rifampin does not require an 
initial up-titration phase, allowing for an overall shorter exposure time to the perpetrator drug 
and reduces study duration for healthy participants. Therefore, in terms of participant safety, the 
selection of this clinical index inducer represents an advantageous risk mitigation strategy, 
because, with appropriate dosing duration, it allows to achieve sufficient CYP3A induction while 
limiting exposure. Moreover, the use of rifampin to induce both 
 and 
 
represents the worst-case scenario and will enable the Sponsor to validate and refine an existing 
PBPK model and delineate the relative contributions of the two metabolic pathways in clearance 
of camlipixant. Therefore, rifampin is the most optimal inducer to achieve these objectives and 
characterize the DDI profile of camlipixant. 
Part 2: 
Solubility of camlipixant in simulated biological fluids and in buffers at different pH was 
assessed at 37°C.
 
1 Based on the FDA Guidance for Evaluation of Gastric 
pH-Dependent Drug Interactions With Acid-Reducing agents: Study Design, Data Analysis, and 
Clinical Implications (2020), most drugs that have demonstrated pH-dependent DDIs are weak 
bases with low intrinsic aqueous solubility compared to the solubility needed to dissolve the 
clinical dose (i.e., dose divided by 250 mL water).10 In other words, the potential for an 
interaction with pH modifying agents is low when the solubility of a drug is higher than the dose 
divided by 250 mL. 
 
 
 
 
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Accordingly, the purpose of Part 2 is to assess, in vivo, the potential of camlipixant to be a victim 
of DDIs related to reduction in gastric pH. Among acid-reducing agents, PPIs are listed in the 
FDA Guidance for Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing 
agents: Study Design, Data Analysis, and Clinical Implications (2020) as producing long lasting 
effects on gastric pH. In this study, multiple doses of the PPI rabeprazole, mentioned in the 
FDA’s guidance,9 will be administered to evaluate the effect on the PK of single-dose 
camlipixant. Considering that a range of cytochromes (CYPs) are involved in the metabolism of 
camlipixant, rabeprazole is an appropriate choice of PPI as it has a low affinity for a range of 
CYP isoenzymes.11  
1.6.1 
Analytes to Measure 
The analytes to be measured will include the investigational drug camlipixant (Parts 1 and 2), as 
well as rifampin (Part 1) and rabeprazole (Part 2). 
Metabolites of camlipixant may be assayed at a later time, if deemed necessary. 
In this clinical study, rifampin (Part 1) and rabeprazole (Part 2) will be administered in a 
controlled setting i.e., within a clinical research unit with directly observed dosing. Thus, it is not 
relevant to measure extensively rifampin or rabeprazole blood levels. Accordingly, as 
participants will be confined to the clinical unit the full duration of the study, only sparse 
samples for rifampin (Part 1) and rabeprazole (Part 2) will be collected to provide information on 
attainment of steady-state, or to help explain any aberrant results. 
1.6.2 
Rationale for the Dose and Dosing Regimen 
 
 
 
 
 
  
According to the FDA guidance,8 the dose of the perpetrator drug used in DDI studies should 
maximize the possibility of identifying a DDI, by using the maximum approved dose and 
shortest dosing interval. For inducers, such as rifampin, multiple doses are used to ensure the 
maximal induction of a specific pathway. Except for prophylaxis of meningococcal infection, the 
maximal dose and dosing regimen of rifampin in the clinical setting is 
 mg 
.5 According 
to the literature, 
mg was the most commonly used dose in DDI studies using rifampin as a 
perpetrator drug. The duration of rifampin dosing varies between studies. Dosing for 7 days is 
expected to achieve near maximal induction.12 In the interest of not exposing healthy participants 
to more than the minimum required lead-in period of rifampin, and, considering that 7 days of 
dosing is common practice in the literature, co-administration of rifampin with the 
investigational drug will occur on the 8th day of rifampin dosing in this study. This approach has 
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been judged to be sufficient to achieve adequate 
 induction, while minimizing 
unnecessary exposure and safety risks. Following co-administration with camlipixant, rifampin 
will continue to be administered for 1 day, in order to maintain 
 induction during the 
collection period for PK sampling of camlipixant. Therefore, a 
 mg dose of rifampin given 
 as oral capsules for 9 consecutive days, with administration of rifampin 1 hour before 
camlipixant dosing on the 8th day of rifampin administration, has been selected for Part 1. 
Based on the FDA DDI guidance on acid-reducing agents, pre-treatment with PPIs for several 
days (e.g., 4 to 5 days) is needed to reach the pharmacodynamic steady-state of PPIs before 
administering the investigational drug. It is preferable to select a dose that is expected to provide 
a near maximum effect on pH elevation.10 In this study, attainment of maximal effect on pH will 
be ensured by a lead-in period of 6 days with rabeprazole before co-administration of 
camlipixant on the 7th day of rabeprazole dosing. A dose of 
 of rabeprazole represents the 
highest recommended dose for most indications,7 and is in line with the dose listed in the FDA 
guidance.10 The effect of PPIs on gastric pH is long lasting, and thus staggered administration of 
an investigational drug with a PPI is not expected to mitigate the DDI risk.10 A 1-hour time 
interval between rabeprazole and camlipixant dosing will be kept for the day of 
co-administration as standardization with other previously performed DDI studies with 
camlipixant, without minimizing the possible effect on pH. Following co-administration with 
camlipixant, rabeprazole will continue to be administered for 1 day, as a conservative approach. 
Therefore, a 
mg dose of rabeprazole given 
as an oral tablet for 8 consecutive days, with 
administration of rabeprazole 1 hour before camlipixant dosing on the 7th day of rabeprazole 
administration, has been selected for Part 2. 
1.6.3 
Pharmacogenomic Testing 
One blood sample for pharmacogenomic testing will be taken on Day -1.
 
 The sample may be also used to investigate other possible exploratory markers as 
deemed necessary. 
1.6.4 
Rationale for the Study Population 
A healthy volunteer population has been selected for the study because healthy participants with 
no concomitant diseases and using no concomitant medications represent a homogenous 
population allowing for proper evaluation of the PK, safety, and tolerability of a drug without 
confounding factors. 
Embryo-fetal development (EFD) and female and male fertility studies on camlipixant in rats 
and rabbits did not identify any findings of concern for humans, including teratogenicity, at the 
proposed clinical doses (safety margins >20 at the 50 mg single dose proposed in this current 
study). The no observed adverse effect levels (NOAEL) for EFD toxicity in pregnant rats was 
100 mg/kg/day with lower maternal body weights, lower fetal body weights, and increased 
incidence of fetal tail abnormalities and skeletal variations observed at the highest dose tested 
(250 mg/kg/day). No test article-related effects on maternal survival, clinical findings, ovarian 
and uterine parameters or gross macroscopic findings were observed at any camlipixant dose 
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level evaluated. The NOAEL for fertility and reproductive effects and early embryonic 
development in female rats was 150 mg/kg/day due to adverse lower fertility and fecundity 
indices, lower number of implantation sites, and post implantation loss observed at 
450 mg/kg/day. In the EFD study in pregnant rabbits, based upon the maternal clinical signs and 
lower body weight gain and food consumption at 450 mg/kg/day, the NOAEL for maternal 
toxicity was considered to be 200 mg/kg/day while the NOAEL for EFD toxicity is considered to 
be 450 mg/kg/day. In the male fertility study, the no observed effect level (NOEL) for paternal 
toxicity and male mating, fertility, sperm parameters, and reproductive outcome is considered to 
be 450 mg/kg/day.1 There have been no clinical studies of camlipixant conducted in pregnant 
women. 
Rifampin has been demonstrated to cross the placental barrier and is teratogenic in rodents when 
given orally. In rat studies, a greater number of reabsorbed fetuses and a dose-related decrease in 
fetal weights were observed in the group receiving 200 mg/kg. Treatment with 200 mg/kg of 
rifampin caused an incidence of fusion of the palatine bones, two cases of general malformations 
(monstrosity), one case of bone malformation which consisted of bone centers of the sternum 
divided or missing entirely and fusion of vertebral bodies. In rabbits treated with 200 mg/kg 
rifampin, the number of reabsorbed fetuses were higher and the number of live fetuses lower. 
This was a dose-related effect. The progeny of rabbits treated with 200 mg/kg rifampin showed 
evidence of fissure of the second bone of the sternum, along with hydrocephalus. Also in this 
group, an incidence of 11.9% of spina bifida was observed. In mice, doses of 150-200 mg/kg 
caused dose-dependent toxic effects on the embryos and malformations (particularly cleft palate 
and spina bifida) in 5-10% of the pregnant mice. It is recommended that pregnant women with 
tuberculosis be treated for a minimum of 9 months with multi-drug therapy, including rifampin. 
It has rarely caused postnatal hemorrhages in the mother and infant when administered during 
the last few weeks of pregnancy; vitamin K may be indicated. Neonates should be carefully 
observed for evidence of adverse effects.5 While there are no well controlled studies in pregnant 
women, cases of fetal malformation have been reported when used during pregnancy.13 Thus, 
women of childbearing potential will not be recruited into Part 1; only male and 
non-childbearing potential female participants will be included into this part of the study. 
Sexually active non-surgically-sterile male participants with female partners of childbearing 
potential will be required to use a double contraceptive method. 
For rabeprazole, at maternally toxic doses (25 and 50 mg/kg) in the rat EFD study, incomplete 
ossification of the parietal and/or occipital bones was observed. There were no other effects on 
viability, weight or morphology. At maternally toxic doses (30 mg/kg) in the rabbit EFD study, 
decreased fetal weight and delayed ossification of the proximal tibial epiphysis was observed. 
There were no other effects on fetal viability or morphology. Adequate absorption of rabeprazole 
was demonstrated in the rabbit during the organogenesis period. No effects on fetal development, 
parturition, lactation, postnatal growth and offspring development, or offspring reproductive 
performance were observed in this study. The safety of rabeprazole treatment in pregnancy has 
not been established. Rabeprazole tablets should not be administered to pregnant women unless 
the expected benefits outweigh the potential risks to the fetus.7 In light of these data, only male 
and non-pregnant, non-lactating female participants will be included in Part 2. Sexually active 
female participants of childbearing potential and non-surgically-sterile male participants with 
female partners of childbearing potential will be required to use a double contraceptive method. 


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In order to avoid any potential DDIs associated with hormonal contraceptives in this study, 
hormonal methods of contraception will not be allowed for female participants. 
Pregnancy tests will also be performed at different times over the course of the study for female 
participants. Additional pregnancy reporting information is provided in section 8.4.7. 
Additionally, caution in dosage of rifampin is recommended in elderly persons.5 Furthermore, in 
20 healthy elderly participants given a 
 mg rabeprazole dose 
 for seven days, the AUC 
doubled and the Cmax increased by 60% compared to measurements in a parallel younger control 
group. Also, several published observational studies suggest that PPI therapy may be associated 
with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. In the geriatric 
population, benefits of use of PPIs should be weighed against the increased risk of fractures as 
patients in this category may already be at high risk of osteoporosis-related fractures.7 Therefore, 
the population in this study will include healthy individuals between the ages of 18 and 55 years. 
1.7 
Benefit/Risk Assessment 
The inclusion and exclusion criteria have been chosen to select participants who are known to be 
free from any significant illness, history of autoimmune diseases, and from any condition that 
could impact their safety or interfere with meeting the study objectives. The proposed safety 
screening and monitoring assessments are deemed to be sufficient to monitor potential risks of 
camlipixant administration alone and in combination with rifampin or rabeprazole. There is no 
anticipated therapeutic benefit for the healthy participants in this study. 
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2. 
Objectives 
Primary objectives: 
• To assess the effect of repeated oral doses of rifampin, a 
 and 
 inducer 
(Part 1), or rabeprazole, a PPI (Part 2), on the PK of a single oral dose of camlipixant 
(BLU-5937), administered to healthy participants. 
Secondary objective: 
• To evaluate the safety and tolerability of camlipixant when administered alone and in 
combination with rifampin or rabeprazole to healthy participants. 
3. 
Endpoints 
Primary endpoints: 
• PK parameters: AUC0-inf, AUC0-t, and Cmax 
Secondary endpoints: 
• PK parameters: Tmax, T½ el, Residual area, Kel, Cl/F, and Vz/F 
• Safety evaluation: 
o AEs, SAEs, AEMIs, vital signs measurements (blood pressure, heart rate, respiratory 
rate, and oral temperature), 12-lead ECG recordings, physical examinations, and 
clinical laboratory test results, including hematology, biochemistry, coagulation, and 
urinalysis. 
4. 
Study Design 
This is a single-center, 2-part, Phase 1, open-label, fixed-sequence, DDI study designed to 
compare the PK of camlipixant when administered with and without rifampin (Part 1) or 
rabeprazole (Part 2) in healthy participants under fasting conditions. The start of study conduct 
for Part 2 is independent from Part 1 study conduct. 
A total of 32 participants will be enrolled to either Part 1 or Part 2 (16 participants in each part). 
In each part, participants will receive the assigned treatment. 
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In Part 1, participants will receive a single oral dose of 1 x 50 mg camlipixant tablet on Day 1, 
followed by 48 hours of PK and safety assessments. Repeated oral doses of 
 mg rifampin 
capsules (total dose 
mg) will be administered 
 on Days 4 to 12, with co-administration of 
a 
 mg camlipixant tablet with rifampin capsules on Day 11. 
Administration of camlipixant on Day 11 will occur 1 hour (± 2 minutes) after administration of 
rifampin, followed by 48 hours of PK and safety assessments. The study design is presented in 
Figure 1. 
Figure 1. Study Design Diagram for Part 1 
 
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In Part 2, participants will receive a single oral dose of 1 x 50 mg camlipixant tablet on Day 1, 
followed by 48 hours of PK and safety assessments. Repeated oral doses of 
 mg 
rabeprazole enteric-coated tablets will be administered 
 on Days 4 to 11, with 
co-administration of a single oral dose of 1 x 50 mg camlipixant tablet with rabeprazole 
enteric-coated tablet on Day 10. Administration of camlipixant on Day 10 will occur 1 hour 
(± 2 minutes) after administration of rabeprazole, followed by 48 hours of PK and safety 
assessments. The study design is presented in Figure 2. 
Figure 2. Study Design Diagram for Part 2 
 
The study will include a screening visit from Day -28 to Day -1. In each part of the study, 
eligible participants will be admitted to the clinical site on Day -1 and will be confined until 
completion of the assessments on Day 13 (Part 1) or Day 12 (Part 2). There will be a washout 
period of at least 3 days between the first dose of camlipixant on Day 1 and the first dose of 
rifampin (Part 1) or rabeprazole (Part 2) on Day 4. A follow-up phone call will be performed 
7 ± 2 days after discharge (Day 20 ± 2 in Part 1 and Day 19 ± 2 in Part 2). 
Outings may be permitted during confinement. If permitted, outings will be supervised at all 
times by the clinical site staff to ensure compliance with the protocol and will be limited to the 
grounds surrounding the clinic. 
The total duration of study participation for each participant from screening through the 
follow-up phone call is anticipated to be approximately 7 weeks for Part 1 and 7 weeks for 
Part 2. 
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Each study part is intended to dose in one group; if, for any reason, the study is dosed in more 
than one group, all groups will be dosed at the same clinical site and the same protocol 
requirements and procedures will be followed within each group. 
5. 
Study Population 
5.1 
Number of Participants 
It is planned to enroll up to 16 participants in Part 1 and 16 participants in Part 2 for participation 
in this study (total of 32 participants) in order to have at least 12 evaluable participants for PK 
analysis in each part of the study. No formal sample size calculation has been made. Based on 
experience from previous similar studies, a total of 32 participants (16 in each study part) was 
considered sufficient to adequately characterize the PK potential for a clinical DDI. 
5.2 
Inclusion Criteria 
Participants must meet all of the following criteria to be included in the study: 
1. Male (Parts 1 and 2) or non-childbearing potential female (Part 1) or female (Part 2), 
non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 
and ≤55 years of age, with BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males 
and ≥45.0 kg for females. 
2. Healthy as defined by: 
c. the absence of clinically significant illness and surgery within 4 weeks prior to dosing. 
d. the absence of clinically significant history of neurological, endocrine, cardiovascular, 
respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, 
and metabolic disease. 
3. Female participants of non-childbearing potential (Part 1 and Part 2) must be: 
a. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with 
confirmation by documented FSH levels ≥40 mIU/mL; or 
b. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) at 
least 3 months prior to dosing. 
4. Female participants of childbearing potential (Part 2 only) who are sexually active with a 
non-sterile male partner (sterile male partners are defined as men vasectomized for at least 
3 months prior to dosing) must be willing to use one of the following acceptable 
contraceptive methods throughout the study and for 30 days after the last dose: 
a. simultaneous use of non-hormonal intrauterine device placed at least 4 weeks prior to 
dosing and condom for the male partner; 
b. simultaneous use of diaphragm or cervical cap with spermicide and condom for the male 
partner, started at least 21 days prior to dosing; 
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5. Female participants must be willing not to donate ova for 30 days after the last dose. 
6. Male participants who are not vasectomized for at least 3 months prior to dosing and who are 
sexually active with a female partner of childbearing potential must be willing to use one of 
the following acceptable contraceptive methods from the first dose and for 90 days after the 
last dose: 
a. simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot 
injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device 
used for at least 4 weeks prior to sexual intercourse for the female partner; 
b. simultaneous use of condom and a diaphragm or cervical cap with spermicide for the 
female partner. 
7. Male participants (including men who have had a vasectomy) with a pregnant partner must 
agree to use a condom from the first dose and for 90 days after the last dose. 
8. Male participants must be willing not to donate sperm for 90 days after the last dose. 
9. Able to understand the study procedures and provide signed informed consent to participate 
in the study. 
5.3 
Exclusion Criteria 
Participants to whom any of the following applies will be excluded from the study: 
1. Any clinically significant abnormal finding at physical examination at screening. 
2. Clinically significant abnormal laboratory test results or positive serology test results for 
HBsAg, HCV antibody, or HIV antigen and antibody, at screening. 
3. Any of the following laboratory parameters above the ULN values at screening or baseline 
(Day -1): AST, ALT, direct bilirubin, indirect bilirubin, and total bilirubin. Only abnormal 
values up to 1.5x ULN may be repeated once for confirmation to below ULN. 
4. Positive pregnancy test or lactating female participant. 
5. Positive urine drug screen, urine cotinine test, or alcohol breath test. 
6. Positive test for coronavirus 2019 (COVID-19) at admission. 
7. Known allergic reactions or hypersensitivity to camlipixant, rifampin or any other rifamycins 
(participants in Part 1 only), rabeprazole or substituted benzimidazoles (participants in Part 2 
only), or other related drugs, or to any excipient in the formulation. 
8. Clinically significant ECG abnormalities (for example, QTcF > 450 ms) or vital signs 
abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood 
pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at 
screening. 
9. History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such 
as medicinal or recreational marijuana) within 1 month or hard drugs (such as cocaine, 
phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine 
derivatives) within 3 months prior to screening. 


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10. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 
6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol 
per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 
40%). 
11. History of gastrointestinal disorders, such as stomach ulcers, IBS, ulcerative or 
pseudomembranous colitis, intestinal obstruction, previous liver disease, hyperbilirubinemia, 
jaundice, or elevated liver enzymes. 
12. Known Gilbert, Rotor, Crigler-Najjar, or Dubin-Johnson syndrome. 
13. Medical history of ageusia/hypogeusia/dysgeusia or known presence of a dysfunction in 
his/her ability to taste. 
14. History of clostridium difficile infection and clostridium difficile-associated diseases. 
15. Participants in Part 1 only: History of liver cirrhosis, liver tuberculosis, adenocarcinoma of 
the liver or neoplasm of the biliary tract. 
16. Participants in Part 1 only: History of coagulation disorders. 
17. Participants in Part 2 only: History of osteoporosis. 
18. Participants in Part 2 only: History of subacute cutaneous lupus erythematosus. 
19. Use of medications for the timeframes specified below, with the exception of medications 
exempted by the Investigator on a case-by-case basis because they are judged unlikely to 
affect the PK profile of the study drug or participant safety (e.g., topical drug products 
without significant systemic absorption): 
a. depot injection or implant within 3 months prior to dosing; 
b. any drug known to induce or inhibit hepatic drug metabolism, including St. John’s wort, 
within 30 days prior to dosing; 
c. prescription medications within 14 days prior to dosing; 
d. any vaccine, including COVID-19 vaccine, within 14 days prior to dosing; 
e. OTC medications and natural health products (including herbal remedies, homeopathic 
and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino 
acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to 
dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily). 
20. Participation in a clinical research study involving the administration of an investigational or 
marketed drug or device within 30 days prior to dosing, administration of a biological 
product in the context of a clinical research study within 90 days prior to dosing, or 
concomitant participation in an investigational study involving no drug or device 
administration. 
21. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of 
whole blood within 8 weeks prior to dosing. 
22. Any reason which, in the opinion of the Investigator, would prevent the participant from 
participating in the study. 


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5.4 
Participant Withdrawal and Replacement 
Participants will be advised that they are free to withdraw from the study at any time. Over the 
course of the study, the Sponsor and the Investigator or designee may withdraw any participant 
from the study for one of the reasons described below; participant withdrawal will be done in 
accordance with the clinical site’s SOP: 
• Safety reason; 
• Non-compliance with protocol requirements; 
• Significant protocol deviation; 
• Positive pregnancy test, drug screen, cotinine test, or alcohol breath test. 
Participants who withdraw or are withdrawn from the study after dosing will not be replaced. 
However, in the event that the number of drop-outs exceeds initial expectations, participants who 
withdraw or are withdrawn might be replaced at the discretion of the Sponsor. Such replacement 
resulting in dosing more participants than planned in this protocol would be documented in a 
protocol amendment. 
Participants who withdraw or are withdrawn will be asked to remain at the clinic until the 
Investigator or designee agrees that the participant is fine and can be discharged. As soon as 
participant withdrawal is confirmed, blood sampling will be stopped. A PK blood sample may be 
collected at the time of withdrawal if deemed required by the Investigator. Discharge/ET 
procedures will be performed at the time of withdrawal from the study or as soon as possible 
thereafter. 
6. 
Study Treatments 
6.1 
Drug Supplies and Accountability 
It is the responsibility of the Sponsor to ensure that study drug provided for this study are 
manufactured under Good Manufacturing Practice (GMP) and are suitable for human use. The 
Sponsor is responsible to ship a sufficient amount of dosage units to allow the clinical site to 
maintain an appropriate sampling for the study. 
The clinical site will be responsible for sourcing rifampin from the Canadian or US market and 
rabeprazole from the Canadian market. 
The study drugs will be stored at the clinical site pharmacy as per applicable requirements in a 
locked, environmentally-controlled medication room with restricted access. Container(s) will be 
labeled according to applicable regulations. 
Individual doses for each participant will be dispensed at the clinical site pharmacy, as per 
appropriate SOP and according to the fixed-sequence, in appropriate containers indicated with at 
least the project number and the participant number/spare number. 
All study drugs received at the site will be inventoried and accounted for throughout the study 
and the result recorded in the drug accountability record according to the clinical site appropriate 
SOP. 


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6.2 
Identification of Treatments 
Parts 1 and 2: 
 
 
Part 1: 
 mg capsules of rifampin, total dose 
 mg (Sourced from the Canadian 
or US market) administered 
, for 9 consecutive days from 
Day 4 to Day 12 in Part 1 only. 
Part 2: 
 mg of rabeprazole enteric-coated tablet (Sourced from the Canadian 
market) administered 
, for 8 consecutive days from Day 4 to 
Day 11 in Part 2 only. 
6.3 
Randomization and Blinding 
This study will be an open-label study due to the objective nature of the data. Thus, no 
randomization and blinding measures will be applied. Participants will be administered each 
treatment according to the fixed-sequence scheme. 
6.4 
Study Drug Administration 
Part 1: 
On Day 1 and Day 11, camlipixant will be administered to each participant with 240 mL of 
water. On Day 11, camlipixant will be administered 1 hour after administration of rifampin 
dosing, with a time-tolerance window of ± 2 minutes. The time of administration of both 
camlipixant and rifampin will be recorded, and the time interval between the 2 administrations 
must not fall outside of the scheduled acceptable range. 
Rifampin will be administered to each participant as capsules 
 for 
9 consecutive days, from Day 4 to Day 12. The rifampin capsules will be administered to each 
participant with 240 mL of water. In the event that participants cannot swallow all capsules with 
240 mL of water, additional water may be allowed up to a maximum total volume of 400 mL. 
Administration of rifampin will be performed at approximately the same time on Days 4 to 12. A 
time window of ± 10 minutes from the scheduled rifampin dosing time will be allowed, as long 
as the 1-hour (± 2 minutes) time interval between rifampin and camlipixant dosing on Day 11 is 
respected. 
A hand and mouth check will be performed to ensure consumption of the medication. 
On Day 1, no food will be allowed from at least 10 hours before camlipixant dosing until at least 
4 hours post-dose. 
On Day 11, no food will be allowed from at least 10 hours before rifampin dosing until at least 
4 hours after camlipixant dosing. 
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On Days 4 to 10 and Day 12: No food will be allowed from at least 2 hours before rifampin 
dosing until 1 hour post-dose. A normo-caloric breakfast will be served at least 1 hour after 
rifampin administration. 
On Day 1, except for water given with camlipixant, no fluids will be allowed for 1 hour before 
dosing until 1 hour post-dose. On Day 11, except for water given with camlipixant and rifampin 
dosing, no fluids will be allowed for 1 hour before rifampin dosing until 1 hour post-dose of 
camlipixant. On Days 4, 5, 6, 7, 8, 9, 10, and 12, except for water given with rifampin dosing, no 
fluids will be allowed for 1 hour before dosing until 1 hour post-dose. Water will be provided ad 
libitum at all other times. 
Meals will be standardized throughout the study. 
Part 2: 
On Day 1 and Day 10, camlipixant will be administered to each participant with 240 mL of 
water. On Day 10, camlipixant will be administered 1 hour after administration of rabeprazole 
dosing, with a time-tolerance window of ± 2 minutes. The time of administration of both 
camlipixant and rabeprazole will be recorded, and the time interval between the 
2 administrations must not fall outside of the scheduled acceptable range. 
Rabeprazole will be administered to each participant as tablet 
 for 
8 consecutive days, from Day 4 to Day 11. The rabeprazole tablet will be administered to each 
participant with 240 mL of water. Administration of rabeprazole will be performed at 
approximately the same time on Days 4 to 11. A time window of ± 10 minutes from the 
scheduled rabeprazole dosing time will be allowed, as long as the 1-hour (± 2 minutes) time 
interval between rabeprazole and camlipixant dosing on Day 10 is respected. 
A hand and mouth check will be performed to ensure consumption of the medication. 
On Day 1, no food will be allowed from at least 10 hours before camlipixant dosing until at least 
4 hours post-dose. 
On Day 10, no food will be allowed from at least 10 hours before rabeprazole dosing until at 
least 4 hours after camlipixant dosing. 
On Days 4 to 9 and Day 11: No food will be allowed from at least 2 hours before rabeprazole 
dosing until 1 hour post-dose. A normo-caloric breakfast will be served at least 1 hour after 
rabeprazole administration. 
On Day 1, except for water given with the camlipixant, no fluids will be allowed for 1 hour 
before dosing until 1 hour post-dose. On Day 10, except for water given with camlipixant and 
rabeprazole dosing, no fluids will be allowed for 1 hour before rabeprazole dosing until 1 hour 
post-dose of camlipixant. On Days 4, 5, 6, 7, 8, 9, and 11, except for water given with 
rabeprazole dosing, no fluids will be allowed for 1 hour before dosing until 1 hour post-dose. 
Water will be provided ad libitum at all other times. 
Meals will be standardized throughout the study. 
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7. 
Study Restrictions 
7.1 
Concomitant Medications 
Participants will be required to avoid receiving any vaccination (including COVID-19 vaccine) 
and using prescription medications, OTC medications, and natural health products (including 
herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as 
vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) for 
the period of time specified in exclusion criterion no. 19 and throughout the study.  
Hormonal contraception and hormone replacement therapy for female participants will not be 
allowed. 
No concomitant medications will be allowed during the study, with the exception of medications 
required for the medical management of an AE/SAE, and medications exempted by the 
Investigator on a case-by-case basis that are judged unlikely to affect the PK profile of the study 
drug or participant safety (e.g., topical drug products without significant systemic absorption). 
If vaccination is required for any reason, it must first be discussed with and exempted by the 
Investigator on a case-by-case basis to ensure that it does not compromise the PK profile of the 
study drug or the participant safety. 
Medications taken by participants before dosing will be documented as prior medications and 
medications taken by participants after dosing up to follow-up phone call will be documented as 
concomitant medications. Any prior or concomitant medication use, other than the allowed 
medications stated above, will be reviewed and evaluated on a case-by-case basis by the 
Investigator to determine if they affect a participant’s eligibility or continued participation in the 
study, or for potential impact on the study results. 
7.2 
Drugs, Nicotine and Alcohol 
Participants will be required to abstain from: 
• Soft or hard drugs from screening and throughout the study; 
• Any nicotine product from screening and throughout the study; 
• Alcohol-based products from 24 hours prior to admission until after the last PK blood 
sample collection of the study. 
7.3 
Diet 
Participants will be required to abstain from: 
• Food or beverages containing grapefruit, Seville orange, starfruit, pomegranate, 
pineapple, or pomelo from 7 days prior to first dosing until after the last PK blood sample 
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• Food or beverages containing xanthine derivatives or xanthine-related compounds 
(coffee, black/green tea, chocolate) or energy drinks from 48 hours prior to first dosing 
until after the last PK blood sample collection of the study; 
• Food containing poppy seeds from 24 hours prior to admission. 
7.4 
Posture and Physical Activity 
Part 1: 
Participants will be allowed to engage in normal activity but will avoid lying down or sleeping 
for 4 hours after camlipixant administration on Day 1. On Day 11, participants will be allowed to 
engage in normal activity but will avoid lying down or sleeping for 5 hours after rifampin 
administration. On Days 4 to 10 and Day 12, participants will be allowed to engage in normal 
activity but will avoid lying down or sleeping for 4 hours after each rifampin administration. 
Participants will be required to refrain from strenuous exercise at least 3 days before admission 
and throughout the study. 
Part 2: 
Participants will be allowed to engage in normal activity but will avoid lying down or sleeping 
for 4 hours after camlipixant administration on Day 1. On Day 4, participants will be required to 
remain seated or semi-reclined and will avoid lying down or sleeping for 4 hours after 
rabeprazole administration. On Day 10, participants will be required to remain seated or 
semi-reclined and will avoid lying down or sleeping for 5 hours after rabeprazole administration. 
On Days 5 to 9 and Day 11, participants will be allowed to engage in normal activity but will 
avoid lying down or sleeping for 4 hours after each rabeprazole administration. 
Participants will be required to refrain from strenuous exercise at least 3 days before admission 
and throughout the study. 
8. 
Study Procedures 
Participants must provide written informed consent prior to initiation of any study procedures. 
Unless otherwise specified, study procedures will be conducted in accordance with clinical site 
SOPs. From screening through the follow-up phone call, participants will undergo study 
procedures at pre-defined times as specified in Table 1. 
Schedule of Assessments for Part 1 
and Table 2. Schedule of Assessments for Part 2 and as described in sections 8.1, 8.2, and 8.3. 
Every effort will be made to schedule and perform the procedures as close to the nominal time as 
possible, giving considerations to appropriate posture conditions, practical restrictions, and other 
procedures to be performed at the same time point. 
PK blood sample collection will be performed closest to the nominal time. When vital signs 
measurement or ECG recording coincide with a blood collection, they should preferably be 
performed before the blood collection, whenever possible. Sample collections done outside the 


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pre-defined time windows will not be considered as protocol deviations since actual post-dose 
sampling times will be used for PK and statistical analyses. 
8.1 
Pharmacokinetic Assessments 
8.1.1 
Pharmacokinetic Blood Sample Collection and Processing 
Blood samples for PK analysis will be collected via an intravenous catheter or by direct 
venipuncture at the time points indicated in Table 1. Schedule of Assessments for Part 1 and 
Table 2. 
Schedule of Assessments for Part 2. Applicable time windows for PK blood 
samples are defined in the tables below. 
Table 3. 
Time Windows for PK Blood Samples for Part 1 
Day 
Time point (camlipixant) 
Time point (rifampin) 
Time window 
1 and 11 
Pre-dose 
Pre-dose (Day 11) 
Within 30 minutes 
0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 
4, and 6 hours 
- 
±1 minute 
8, 10, 12, 15, and 18 hours 
- 
±3 minutes 
2 and 12 
24 and 36 hours 
- 
±5 minutes 
3 and 13 
48 hours 
- 
±10 minutes 
4, 8, 9, and 10 
Not applicable 
Pre-dose 
Within 30 minutes 
 
Table 4. 
Time Windows for PK Blood Samples for Part 2 
Day 
Time point (camlipixant) 
Time point 
(rabeprazole) 
Time window 
1 and 10 
Pre-dose 
Pre-dose (Day 10) 
Within 30 minutes 
0.16, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 
4, and 6 hours 
- 
±1 minute 
8, 10, 12, 15, and 18 hours 
- 
±3 minutes 
2 and 11 
24 and 36 hours 
- 
±5 minutes 
3 and 12 
48 hours 
- 
±10 minutes 
4, 7, 8, and 9 
Not applicable 
Pre-dose 
Within 30 minutes 
 
The planned volume of blood to be collected for this study, including that collected for eligibility 
and safety purposes, should not exceed 200 mL in Part 1 and 200 mL in Part 2. Additional tests 
or blood draws could be performed, if deemed required by the Investigator or study staff. 
Procedures for collection and processing of PK blood samples will be detailed in a separate 
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Plasma concentrations of the study drug will be determined using a validated analytical method. 
Details of the analytical method will be provided in a separate document. 
8.2 
Pharmacogenomic Assessments 
One blood sample for pharmacogenomic analysis will be collected upon admission on Day -1 in 
both Part 1 and Part 2. 
8.3 
Safety and Tolerability Assessments 
Part 1: 
Participants will be monitored throughout the study by the clinical staff for AEs/SAEs. On 
Day 1, the Investigator or designee will be on site for camlipixant administration and until 
4 hours post-dose. On Day 4, the Investigator or designee will be on site for rifampin 
administration and until 4 hours post-dose. On Day 11, the Investigator or designee will be on 
site for rifampin administration and camlipixant administration and until 4 hours post-dose of 
camlipixant. The Investigator or designee will be available on call for the remainder of the study. 
Part 2: 
Participants will be monitored throughout the study by the clinical staff for AEs/SAEs. On 
Day 1, the Investigator or designee will be on site for camlipixant administration and until 
4 hours post-dose. On Day 4, the Investigator or designee will be on site for rabeprazole 
administration and until 4 hours post-dose. On Day 10, the Investigator or designee will be on 
site for rabeprazole administration and camlipixant administration and until 4 hours post-dose of 
camlipixant. The Investigator or designee will be available on call for the remainder of the study.  
Parts 1 and 2: 
If necessary, the Investigator or designee at the clinical site or a healthcare professional in a 
nearby hospital will administer treatment for any AEs/SAEs. A crash cart or emergency bag 
containing the necessary rescue material and appropriate medications will be available in the 
clinic to allow rapid intervention in case of emergency. 
Safety parameters will be assessed by the Investigator or designee, using the clinical site 
acceptance ranges as suggested guidelines in making the medical assessment. 
For eligibility purposes, abnormal vital signs measurements or clinical laboratory test results 
may be repeated once if an abnormal result is observed at the initial reading. Moreover, 
abnormalities found in the ECG may need to be confirmed by repeated measurements. In the 
event that the participation of a participant in the study is delayed and some screening procedures 
had been performed outside of the prescribed screening window, outdated screening procedures 
can be repeated. 
Safety assessments scheduled during the study will be repeated according to the clinical site 
SOPs or upon request from the Investigator or designee. Any abnormal repeated measurement 
will be evaluated and repeated, if judged necessary. Further action may be taken upon the 
Investigator or designee’s request. 


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8.3.1 
Physical Examination 
Physical examinations will be performed at the times specified in Table 1. Schedule of 
Assessments for Part 1 and Table 2. Schedule of Assessments for Part 2. 
A complete physical examination will include assessments of the following: head, eyes, ears, 
nose, throat (HEENT), neck, chest, lungs, abdomen, musculoskeletal, dermatological, 
cardiovascular/peripheral vascular, and general neurological examination. 
A brief physical examination will include assessments of the following: HEENT, chest, lungs, 
abdomen, dermatological, cardiovascular/peripheral vascular, and areas of note elicited from the 
participant. 
8.3.2 
Body Measurements 
Body measurements will be performed at screening and will include body weight and height 
measurements, as well as BMI calculation. 
8.3.3 
Vital Signs 
Blood pressure, heart rate, respiratory rate, and oral temperature will be measured after the 
participants have been resting for at least 5 minutes in a sitting position at the times specified in 
Table 1. 
Schedule of Assessments for Part 1 and Table 2. 
Schedule of Assessments for 
Part 2. 
8.3.4 
12-lead ECG 
Standard 12-lead ECG will be recorded after the participants have been resting for at least 
5 minutes in a semi-recumbent or supine position at the times specified in Table 1.
 
Schedule of Assessments for Part 1 and Table 2. 
Schedule of Assessments for Part 2.  
8.3.5 
Laboratory Assessments 
Blood and urine samples for clinical laboratory assessments will be collected according to the 
clinical site SOPs at the times specified in Table 1. Schedule of Assessments for Part 1 and 
Table 2. 
Schedule of Assessments for Part 2. The clinical laboratory assessments to be 
performed are listed in the table below. In case of abnormal results, additional testing may be 
conducted at the discretion of the Investigator. 


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Table 5. 
Clinical Laboratory Assessments 
Biochemistry 
Hematology 
Urinalysis 
Albumin 
Alkaline phosphatase 
ALT 
AST 
Calcium 
Chloride 
Creatine kinase 
Creatinine 
GGT 
Glucose 
Phosphorus 
Potassium  
Sodium 
Total, direct and indirect bilirubin1 
Total protein 
Urea (BUN) 
Uric acid 
 
Hematocrit 
Hemoglobin 
Platelet count 
RBC count 
WBC count and differential: 
• 
Basophils 
• 
Eosinophils 
• 
Lymphocytes 
• 
Monocytes 
• 
Neutrophils 
Bilirubin 
Blood (occult) 
Color and appearance 
Glucose 
Ketones 
Leukocyte esterase 
Nitrite 
pH 
Protein 
Specific gravity 
Urobilinogen 
Microscopic examination (in the 
event of abnormal findings) 
Coagulation2 
aPTT 
PT 
INR 
Serology 
Drug, cotinine, and alcohol 
screens 
Hormone panel - females only 
HBsAg 
HCV antibody 
HIV antigen/antibody 
 
Amphetamines/methamphetamines 
Barbiturates 
Benzodiazepines 
Cocaine 
MDMA 
Methadone 
Opiates 
PCP 
THC 
 
Urine cotinine test 
Alcohol breath test 
FSH (post-menopausal females 
only) 
Serum pregnancy test 
Urine pregnancy test 
Abbreviations: ALT = alanine aminotransferase; aPTT = activated partial thromboplastin time; AST = aspartate 
aminotransferase; BUN = blood urea nitrogen; FSH = follicle-stimulating hormone; GGT = gamma-glutamyl 
transferase; HBsAg = hepatitis B surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; 
INR = international normalized ratio; MDMA = 3,4- methylenedioxymethamphetamine; PCP = phencyclidine; PT = 
prothrombin time; RBC = red blood cell; THC = tetrahydrocannabinol; WBC = white blood cell. 
1 
Considering that indirect bilirubin is calculated from total and direct bilirubin values, indirect bilirubin result 
would not be available in case of total or direct bilirubin below the limit of quantification. 
2 
If the coagulation tests results come back normal but the LFTs results are still abnormal after the repeat, the 
coagulation tests may be repeated upon Investigator’s judgement. 


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8.3.6 
Follow-up Phone Call 
A follow-up phone call will be performed at the times specified in Table 1.Schedule of 
Assessments for Part 1 and Table 2. Schedule of Assessments for Part 2, to ensure the ongoing 
wellbeing of participants after discharge. 
8.4 
Adverse Events and Serious Adverse Events 
8.4.1 
Definition of Adverse Event 
An AE is defined as any untoward medical occurrence in a participant who is administered a 
pharmaceutical product and which does not necessarily have a causal relationship with the 
treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal 
laboratory finding, for example), symptom, or disease temporally associated with the use of a 
medicinal (investigational) product, whether or not considered related to the medicinal 
(investigational) product. 
8.4.2 
Definition of Adverse Events of Medical Interest 
AEMIs are AEs of scientific interest specific to the drug class. They are required to be monitored 
closely and reported by the Investigator to the Sponsor promptly, regardless of relationship, 
severity, expectedness, and seriousness.  
AEMIs for this study include the following, but not limited to: 
The incidence of AEMIs of camlipixant alone from Day 1 to Day 4 pre-dose of rifampin (Part 1) 
or rabeprazole (Part 2) will act as a baseline.  
AEMIs appearing following rifampin administration alone from Day 4 to Day 11 pre-dose of 
camlipixant (Part 1) and rabeprazole administration alone from Day 4 to Day 10 pre-dose of 
camlipixant (Part 2) will be accounted for causality based on their onset date/time.  
8.4.3 
Definition of Serious Adverse Event 
A SAE is defined as any untoward medical occurrence that, at any dose: 
• Results in death; 
• Is life-threatening; 
• Requires inpatient hospitalization or prolongation of existing hospitalization; 
• Results in persistent or significant disability/incapacity; 
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• Is a congenital anomaly/birth defect, or; 
• Is otherwise considered to be an important medical event (IME) that may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may 
require intervention to prevent one of the other outcomes listed in the definition above. 
Medical and scientific judgement should be exercised in deciding whether an event should be 
considered as an IME. 
The Sponsor can upgrade an event at any time; downgrade is not permitted at any time.  
If a SAE occurs to a participant on this study, contact the Sponsor personnel listed in 
Section 8.4.6. 
8.4.4 
Assessment of Severity 
The severity will be described and documented using the following definitions: 
Table 6. 
Severity Scale 
Severity 
Description 
Mild 
Awareness of signs and symptoms but are easily tolerated; are of minor irritant type; 
causing no limitations of usual activities. Signs or symptoms may require minor 
action. 
Moderate 
Discomfort severe enough to cause some limitations of usual activities and may 
require action. 
Severe 
Incapacitating with inability to carry out usual activities or significantly affects 
clinical status, and requires specific action and/or medical attention. 
 
8.4.5 
Assessment of Relationship to Study Drug 
Each AE/SAE must be classified based on medical judgment and according to the following 
relationship categories: definite, probable, possible, unlikely, and not related. Causality 
assessments will need to be applied to the study drug and interacting drug the participant has 
been administered. The definitions for the relationship categories are as follows: 


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Table 7. 
Relationship Categories 
Assessment 
Definition 
Definite 
A clinical event, including laboratory test abnormality, occurring in a plausible time 
relationship to drug administration and which cannot be explained by concurrent 
disease or other drugs or chemicals. The response to withdrawal of the drug 
(de-challenge) should be clinically plausible. The event must be definitive 
pharmacologically or phenomenologically using a satisfactory re-challenge (the drug 
is re-administered to determine if the same reaction occurs) procedure if necessary. 
Probable 
A clinical event, including laboratory test abnormality, occurring in a plausible time 
relationship to drug administration and which cannot be explained by concurrent 
disease or other drugs or chemicals. The response to withdrawal of the drug 
(de-challenge) should be clinically plausible. 
Possible 
A clinical event, including laboratory test abnormality, with a reasonable time 
sequence to the drug administration, but which could also be explained by concurrent 
disease or other drugs or chemicals. Information on drug withdrawal may be lacking 
or unclear. 
Unlikely 
A clinical event, including laboratory test abnormality, with a temporal relationship 
to drug administration which makes a causal relationship improbable and in which 
other drugs, chemicals or underlying disease provide plausible explanations. 
Not related 
Any event that does not meet the above criteria; there is sufficient information that 
aetiology of the event is in no relation to the study drug. 
 
8.4.6 
Event Reporting 
All safety events will be recorded and evaluated for their seriousness, severity, and relationship 
to the study drug and the interacting drug. Safety events will be collected and documented 
starting from the time of signing the informed consent form (ICF), throughout the study, and 
until the follow-up phone call.  
After the initial AE/SAE report, the Investigator is required to proactively follow up with each 
participant at all subsequent visits or contact. All events will be followed up until the resolution, 
stabilization, the event is otherwise explained, or the participant refuses to provide additional 
information (documented as lost to follow-up). 
At any point after completion of the study, if a participant experiences an SAE that is considered 
by the Investigator to be either Definite, Probable, or Possible to study drug, this needs to be 
submitted to the Sponsor as described within. 
Safety events will be reported within 24 hours of learning of the event, using the appropriate 
reporting forms (SAE Form or Pregnancy Form). The notification must be directed to: 
 
Drug Safety and Pharmacovigilance 
And to: 
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Blank copies of the forms are included in the study Investigator’s file. It is not acceptable for the 
Investigator to send photocopies of the patient’s medical records to the Sponsor company or its 
representative in lieu of completion of the appropriate AE eCRF page or SAE Report Form. 
However, there may be instances when copies of medical records for certain cases are requested 
by the Sponsor or its representative. In this instance, all participant identifiers will be blinded on 
the copies of the medical records before submission to the Sponsor or its representative.  
If the Investigator does not have all information regarding an SAE, he/she will not wait to 
receive additional information before completing and sending the form. 
Follow-up reports (as many as required) should be completed and faxed/e-mailed following the 
same procedure above. The Investigator should follow the participant with the event until 
resolution or stabilization of the condition. 
The Investigator must keep a copy of all documentation related to the event in the clinical site 
files. 
8.4.6.1 
Suspected Unexpected Serious Adverse Event Reporting to the IEC and 
Regulatory Agency(ies) 
It is the responsibility of the clinical site to report suspected, unexpected, serious adverse 
reactions (SUSARs) to the IEC responsible for the study per their policies. Report of fatal or 
life-threatening SUSARs must be made as soon as possible, but no later than 7 calendar days 
after first knowledge of the event. Report of SUSARs that are neither fatal nor life-threatening 
must be made as soon as possible, but no later than 15 calendar days after first knowledge of the 
event. 
The Sponsor (or representative) is responsible for notifying the regulatory agency(ies) of 
SUSARs observed during the study conduct per their regulations, as soon as possible but no later 
than 7 calendar days after becoming aware of the information when fatal or life-threatening, or 
15 calendar days when neither fatal nor life-threatening. The Sponsor (or representative) is 
responsible to comply with any other applicable regulatory requirement(s) related to the 
reporting of SAE to other regulatory authority(ies). 
8.4.7 
Pregnancy Reporting 
In the event a dosed female participant or the female partner of a dosed male participant (i.e., has 
received at least one dose of the investigational product) becomes pregnant during or up to 
30 days after the last dose, this pregnancy will be reported to the Sponsor (or representative) 
within 24 hours of first knowledge of the event as described in Section 8.4.6. The applicable 
Pregnancy Notification and Outcome forms will be used.  
Any participant who becomes pregnant during the study will be immediately withdrawn. 
Follow-up information regarding the course and outcome of the pregnancy will be documented 
(after obtaining the consent of the female partner) as per site’s SOP.  
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If at any time during the pregnancy or the outcome of the pregnancy, the participant and/or baby 
experiences an AE that meets the criteria of an SAE and/or reportable event, reporting of the 
event to the IEC responsible for the study and/or to applicable regulatory agency(ies) will be 
performed as per site’s SOP and country-specific reporting requirement. 
8.4.8 
Overdose Reporting 
Although unlikely to occur as study drug is administered as a single dose under direct 
supervision, should a participant experience an overdose (with or without an AE/SAE), protocol 
deviation will need to be documented and reported promptly to the Sponsor. 
8.5 
Premature Termination of the Study 
The study may be prematurely terminated by the Investigator following consultation with the 
Sponsor, by the Sponsor or by the regulatory authorities. Following a decision to discontinue the 
trial, the Investigator will promptly inform the active study participants and the IEC responsible 
for this trial, stating the reasons for discontinuation of the study. It is the responsibility of the 
Sponsor (or representative) to report the premature termination of the study to the regulatory 
authority(ies), when required by the applicable regulatory requirement(s). 
9. 
Statistical Analyses 
A complete description of the statistical analyses to be performed on PK as well as safety and 
tolerability data will be presented in a statistical analysis plan (SAP). 
9.1 
Analysis Populations 
9.1.1 
Safety Population 
The safety population is defined as all participants who receive at least one dose of the study 
drug. 
9.1.2 
Pharmacokinetic Concentration Population 
The pharmacokinetic concentration (PC) population for camlipixant will include all participants 
who received at least one dose of camlipixant drug at Day 1 or Day 11 (Part 1)/Day 10 (Part 2) 
and have at least one reportable concentration. 
9.1.3 
Pharmacokinetic Parameter Population 
The PK parameter population will include all participants for whom the Day 1 and Day 11 
(Part 1) or Day 10 (Part 2) PK profiles of the victim drug camlipixant can be adequately 
characterized, specifically, when administered alone and in combination with rifampin (Part 1) or 
rabeprazole (Part 2). 


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Any participant who experienced emesis during the sampling interval will be evaluated on a 
case-by-case basis in order to determine whether the participant will be excluded from the 
descriptive statistics and statistical analysis. 
Here are some aspects to be considered (but not to be limited to) when determining data 
availability for the PK population: inclusion and exclusion criteria, acceptable times for visit 
dates and measurements, compliance with camlipixant treatment, compliance with rifampin 
(Part 1) or rabeprazole (Part 2) treatment impacting camlipixant PK (number of doses received 
equal to 9 [Part 1] or 8 [Part 2]), 1-hour time interval between rifampin and camlipixant dosing 
on Day 11 of Part 1 or 1-hour time interval between rabeprazole and camlipixant dosing on 
Day 10 of Part 2, the nature and quality of the data, withdrawal, and any protocol deviation. The 
final responsibility of deciding which participants are to be included or excluded lies with the 
Investigator and/or the Sponsor. 
9.1.4 
Pharmacogenomic Population 
The pharmacogenomic population is defined as all participants in the safety population who had 
at least one pharmacogenomic measurement data available. 
9.2 
Pharmacokinetic Parameters 
The following PK parameters will be calculated based on the PK population by standard 
non-compartmental methods for camlipixant: 
• AUC0-t: Area under the concentration-time curve from time zero until the last observed 
concentration 
• AUC0-inf: Area under the concentration-time curve from time zero to infinity 
(extrapolated) 
• Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last 
observed concentration to infinity, calculated as [1 – (AUC0-t/AUC0-inf)] x 100 
• Cmax: Maximal observed concentration 
• Tmax: Time when the maximal concentration is observed 
• T½ el: Terminal elimination half-life 
• Kel: Terminal elimination rate constant 
• Cl/F: Apparent clearance 
• Vz/F: Apparent volume of distribution 
The following information will be presented for rifampin (Part 1): pre-dose concentrations on the 
morning of Days 4, 8, 9, 10, and 11. 
The following information will be presented for rabeprazole (Part 2): pre-dose concentrations on 
the morning of Days 4, 7, 8, 9, and 10. 
Additional PK parameters may be calculated. 


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9.3 
Pharmacokinetic Statistical Analysis 
Statistical analysis described in this section will be based on the PK parameter population. 
Individual and mean plasma concentration versus time curves will be presented for both linear 
and semi-log scales. Descriptive statistics (arithmetic and geometric means, standard deviation 
[SD], CV%, minimum [Min], maximum [Max], and median) of the plasma concentrations versus 
time will be presented as well for the PK parameters. 
Concentrations for rifampin (Part 1) and rabeprazole (Part 2) will be tabulated. They will be 
presented as supportive data. Descriptive statistics on pre-dose concentrations of rifampin in 
Part 1 (Days 9, 10, and 11) and rabeprazole in Part 2 (Days 8, 9, and 10) will be performed to 
evaluate the attainment of steady-state. 
Additional PK statistical analysis may be performed. 
A SAP will be prepared after completion of the final protocol and prior to database lock. 
9.4 
Criteria for No Drug-Drug Interaction for Camlipixant 
 
 
 
9.5 
Safety and Tolerability Analysis 
Demographic parameters will be summarized descriptively. 
Safety and tolerability analysis will be performed for all participants in the safety population. No 
inferential statistical analysis of safety data is planned. 
Safety and tolerability of camlipixant alone and in combination with rifampin (Part 1) or 
rabeprazole (Part 2) will be evaluated through the assessment of AEs, SAEs, AEMIs (i.e., 
seriousness, severity, relationship to the study drug and the interacting drug, outcome, duration, 
and management), vital signs, 12-lead ECGs, clinical laboratory tests, and physical 
examinations. AEs will be coded using the latest version of the Medical Dictionary for 
Regulatory Activities (MedDRA). 
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Concomitant medications will be coded using the most current version of World Health 
Organization drug (WHODrug) dictionary available.  
Note that both MedDRA and WHODrug dictionaries are updated twice annually. 
TEAEs will be tabulated by treatment. Changes from baseline values in vital signs, 12-lead 
ECGs, and clinical laboratory tests will be evaluated. Safety and tolerability data will be reported 
using descriptive statistics. 
9.6 
Pharmacogenomic Evaluation 
 Other possible 
exploratory markers may be considered as deemed necessary. 
10. Data Collection 
The source data will be collected mainly on paper as per site SOPs. Source data should be 
attributable, legible, contemporaneous, original, accurate, and complete. Source documents will 
be maintained in order to maintain data integrity. The Investigator and/or the clinical staff have 
the responsibility of ensuring the accuracy, completeness, legibility, and timeliness of the source 
data. 
Source data will be transcribed by the clinical site in the RAVE electronic data capture system 
electronic case report form (eCRF) designed to capture study protocol required data. Vendor data 
will be received electronically and will be reconciled with eCRF data. Details on the data 
management process will be described in a data management plan (DMP). 
11. Regulatory Considerations and Quality Assurance 
11.1 IEC Approval of Protocol and Other Study Documents 
The Investigator(s) agree to provide the IEC with all appropriate documents, including a copy of 
the protocol/amendments, ICFs, advertising text (if any), Investigator’s Brochure (if any), and 
any other written information provided to study participants. The trial will not begin until the 
Investigators have obtained the IEC favourable written approvals for the above-mentioned study 
documents. A properly executed written ICF shall be read, signed, and dated by each participant 
prior to entering the trial or prior to performing any study procedure. The original signed and 
dated ICF will be kept at the clinical site and a copy will be given to the participant. 
In the event that the protocol is amended, the revised protocol must be approved by the IEC prior 
to its implementation, unless the changes involve only logistical or administrative aspects of the 
trial. If a revised ICF is introduced during the study, each participant’s further consent must be 
obtained. The new version of the ICF must be approved by the IEC, prior to subsequently 
obtaining each participant’s consent. 
The Investigator and the Sponsor’s representative must sign the protocol and its amendments (if 
any) before initiating the study. 
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It is the Sponsor’s responsibility to submit the protocol and its amendments (if any), and the 
ICFs to regulatory authorities when necessary. This task has been delegated to the contract 
research organization (CRO). 
11.2 Compliance 
This study will be conducted in compliance with the protocol, GCP ICH E6 (R2), all applicable 
regulations, including the Federal Food, Drug and Cosmetic Act, U.S. applicable Code of 
Federal Regulations (title 21), and any IEC requirements relative to clinical studies. The study 
will also be conducted in compliance with the recommendations laid down in the most recent 
version of the Declaration of Helsinki, with the exception that registration of such Phase 1 trials 
in a publicly accessible database is not mandatory. As required by the Canadian regulatory 
agency, a Clinical Trial Application (CTA) will be submitted before the beginning of the study 
and a No Objection Letter (NOL) must be received prior to dosing. 
11.3 Quality Assurance and Monitoring 
The Sponsor or its designee will perform the quality assurance and quality control activities of 
this study; however, responsibility for the accuracy, completeness, security, and reliability of the 
study data presented to the Sponsor lies with the Investigator generating the data. When 
applicable, quality assurance procedures will be performed according to the site SOPs. 
The study will be monitored according to the Sponsor monitoring plan and SOP to ensure that it 
is conducted and documented properly according to the protocol, GCP, and all applicable 
regulatory requirements. The Sponsor is entitled to access information about the status of the 
study and to review the original documents of the study. 
The Sponsor may arrange audits as part of the implementation of quality assurance to ensure that 
the study is being conducted in compliance with the protocol, SOPs, GCP, and all applicable 
regulatory requirements. In such case, audits will be independent of and separate from the 
routine monitoring and quality control functions. 
11.4 Confidentiality and Retention of Study Records 
This document contains trade secrets and commercial information that is confidential and may 
not be disclosed to third parties. Persons to whom this study protocol is disclosed must be 
informed that all the information herein is confidential and may not be further divulged. These 
restrictions will apply as well to all future communications if deemed privileged or confidential. 
Publication of the study results may only be allowed with written permission from the Sponsor. 
All information on a participant obtained during the conduct of the study will be kept 
confidential. Participants will be identified by an anonymized identifier on all samples and study 
records provided to the Sponsor or designee. In compliance with ICH GCP, the Sponsor’s 
authorized representatives, monitor(s), auditor(s), IEC, and regulatory authority(ies) will be 
granted direct access to the participant’s original trial-related records for verification of clinical 
trial procedures and/or data, without violating the confidentiality of the participant, to the extent 
permitted by the applicable laws and regulations. Consent from the participant for disclosure of 


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such information will be obtained in writing in the ICF. In addition, should a participant require 
medical care or hospitalization during the course of the study, the clinical site may contact the 
treating physician with the participant’s consent, except that consent may not be requested if 
there is an emergency situation. If the results of the study are published, the participant’s identity 
will remain confidential. 
The clinical site will maintain adequate study records for 25 years after completion or 
termination of study. The Sponsor will be notified prior to the destruction of study records. 


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12. References 
1 
BLU-5937. Investigator’s Brochure. Bellus Health Inc. 5th Edition (version dated April 
22nd, 2022) and Addendum Version 5.0 (dated April 19th, 2022). 
2 
Bellus Health Inc. A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults 
With Refractory Chronic Cough (CALM-2). ClinicalTrials.gov identifier: NCT05600777. 
Updated: March 6, 2023. 
https://clinicaltrials.gov/ct2/show/NCT05600777?term=5937&cond=refractory+chronic+
cough&draw=2&rank=3 
3 
Bellus Health Inc. A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults 
With Refractory Chronic Cough (CALM-1). ClinicalTrials.gov identifier: NCT05599191. 
Updated: March 6, 2023. 
https://clinicaltrials.gov/ct2/show/NCT05599191?term=5937&cond=refractory+chronic+
cough&draw=2&rank=2 
4 
A Phase I, Double-Blind, Randomized, Adaptive-designed Study to Assess the 
Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian 
Subjects Following Single and Multiple Oral Doses. BUS-P1-07/C20042. Clinical Study 
Report. Bellus Health. 11 November 2022. 
5 
ROFACT®, Product Monograph. Version revised on June 28, 2019. Drug Product 
Database, Health Canada. Available online at: health-products.canada.ca/dpd-
bdpp/index-eng.jsp 
6 
Rifampin Capsules USP, Drug Label Information. Version revised: April 2022. Available 
online at: dailymed.nlm.nih.gov/dailymed/index.cfm 
7 
PARIET®, Product Monograph. Version revised on August 8, 2022. Drug Product 
Database, Health Canada. Available online at: health-products.canada.ca/dpd-
bdpp/index-eng.jsp 
8 
Center for Drug Evaluation and Research (CDER), FDA. Guidance for Industry: Clinical 
Drug Interaction Studies – Cytochrome P450 Enzyme- and Transporter-Mediated Drug 
Interactions. January 2020. 
9 
Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers. 
Content current as of 08/24/2022. Accessed on: https://www.fda.gov/drugs/drug-
interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-
and-inducers#table4-2. 
10 
Center for Drug Evaluation and Research (CDER), FDA. Evaluation of Gastric 
pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data 
Analysis, and Clinical Implications. November 2020. 
11 
Wedemeyer RS, Blume H. Pharmacokinetic drug interaction profiles of proton pump 
inhibitors: an update. Drug Saf. 2014;37(4):201-211. 
12 
Kapetas AJ, Sorich MJ, Rodrigues AD, Rowland A. Guidance for Rifampin and 
Midazolam Dosing Protocols To Study Intestinal and Hepatic Cytochrome P450 (CYP) 
3A4 Induction and De-induction. AAPS J. 2019;21(5):78. Published 2019 Jun 19. 


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13 
Kalayci T, Erener-Ercan T, Buyukkale G, Cetinkaya M. Limb deformity in a newborn. Is 
rifampicin just an innocent bystander?. Eur Rev Med Pharmacol Sci. 2015;19(3):517-
519. 
 
 
 


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13. Appendix 1 
Summary Table for Part 1 
 
Procedures 
Screening 
• 
Informed consent 
• 
Inclusion/exclusion criteria 
• 
Demographic data 
• 
Medical and medication history 
• 
Complete physical examination 
• 
Body measurements (height, weight, BMI) 
• 
Vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• 
12-lead ECG 
• 
Serology (HBsAg, HCV antibody, and HIV antigen and antibody) 
• 
Biochemistry (including LFT and CK), hematology, coagulation, urinalysis 
• 
Drug, cotinine, and alcohol screens 
• 
Urine pregnancy test 
• 
FSH levels to confirm post-menopausal status 
• 
Monitoring of AE/SAE/AEMI 
D -1 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Start of confinement 
• 
Blood sample for pharmacogenomic analysis 
• 
Brief physical exam 
• 
Biochemistry (including LFT and CK), hematology, coagulation, urinalysis 
• 
Drug, cotinine, and alcohol screens 
• 
COVID-19 test 
• 
Serum pregnancy test 
D1 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
Single dose administration of camlipixant 50 mg tablet 
• 
Blood samples for PK analysis of camlipixant 
• 
Blood pressure and heart rate: before dosing 
• 
12-lead ECG: before dosing 
D2 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
Blood samples for PK analysis of camlipixant 
D3 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
COVID-19 test 
• 
Blood samples for PK analysis of camlipixant 
D4 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose morning administration of capsules of rifampin 
 mg 
 
• 
Blood sample for PK analysis of rifampin 
• 
12-lead ECG: pre-dose of rifampin administration 
• 
Biochemistry (including LFT and CK), hematology, coagulation, and urinalysis: before dosing 
D5 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
dose morning administration of 2 capsules of rifampin 
mg 
 
D6 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose morning administration of capsules of rifampin 
mg 
 
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• 
Biochemistry (including LFT and CK) before dosing 
D7 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose morning administration of capsules of rifampin 
mg 
 
D8 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose morning administration of capsules of rifampin 
 mg 
 
• 
Blood sample for PK analysis of rifampin 
D9 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
Multiple dose morning administration of
capsules of rifampin 
mg 
 
• 
Blood sample for PK analysis of rifampin 
• 
Biochemistry (including LFT and CK) before dosing 
D10 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
Multiple dose morning administration of  capsules of rifampin 
 mg 
 
• 
Blood sample for PK analysis of rifampin 
• 
Brief physical exam in the evening 
D11 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
Multiple dose morning administration of capsules of rifampin 
mg 
 
• 
Single dose administration of camlipixant 50 mg tablet 1 hour (± 2 minutes) after rifampin 
administration 
• 
Blood samples for PK analysis of camlipixant 
• 
Blood sample for PK analysis of rifampin 
• 
Blood pressure and heart rate: before rifampin dosing 
• 
12-lead ECG: before rifampin dosing 
• 
Biochemistry (including LFT and CK), hematology, coagulation and urinalysis before rifampin 
dosing 
D12 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose morning administration of  capsules of rifampin 
mg 
 
• 
Blood samples for PK analysis of camlipixant 
D13 
Discharge or 
ET 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Brief physical exam 
• 
Vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• 
12-lead ECG 
• 
Biochemistry (including LFT and CK), hematology, coagulation, urinalysis 
• 
Urine pregnancy test 
• 
Blood samples for PK analysis of camlipixant 
• 
Discharge 
D20 ± 2 
• 
Follow-up phone call 
• 
Monitoring of AEs/SAEs/AEMIs and concomitant medications 
Abbreviations: AE = adverse event; AEMI = adverse event of medical interest; CK = creatine kinase; COVID-19 = 
coronavirus 2019; ECG = electrocardiogram; ET = early termination; FSH = follicle-stimulating hormone; HBsAg = 
hepatitis B surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; LFT = liver function 
test; PK = pharmacokinetic, 
; SAE = serious adverse event. 
 
 
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Summary Table for Part 2 
 
Procedures 
Screening 
• 
Informed consent 
• 
Inclusion/exclusion criteria 
• 
Demographic data 
• 
Medical and medication history 
• 
Complete physical examination 
• 
Body measurements (height, weight, BMI) 
• 
Vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• 
12-lead ECG 
• 
Serology (HBsAg, HCV antibody, and HIV antigen and antibody) 
• 
Biochemistry (including LFT and CK), hematology, coagulation, urinalysis 
• 
Drug, cotinine, and alcohol screens 
• 
Urine pregnancy test 
• 
FSH levels to confirm post-menopausal status 
• 
Monitoring of AEs/SAEs/AEMIs 
D -1 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Start of confinement 
• 
Blood sample for pharmacogenomic analysis 
• 
Brief physical exam 
• 
Biochemistry (including LFT and CK), hematology, coagulation, urinalysis 
• 
Drug, cotinine, and alcohol screens 
• 
COVID-19 test 
• 
Serum pregnancy test 
D1 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
Single dose administration of camlipixant 50 mg tablet 
• 
Blood samples for PK analysis of camlipixant 
• 
Blood pressure and heart rate: before dosing 
• 
12-lead ECG: before dosing 
D2 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
Blood samples for PK analysis of camlipixant 
D3 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
COVID-19 test 
• 
Blood samples for PK analysis of camlipixant 
D4 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
dose 
 administration of rabeprazole
 mg enteric-coated tabled 
 
• 
Blood sample for PK analysis of rabeprazole 
• 
12-lead ECG: pre-dose 
• 
Biochemistry (including LFT and CK), hematology, coagulation, and urinalysis: before dosing 
D5 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
dose morning administration of rabeprazole 
mg enteric-coated tabled 
 
D6 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose morning administration of rabeprazole 
mg enteric-coated tabled 
 
D7 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
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• 
 dose 
 administration of rabeprazole
 mg enteric-coated tabled 
 
• 
Blood sample for PK analysis of rabeprazole 
D8 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose 
 administration of rabeprazole 
mg enteric-coated tabled 
 
• 
Blood sample for PK analysis of rabeprazole 
D9 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose 
 administration of rabeprazole
 mg enteric-coated tabled 
 
• 
Blood sample for PK analysis of rabeprazole 
• 
Brief physical exam in the evening 
D10 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
dose 
 administration of rabeprazole 
mg enteric-coated tabled 
 
• 
Single dose administration of camlipixant 
mg tablet 1 hour (± 2 minutes) after rabeprazole 
administration 
• 
Blood samples for PK analysis of camlipixant 
• 
Blood sample for PK analysis of rabeprazole 
• 
Blood pressure and heart rate: before rabeprazole dosing 
• 
12-lead ECG: before rabeprazole dosing 
• 
Biochemistry (including LFT and CK), hematology, coagulation and urinalysis before 
rabeprazole dosing 
D11 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Continued confinement 
• 
 dose 
 administration of rabeprazole 
mg enteric-coated tabled 
 
• 
Blood samples for PK analysis of camlipixant 
D12 
Discharge or 
ET 
• 
Monitoring and recording of AEs/SAEs/AEMIs and concomitant medication use 
• 
Blood samples for PK analysis of camlipixant 
• 
Brief physical exam 
• 
Vital signs (blood pressure, heart rate, respiratory rate, and oral temperature) 
• 
12-lead ECG 
• 
Biochemistry (including LFT and CK), hematology, coagulation, urinalysis 
• 
Urine pregnancy test 
• 
Discharge 
D19 ± 2 
• 
Follow-up phone call 
• 
Monitoring of AEs/SAEs/AEMIs and concomitant medications 
Abbreviations: AE = adverse event; AEMI = adverse event of medical interest; CK = creatine kinase; COVID-19 = 
coronavirus 2019; ECG = electrocardiogram; ET = early termination; FSH = follicle-stimulating hormone; HBsAg = 
hepatitis B surface antigen; HCV = hepatitis C virus; HIV = human immunodeficiency virus; LFT = liver function 
test; PK = pharmacokinetic, 
 SAE = serious adverse event. 
 
 
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CCI - This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by third party copyright laws and 
therefore have been excluded.


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The GlaxoSmithKline group of companies 
 
Clinical Study Report 
 
 
Study Protocol Number: 220254 (BUS-P1-11) 
 
 
Page 3 of 4 
 
Protocol Administrative Letter dated 13-JUN-2023 
 
 
 


Protocol Administrative Letter for Early Phase Studies 
 
This document is confidential. 
Controlled Document ID: 2780E.00, Effective Date 29-Jul-2021 
Page 1 of 2 
Filing requirement: TMF 
Project: 220254 (Sponsor code: BUS-P1-11) 
Sponsor: Bellus Health 
CC: Final Protocol dated 03-APR-2023 
Date: 13-JUN-2023 
Study Title: A Phase 1, 2-Part, Open-label, Fixed-sequence Study Evaluating the Effect of 
Rifampin (Part 1) and Rabeprazole (Part 2) on the Pharmacokinetics of a Single Dose of 
Camlipixant (BLU-5937) 50 mg Tablet in Healthy Participants under Fasting Conditions 
  
This Protocol administrative letter intends to bring the following change to the above-mentioned 
final protocol. 
It should be clarified that safety events must be reported 
 responsible 
for pharmacovigilance and case processing, using an additional e-mail address. Therefore, the 
information on pages 52-53, under section 8.4.6 Event Reporting, has been modified as follows: 
From: 
 
Drug Safety and Pharmacovigilance 
 
 
And to: 
 
To: 
 
 
Bellus Health: 
 
Drug Safety and Pharmacovigilance 
 
 
And to: 
 
 
 
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Administrative Letter 
Sponsor: Bellus Health; Protocol No.: 220254 (BUS-P1-11) 
 
 
This document is confidential. 
Controlled Document ID: 2780E.00, Effective Date 29-Jul-2021 
Page 2 of 2 
Filing requirement: TMF 
Created by: 
, Clinical Research Scientist II   
   
Printed Name, Title 
  Signature 
  Date (dd-MMM-
YYYY) 
  
Jun 13, 2023
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The GlaxoSmithKline group of companies 
 
Clinical Study Report 
 
 
Study Protocol Number: 220254 (BUS-P1-11) 
 
 
Page 4 of 4 
 
Protocol Administrative Letter dated 20-JUL-2023 


Protocol Administrative Letter for Early Phase Studies 
This document is confidential. 
Controlled Document ID: 2780E.00, Effective Date 29-Jul-2021 
Page 1 of 1 
Filing requirement: TMF 
Project: 220254 (Sponsor code: BUS-P1-11) 
Sponsor: Bellus Health 
CC: Final Protocol dated 03-APR-2023 
Date: 20-JUL-2023 
Study Title: A Phase 1, 2-Part, Open-label, Fixed-sequence Study Evaluating the Effect of 
Rifampin (Part 1) and Rabeprazole (Part 2) on the Pharmacokinetics of a Single Dose of 
Camlipixant (BLU-5937) 50 mg Tablet in Healthy Participants under Fasting Conditions 
This Protocol administrative letter intends to bring the following change to the above-mentioned 
final protocol.  
On page 50, under section 8.4.2 Definition of Adverse Events of Medical Interest, it is stated that 
adverse events of medical interest (AEMIs) occurring until the end of the study discharge will 
require 
. This may be misinterpreted as the time of discharge 
from the clinic. However, as AEMIs are part of the secondary safety endpoints, they need to be 
reported and documented from camlipixant first dosing until the end of the study (i.e. until the 
follow-up phone call or early termination [if applicable]), just as any other adverse event. 
Therefore, AEMIs occurring up until the end of the study, and not only until discharge from the 
clinic, will require 
.  
The following sentence: 
 
 
 
Should read as: 
 
 
Created by: 
, Senior Clinical Research 
Scientist 
Printed Name, Title 
Signature 
Date (dd-MMM-
YYYY) 
Jul 20, 2023
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SAP_001.pdf: 
Statistical Analysis Plan
Study ID: 221853
Official Title of Study: A PHASE 1, 2-PART, OPEN-LABEL, FIXED-
SEQUENCE STUDY EVALUATING THE EFFECT OF RIFAMPIN (PART 
1) AND RABEPRAZOLE (PART 2) ON THE PHARMACOKINETICS OF 
A SINGLE DOSE OF CAMLIPIXANT (BLU-5937) 50 mg TABLET IN 
HEALTHY PARTICIPANTS UNDER FASTING CONDITIONS
Date of Document: 02-Nov-2023


The GlaxoSmithKline group of companies 
 
Clinical Study Report 
 
 
Study Protocol Number: 220254 (BUS-P1-11) 
 
 
Page 1 of 3 
 
16.1.2 
Reporting and Analysis Plan  
 
 
Table of contents 
16.1.2 
Reporting and Analysis Plan ................................................................... 1 
Table of contents ................................................................................................................. 1 
Statistical Analysis Plan 1.0 dated 04-OCT-2023 ............................................................... 2 
Statistical Analysis Plan (Table/Figure/Listing Shells) Version 1.0  
dated 26-OCT-2023 ............................................................................................... 32 
 


The GlaxoSmithKline group of companies 
 
Clinical Study Report 
 
 
Study Protocol Number: 220254 (BUS-P1-11) 
 
 
Page 2 of 3 
 
Statistical Analysis Plan 1.0 dated 04-OCT-2023


This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
Page 1 of 29 
 
 
Statistical Analysis Plan for Interventional Studies (Early Phase) 
 
 
Sponsor Name: Bellus Health 
 
Protocol Number: 220254 (BUS-P1-11) 
 
Protocol Title: A Phase 1, 2-Part, Open-label, Fixed-sequence Study Evaluating the Effect of 
Rifampin (Part 1) and Rabeprazole (Part 2) on the Pharmacokinetics of a Single Dose of 
Camlipixant (BLU-5937) 50 mg Tablet in Healthy Participants under Fasting Conditions 
 
Protocol Version and Date: Final, 03-Apr-2023 
 
Sponsor Study Number: BUS-P1-11 
 
Authors: 
, Senior Principal Biostatistician 
, Technical Writer 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notice of Confidential and Proprietary Information: 
The information contained in this document is confidential belonging to Bellus Health. Acceptance of this 
document constitutes agreement by the recipient that no information contained herein will be published or 
disclosed without prior written authorization from an official of Bellus Health. However, this document 
may be disclosed to the appropriate Institutional Review Board and ethics committees or duly authorized 
representatives of a national regulatory authority under the condition that they are requested to keep it 
confidential. In the event of an actual or suspected breach of this obligation, Syneos Health should be 
notified promptly. 
 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
Page 2 of 29 
Revision History 
Version 
Date 
(DD-Mmm-YYYY) 
Document Owner 
Revision Summary 
Final 1.0 
04-Oct-2023 
 
Final version 
 
 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
Page 3 of 29 
Approvals 
I confirm that I have reviewed this document and agree with the content. 
Syneos Health Approval 
, 
Senior Principal Biostatistician 
 
 
Name, Title 
Lead Biostatistician  
 Signature 
 
Date 
(DD-Mmm-YYYY) 
, Sr. Biostatistician 
 
 
Name, Title 
Senior Reviewing Biostatistician 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
,  
Senior Pharmacokineticist 
 
 
Name, Title 
Lead Pharmacokineticist 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
, Medical Writer II 
 
 
 
Name, Title 
Lead Medical Writer 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
Bellus Health Approval 
 
, Ph.D., 
,  
Head of Biostatistics 
 
Name, Title 
Sponsor Contact 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
 M.Sc., 
, Early Phase Development, 
Head of Drug Development 
 
 
Name, Title 
Sponsor Contact 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
, BPharm, Ph.D., 
of Clinical Pharmacology 
 
Name, Title 
Sponsor Contact 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
04-Oct-2023
04-Oct-2023
04-Oct-2023
04-Oct-2023
04-Oct-2023
05-Oct-2023
05-Oct-2023
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
Page 4 of 29 
Table of Contents 
Revision History ..............................................................................................................................2 
Approvals .........................................................................................................................................3 
Table of Contents .............................................................................................................................4 
Glossary of Abbreviations ...............................................................................................................6 
1. 
Purpose .....................................................................................................................................8 
1.1 Responsibilities ....................................................................................................................8 
1.2 Timings of Analyses ............................................................................................................8 
2. 
Study Objectives .......................................................................................................................8 
3. 
Study Description .....................................................................................................................9 
3.1 Subject Selection .................................................................................................................9 
3.2 Determination of Sample Size .............................................................................................9 
3.3 Treatment Assignment .........................................................................................................9 
3.4 Randomization and Blinding .............................................................................................10 
3.5 Participant Withdrawal and Replacement .........................................................................10 
4. 
Endpoints ................................................................................................................................10 
5. 
Analysis Populations ..............................................................................................................10 
5.1 Safety Population ...............................................................................................................11 
5.2 Pharmacokinetic Concentration Population ......................................................................11 
5.3 Pharmacokinetic Parameter Population .............................................................................11 
5.4 Pharmacogenomic Population ...........................................................................................11 
6. 
General Aspects for Statistical Analysis .................................................................................11 
6.1 General Methods ................................................................................................................11 
6.2 Summary Statistics: ...........................................................................................................13 
6.3 Key Definitions ..................................................................................................................13 
6.4 Missing Data ......................................................................................................................14 
7. 
Study Population .....................................................................................................................15 
7.1 Subject Disposition ............................................................................................................15 
7.2 Protocol Deviations ...........................................................................................................15 
7.3 Inclusion and Exclusion Criteria .......................................................................................15 
7.4 Demographics and Other Baseline Characteristics ...........................................................15 
7.5 Medical History .................................................................................................................16 
7.6 Medications .......................................................................................................................16 
7.7 Drug, Cotinine, and Alcohol Screens ................................................................................16 
7.8 Pregnancy Screening .........................................................................................................16 
7.9 Additional Screening Tests ................................................................................................16 
8. 
Pharmacokinetic (PK) Analyses .............................................................................................16 
8.1 Data Handling ....................................................................................................................17 
8.1.1 PK Parameters Calculation Rules ...............................................................................17 
8.1.2 Data Presentation Rules ..............................................................................................17 
8.2 Pharmacokinetic (PK) Parameters .....................................................................................17 
8.3 Assessment of Rifampin Effect (Part 1) ............................................................................19 
8.4 Assessment of Rabeprazole Effect (Part 2) .......................................................................19 
8.5 Attainment of Steady State ................................................................................................20 


Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
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9. 
Pharmacogenomic Analyses ...................................................................................................20 
10. 
Safety...................................................................................................................................20 
10.1 Exposure ..........................................................................................................................20 
10.2 Adverse Events (AEs) .....................................................................................................21 
10.3 Laboratory Evaluations ....................................................................................................22 
10.4 Vital Signs .......................................................................................................................22 
10.5 Electrocardiograms (ECGs) .............................................................................................22 
10.6 Physical Examination ......................................................................................................23 
11. 
Changes from Analysis Planned in the Protocol .................................................................23 
12. 
Programming Considerations ..............................................................................................24 
12.1 General Considerations ....................................................................................................24 
12.2 Table, Listing, and Figure Format ...................................................................................24 
12.2.1 General ......................................................................................................................24 
12.2.2 Headers and Footers ..................................................................................................25 
12.2.3 Display Titles ............................................................................................................25 
12.2.4 Column and Row Headings ......................................................................................25 
12.2.5 Body of the Data Display ..........................................................................................25 
12.2.6 Footnotes ...................................................................................................................27 
13. 
Quality Control ...................................................................................................................28 
14. 
Reference List .....................................................................................................................29 
 
 


Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
Page 6 of 29 
Glossary of Abbreviations 
Abbreviation 
Description 
AE 
adverse event 
AEMI 
adverse event of medical interest 
ANOVA 
analysis of variance 
ATC 
anatomical therapeutic chemical 
AUC 
area under the concentration-time curve 
AUC0-inf 
area under the concentration-time curve from time zero to infinity, 
extrapolated 
AUC0-t 
area under the concentration-time curve from time zero until the last 
observed concentration 
BLQ 
below the lower limit of quantification 
BMI 
body mass index 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
Cl/F 
apparent clearance 
Cmax 
maximal observed concentration 
COVID-19 
coronavirus 2019 
CSR 
clinical study report 
CV 
coefficient of variation 
CYP 
cytochrome P450 
DDI 
drug-drug interaction 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
ICH 
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use 
Kel 
terminal elimination rate constant 
Kel Lower 
the timepoint where ln-linear Kel calculation begins 
Kel Upper 
the actual sampling time of the last measurable concentration used 
to estimate the Kel 
LLOQ 
lower limit of quantification 
ln 
natural logarithm 
max 
maximum 
MedDRA® 
Medical Dictionary for Regulatory Activities 


Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
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Abbreviation 
Description 
min 
minimum 
N 
number of subjects 
n 
number of observations 
N/A 
not applicable 
NC 
not calculated 
NR 
no result or not reportable 
NS 
no sample 
PC 
pharmacokinetic concentration 
PK 
pharmacokinetic(s) 
PPI 
proton-pump inhibitor 
PT 
preferred term 
p-value 
probability value 
R2 
R-squared 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SOC 
system organ class 
SOP 
standard operation procedure 
T½ el 
terminal elimination half-life 
TEAE 
treatment-emergent adverse event 
TFLs 
tables, figures, and listings 
Tmax 
time when the maximal concentration is observed 
Vz/F 
apparent volume of distribution 
WHO DD 
World Health Organization Global Drug Dictionary 
 
 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
Page 8 of 29 
1. Purpose 
The purpose of this statistical analysis plan (SAP) is to ensure that the data listings, summary 
tables, and figures which will be produced, and the statistical methodologies that will be used, are 
complete and appropriate to allow valid conclusions regarding the study objectives. 
This SAP is based on the following documents: 
• Protocol 220254 (BUS-P1-11) Final, dated 03-Apr-2023 
• Protocol administrative letters dated 13-Jun-2023 and 20-Jul-2023 
• Electronic case report form (eCRF) version 1.00, dated 11-Jul-2023 
The plan may change due to unforeseen circumstances; any changes made after the plan has been 
finalized will be documented. No revision to the SAP is required for changes which do not affect 
the statistical analysis methods, definitions, or rules defined in this document. If additional 
analyses are required to supplement the planned analyses described in the SAP, the changes and 
justification for the changes will be outlined in the associated clinical study report (CSR). No 
change will be made without prior written approval of the Sponsor.  
When applicable, all methodologies and related processes will be conducted according to Syneos 
Health’s standard operating procedures (SOPs), as appropriate. Shells for all statistical tables, 
listings, and figures referred to in this SAP will be presented in a separate document. 
1.1 
Responsibilities 
Syneos Health will perform the statistical analyses and is responsible for the production and quality 
control of all tables, figures, and listings (TFLs). 
1.2 
Timings of Analyses 
The final safety, tolerability, and pharmacokinetic (PK) analysis will be completed after all 
subjects complete the final study visit or discontinue from the study. 
2. Study Objectives 
• Primary Objectives: 
o To assess the effect of repeated oral doses of rifampin, a cytochrome P450 (CYP) 
3A4 and 
 inducer (Part 1), or rabeprazole, a proton-pump inhibitor (PPI) 
(Part 2), on the PK of a single oral dose of camlipixant (BLU-5937), administered 
to healthy participants. 
• Secondary Objectives: 
o To evaluate the safety and tolerability of camlipixant when administered alone and 
in combination with rifampin or rabeprazole to healthy participants. 
 
 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
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3. Study Description 
This is a single-center, 2-part, Phase 1, open-label, fixed-sequence, drug-drug interaction (DDI) 
study designed to compare the PK of camlipixant when administered with and without rifampin 
(Part 1) or rabeprazole (Part 2) in healthy participants under fasting conditions. The start of study 
conduct for Part 2 is independent from Part 1 study conduct. 
Participants will be enrolled to either Part 1 or Part 2. In each part, participants will receive the 
assigned treatment. 
3.1 
Subject Selection 
A total of 32 healthy, non-smoking participants, ≥18 and ≤55 years of age, with body mass index 
(BMI) >18.5 and <30.0 kg/m2, and body weight ≥50.0 kg for males and ≥45.0 kg for females, are 
planned to be enrolled in this study. In Part 1, a total of 16 healthy males and non-childbearing 
potential females are to be enrolled. In Part 2, a total of 16 healthy males and females are to be 
enrolled. 
3.2 
Determination of Sample Size 
It is planned to enroll up to 16 participants in Part 1 and 16 participants in Part 2 for participation 
in this study (total of 32 participants) in order to have at least 12 evaluable participants for PK 
analysis in each part of the study. No formal sample size calculation has been made. Based on 
experience from previous similar studies, a total of 32 participants (16 in each study part) was 
considered sufficient to adequately characterize the PK potential for a clinical DDI. 
3.3 
Treatment Assignment 
In each study part, subjects will receive the assigned treatment according to the fixed-sequence 
scheme described below. 
In Part 1, subjects will receive a single oral dose of camlipixant on Day 1, followed by a 3-day 
washout period. Repeated oral doses of rifampin will be administered 
) on Days 4 
through 12, with co-administration of a single oral dose of camlipixant with rifampin on Day 11.  
In Part 2, subjects will receive a single oral dose of camlipixant on Day 1, followed by a 3-day 
washout period. 
oral doses of rabeprazole will be administered 
 on Days 4 through 
11, with co-administration of a single oral dose of camlipixant with rabeprazole on Day 10.  
The planned dose levels and regimens are summarized in Table 3.3-1, below. 
Table 3.3-1: Treatment Regimen 
Study Part  Study Day(s) 
Treatment(s) 
Part 1 
Day 1 
1 x 50 mg camlipixant tablet 
Days 4-12 
 mg rifampin capsules (total dose 
mg) 
 
Day 11 
 mg rifampin capsules (total dose 
 mg) 
 and  
1 x 50 mg camlipixant tablet [1 hour (± 2 minutes) after rifampin] 
Part 2 
Day 1 
1 x 50 mg camlipixant tablet 
Days 4-11 
 mg rabeprazole enteric-coated tablets 
 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
Page 10 of 29 
Day 10 
 mg rabeprazole enteric-coated tablets 
and  
1 x 50 mg camlipixant tablet [1 hour (± 2 minutes) after rabeprazole] 
3.4 
Randomization and Blinding 
This study will be an open-label study due to the objective nature of the data. Thus, no 
randomization and blinding measures will be applied. Participants will be administered each 
treatment according to the fixed-sequence scheme. 
3.5 
Participant Withdrawal and Replacement 
Participants will be advised that they are free to withdraw from the study at any time. Over the 
course of the study, the Sponsor and the Investigator or designee may withdraw any participant 
from the study for one of the reasons described below; participant withdrawal will be done in 
accordance with the clinical site’s SOP: 
• Safety reason; 
• Non-compliance with protocol requirements; 
• Significant protocol deviation; 
• Positive pregnancy test, drug screen, cotinine test, or alcohol breath test. 
Participants who withdraw or are withdrawn from the study after dosing will not be replaced. 
However, in the event that the number of drop-outs exceeds initial expectations, participants who 
withdraw or are withdrawn might be replaced at the discretion of the Sponsor. Such replacement 
resulting in dosing more participants than planned in this protocol would be documented in a 
protocol amendment. 
4. Endpoints 
• Primary Endpoints: 
o PK parameters: Area under the concentration-time curve from time zero to infinity, 
extrapolated (AUC0-inf), area under the concentration-time curve from time zero 
until the last observed concentration (AUC0-t), and maximal observed concentration 
(Cmax). 
• Secondary Endpoints: 
o PK parameters: Time when the maximal concentration is observed (Tmax), terminal 
elimination half-life (T½ el), residual area, terminal elimination rate constant (Kel), 
apparent clearance (Cl/F), and apparent volume of distribution (Vz/F). 
o Safety evaluation: Adverse events (AEs), serious AEs (SAEs), AEs of medical 
interest (AEMIs), vital signs measurements (blood pressure, heart rate, respiratory 
rate, and oral temperature), 12-lead electrocardiogram (ECG) recordings, physical 
examinations, and clinical laboratory test results, including hematology, 
biochemistry, coagulation, and urinalysis. 
5. Analysis Populations 
All participants’ inclusion status into each analysis population will be determined after database 
lock and before the final analysis. Participants will be analyzed according to the treatment received. 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
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5.1 
Safety Population 
The safety population is defined as all participants who receive at least one dose of any study drug. 
The safety population will be used for all safety and tolerability summaries and analyses. 
5.2 
Pharmacokinetic Concentration Population 
The pharmacokinetic concentration (PC) population for camlipixant will include all participants 
who received at least one dose of camlipixant at Day 1 or Day 11 (Part 1)/Day 10 (Part 2) and have 
at least one reportable concentration. The PC population will be used for listing of concentrations. 
5.3 
Pharmacokinetic Parameter Population 
The PK parameter population will include all participants for whom the Day 1 and Day 11 (Part 
1) or Day 10 (Part 2) PK profiles of the victim drug, camlipixant, can be adequately characterized, 
specifically, when administered alone and in combination with rifampin (Part 1) or rabeprazole 
(Part 2). The PK parameters population will be used for all PK parameter summaries and analyses. 
Any participant who experienced emesis during the sampling interval will be evaluated on a case-
by-case basis in order to determine whether the participant will be excluded from the descriptive 
statistics and statistical analyses. Individual PK parameters from participant excluded from the PK 
parameter population will be presented in the listing but will be excluded from the descriptive 
statistics and statistical analyses. 
 
Here are some aspects to be considered (but not to be limited to) when determining data availability 
for the PK population: inclusion and exclusion criteria, acceptable times for study days/timepoints 
and measurements, compliance with camlipixant treatment, compliance with rifampin (Part 1) or 
rabeprazole (Part 2) treatment impacting camlipixant PK (number of doses received equal to 9 
[Part 1] or 8 [Part 2]), 1-hour time interval between rifampin and camlipixant dosing on Day 11 of 
Part 1 or 1-hour time interval between rabeprazole and camlipixant dosing on Day 10 of Part 2, 
the nature and quality of the data, withdrawal, and any protocol deviation. The final responsibility 
of deciding which participants are to be included or excluded lies with the Investigator and/or the 
Sponsor. 
5.4 
Pharmacogenomic Population 
The pharmacogenomic population will include all participants in the safety population who had at 
least one pharmacogenomic measurement data available. 
6. General Aspects for Statistical Analysis 
6.1 
General Methods 
software release 9.4 (or more recent version) will be used to perform all 
statistical analyses. All relevant data in the database will be presented in the data listings. Unless 
otherwise stated, all listings will be sorted by study part, subject number, and assessment date/time. 
All summaries will be presented separately for each study part. Unless otherwise stated, the 
descriptions of the analyses which follow will apply to all study parts. 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
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The following labels for treatment will be used on all tabulations where the results are displayed 
by treatment, in the following order: 
• Part 1: 
o Camlipixant 
o Rifampin 
o Camlipixant + Rifampin 
• Part 2: 
o Camlipixant 
o Rabeprazole 
o Camlipixant + Rabeprazole  
For Part 1, where applicable, the treatment phases considered for the safety summaries will be: 
- 
Camlipixant alone – from Day 1 post-dose until Day 4 pre-dose of rifampin; 
- 
Rifampin alone – from Day 4 dosing until Day 11 pre-dose of camlipixant; 
- 
Rifampin + Camlipixant – from camlipixant dosing on Day 11 until end of study. 
 
For Part 2, where applicable, the treatment phases considered for the safety summaries will be: 
- 
Camlipixant alone – from Day 1 post-dose until Day 4 pre-dose of rabeprazole; 
- 
Rabeprazole alone – from Day 4 dosing until Day 10 pre-dose of camlipixant; 
- 
Rabeprazole + Camlipixant – from camlipixant dosing on Day 10 until end of study. 
 
 


Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
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6.2 
Summary Statistics: 
Unless otherwise stated, continuous variables will be summarized using the number of 
observations (n), and the statistics mean, median, standard deviation (SD), minimum (min) and 
maximum (max). The min and max values will be presented to the same number of significant 
digits as recorded in the eCRF, mean and median will be presented to one more significant digit 
than the raw data, and the SD will be presented to two more significant digits than the raw data. 
Summaries of change from baseline variables will include only subjects who have both a baseline 
value and corresponding value at the timepoint of interest. Categorical and binary variables will 
be summarized with frequency counts and percentages. Percentages will be rounded to one 
decimal place, with the denominator being the number of participants (N) in the relevant 
population, unless otherwise stated. 
All digits will be used for PK and statistical calculations. For PK tables and listings, the final reportable 
results or data will be presented by rounding off to two decimal digits, except for the following 
situations (this applies to individual data and descriptive statistics): 
• Kel and R-squared (R2) adjusted data shall be rounded off to four decimal digits. 
• PK parameters related to time, such as Tmax, the timepoint where ln-linear Kel calculation 
begins (Kel Lower), and the actual sampling time of the last measurable concentration used 
to estimate the Kel (Kel Upper), must be reported with the same precision as the actual 
sampling time, rounded to three decimal digits. 
• Concentration versus time data, as well as Cmax shall be reported as they appear in the 
corresponding dataset. 
• Ratios and 90% CIs, intra- and inter-subject coefficients of variation (CV), and CV (%) 
will be presented to two decimal places.  
Only data from protocol scheduled (“nominal”) visits will be included in the summary tables. Data 
from unscheduled visits will not be included in the summary tables (unless they were used as 
baseline) but will be included in the listings. 
6.3 
Key Definitions 
Baseline: 
Unless stated otherwise, baseline will be determined for each subject and will be defined as the 
last non-missing measurement (including repeated and unscheduled assessments) obtained prior 
to the first study drug administration. Post baseline will be considered as all measurements 
collected after first study drug administration. “Unknown”, “Not Done”, “Not Applicable” and 
other classifications of missing data will not be considered when calculating baseline observations 
unless the finding is a valid categorical observation. 


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Study Day: 
Study day will be calculated using first study drug administration date as the reference date. If the 
date of interest occurs on or after the first study drug administration date, study day will be 
calculated as (date of interest – first study drug administration date) + 1. If the date of interest 
occurs prior to the first study drug administration date, study day will be calculated as (date of 
interest – first study drug administration date). There will be no study Day 0. 
Prior and Concomitant Medications: 
Prior medications are defined as medications that start and stop prior to the first dose of study drug. 
All other medications will be defined as concomitant medications including those that start prior 
to the first dose of study drug and continue thereafter. Any medications with an unknown start or 
stop date will be assumed to be concomitant medications unless a partial start or stop date indicates 
otherwise. 
6.4 
Missing Data 
There will be no imputation for missing data, unless otherwise specified. Missing data shall be 
presented in subject listings as either “-” (unknown or not evaluated) or “N/A” (not applicable), 
with the corresponding definition in the footnotes. Missing descriptive statistics, or probability 
values (p-values), which cannot be estimated shall be presented as “-”. 
The listings will include the reported date/time, and the imputations rules below will be used if 
needed to classify as prior or concomitant medication, to determine if an AE is non-TEAE or 
TEAE, or to attribute to a particular treatment for the summaries. 
For inclusion in concomitant medication tables, incomplete start and stop dates on the eCRF will 
be imputed as follows: 
• If the start date is incomplete, the following rules will be applied: 
o Missing day: Assume the first day of the month; however, if the partial date and the 
date of first study drug administration lie within the same month and year and the 
date of first study drug administration is not after the stop date of the 
event/medication, set to the date of study drug administration. Otherwise, set to the 
stop date of the event/medication. 
o Missing day and month: Assume January 1st; however, if the partial date and the 
date of first study drug administration lie within the same year and the date of first 
study drug administration is not after the stop date of the event/medication, set to 
the date of first study drug administration. Otherwise, set to the stop date of the 
event/medication. 
o Missing day, month, and year: Assume date of first study drug administration if it 
is not after the stop date for the event/medication. Otherwise, set to the stop date 
for the event/medication. 
• If the stop date is incomplete, the following rules will be applied: 
o Missing day: Assume the last day of the month 
o Missing day and month: Assume the last day of the year 


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Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
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o Missing day, month, and year: Assume that the event/medication is continuing 
o In the case of the death of a subject, and if the imputed end date is after the date of 
death, the end date will be imputed as the date of death. 
• If the stop date is incomplete, imputed end date will be used instead of reported end date. 
AEs without an onset date or time, or AEs with an onset date on the date of first study drug 
administration but without an onset time, will be defined as treatment-emergent, unless an 
incomplete date (e.g., month and year) clearly indicates that the event started prior to the first study 
drug administration, or the AE stop date indicates that the event started and stopped prior to the 
first study drug administration. 
In the case of withdrawal of consent, all data from participants who withdraw from the study will 
be included in all summaries up to the time of withdrawal. For all other withdrawals, all data 
captured will be included in the safety summaries. 
For PK analysis, only observed concentration data will be used in the data analysis except for 
concentration values below the lower limit of quantification (BLQ); see section 8.1. No attempt 
will be made to extrapolate or interpolate estimates for missing data. 
7. Study Population 
7.1 
Subject Disposition 
The number of participants who were screened, enrolled, dosed, completed the study, and 
discontinued from the study, along with reasons for discontinuation, will be summarized. The data 
will be presented by study part, treatment, and overall (frequency counts and the percentage) and 
presented by participant in a data listing. 
7.2 
Protocol Deviations 
Participant data will be examined for evidence of protocol deviations. All protocol deviations will 
be categorized (as critical, major or minor and important/non-important as per ICH E3 definition) 
and presented by participant in a data listing. 
7.3 
Inclusion and Exclusion Criteria 
All recorded inclusion and exclusion criteria status will be presented by participant in a data listing. 
Participant’s inclusion or exclusion from each analysis population will also be presented in a data 
listing. 
7.4 
Demographics and Other Baseline Characteristics 
All demographics and baseline body measurements will be summarized by study part and 
treatment for the safety, and PC and PK parameter populations (if different from safety 
population).  All demographic characteristics will be presented by participant in a data listing. 
Descriptive statistics (n, mean, SD, min, median, and max) will be calculated for continuous 
variables using the last results obtained (scheduled or unscheduled) prior to the first study drug 
administration. Frequency counts and percentages will be tabulated for categorical and binary 
variables. 


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Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
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Controlled Document ID: 2805A.00, Effective Date 29-Jul-2019 
Filing requirements: TMF 
Page 16 of 29 
7.5 
Medical History 
Medical history will be presented by participant in a data listing. The Medical Dictionary for 
Regulatory Activities (MedDRA), Version 26.0 (or more recent version) will be used to classify 
medical history terms by system organ class (SOC) and preferred term (PT). Output data will 
include the MedDRA version used in the study. 
7.6 
Medications 
Medications taken by participants that start and stop before first dosing will be documented as 
prior medications whereas medications taken by participants after dosing (including those that start 
prior to the first dosing and continue thereafter) up to follow-up phone call will be documented as 
concomitant medications. Prior and concomitant medications will be presented by participant in a 
data listing. The World Health Organization Global Drug Dictionary (WHO DD), Version B3, 
March 2023 (or more recent version) will be used to classify medications by anatomical 
therapeutic chemical (ATC) classification code (3rd level) and preferred name. When 3rd level 
classification code is not available, 2nd level classification will be used instead. Output data will 
include the WHO DD version used in the study. 
7.7 
Drug, Cotinine, and Alcohol Screens 
The results of urine drug, urine cotinine, and alcohol breath screen tests will be presented by 
participant in data listings. 
7.8 
Pregnancy Screening 
Pregnancy tests will be performed for all females. The follicle-stimulating hormone (FSH) level 
will be tested in postmenopausal females only. All results will be presented by participant in data 
listings. 
7.9 
Additional Screening Tests 
The results of serology tests and coronavirus 2019 (COVID-19) tests will be presented by 
participant in data listings. 
8. Pharmacokinetic (PK) Analyses 
Phoenix® WinNonlin® software, Version 8.3.4 (or more recent version) will be used for all PK 
analyses. Statistical analyses will be performed using SAS for Windows software. Bioanalysis of 
all samples should be completed prior to the initiation of the PK and statistical analyses. 
All PK concentration and PK parameter analyses will be conducted on the PK concentration 
population and PK parameter population, respectively. 


Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
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PK concentrations, actual times, date/time of study drug administration and sample collection will 
be listed for the PK concentration population by nominal time for each study part, study day, 
participant and treatment, and summarized for the PC population for each study part by treatment 
and timepoint, using descriptive statistics (n, number of BLQs, arithmetic and geometric means, 
SD, geometric SD, CV%, geometric mean CV%, min, max, and median). Individual, mean (±SD) 
concentration, and overlay of individual plasma concentration versus time profile will be presented 
for both linear and semi-logarithmic scales for each study part by treatment for the PC population. 
For ease of presentation, actual and nominal sampling times will be used to present results for 
individual and mean figures, respectively. 
PK parameters will be presented in data listings and summarized in tables for each study part by 
treatment (or day), using descriptive statistics (n, arithmetic mean, SD, %CV, geometric mean, 
geometric SD, geometric mean CV%, minimum, median, and maximum). 
8.1 
Data Handling 
8.1.1 PK Parameters Calculation Rules 
For all PK analyses, concentration values BLQ that occur before the first measurable concentration 
of the study drug will be set to “0.00”; BLQ values that occur after first measurable concentration 
will be set to “missing”. No imputations will be made on BLQ concentrations. 
Invalid concentration values (due to bioanalytical or clinical issues) that occur prior to dosing will 
be replaced by “0.00”. Invalid concentration values that occur after dosing will be set to “missing” 
for tabulation, graphical representation, and calculation purposes. 
The actual clock time for dosing and the actual clock time for each PK sample collection will be 
recorded. For all sampling times, the actual sampling duration will be calculated as the difference 
between the sample collection actual clock time and the actual clock time of dosing. The actual 
post-dose sampling times, expressed in hours and rounded off to three decimal digits, will be used 
to calculate the PK parameters. Pre-dose sampling times will always be reported as zero (0.000), 
regardless of the time difference. Nominal sampling times will be used in concentration tables and 
mean graphs, while actual sampling times for post-dose samples will be used in the individual 
graphs. Actual sampling times for post-dose samples also will be used for PK parameter derivation, 
unless the actual sampling time is missing, in which case, the nominal time will be used. 
8.1.2 Data Presentation Rules 
Non-measurable values reported in the plasma concentration data (i.e. values that are BLQ), will 
be entered as zero for the determination of summary statistics with the exception of geometric 
mean, geometric SD, and geometric CV%, where BLQ values will be imputed as half the lower 
limit of quantification (LLOQ) value. This also applies to any concentrations that are defined as 
PK parameters. Data recorded as “No Result” or “Not Reportable” (NR), “Not Calculated” (NC) 
or “No Sample” (NS) will be handled as missing (i.e. no assumption will be made about the actual 
concentration). 
8.2 
Pharmacokinetic (PK) Parameters 
The PK parameters shown in Table 8.2-1 below, will be calculated, whenever possible, by standard 
non-compartmental methods for camlipixant. 


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Table 8.2-1: PK Parameters 
Parameter  Definition  
AUC0-t 
area under the concentration-time curve from time zero until the last observed 
concentration 
AUC0-inf 
area under the concentration-time curve from time zero to infinity (extrapolated) 
Cl/F 
apparent clearance, calculated as Dose/AUC0-inf 
Cmax  
maximal observed concentration 
Kel 
terminal elimination rate constant 
Residual 
area 
percentage of AUC0-inf due to extrapolation from the time of the last observed 
concentration to infinity, calculated as [1 - (AUC0-t/AUC0-inf)] x 100 
Tmax 
time when the maximal concentration is observed 
T½ el 
terminal elimination half-life, calculated as ln(2)/Kel 
Vz/F 
apparent volume of distribution, calculated as Dose/(Kel x AUC0-inf) 
Additional PK parameters may be calculated as deemed necessary. 
The following information will be presented for rifampin (Part 1): pre-dose concentrations on the 
morning of Days 4, 8, 9, 10, and 11. The following information will be presented for rabeprazole 
(Part 2): pre-dose concentrations on the morning of Days 4, 7, 8, 9, and 10. These data will be 
listed. Any additional PK data will be presented as appropriate.  
Note: Area under the concentration-time curve (AUC) parameters will be calculated using the 
linear up log down trapezoidal method, where the linear trapezoidal rule is used any time the 
concentration data are increasing, and the logarithmic trapezoidal rule is used any time that the 
concentration data are decreasing. 
Note: Kel will be the negative of the estimated slope of the linear regression of the ln-transformed 
plasma concentration versus time profile in the terminal elimination phase. The best fit method 
will be used to calculate the Kel from at least three concentration data points, excluding Cmax. R2 
adjusted, the goodness of fit statistic for the terminal elimination phase, adjusted for the number 
of points used in the estimation of Kel must be ≥ 0.8. If the Kel cannot be measured (e.g.: there are 
fewer than three non-zero concentrations in the terminal elimination phase), the PK parameters 
derived from Kel will be presented in listing(s) but excluded from descriptive statistics in tables. 
All the derived parameters (i.e., AUC0-inf, T½ el, Cl/F and Vd/F) will be also flagged accordingly. 
The timepoint where ln-linear Kel calculation begins (Kel Lower), the actual sampling time of the last 
measurable concentration used to estimate the Kel (Kel Upper), and the R2 adjusted for the ln-linear 
regression for the calculation of the elimination rate constant will be reported. If the Residual area 
is greater than 20%, the individual result should be flagged in the listing, and AUC0-inf removed 
from descriptive statistics and statistical analyses. The derived parameters (i.e., AUC0-inf, Cl/F and 
Vd/F) will be also flagged accordingly in the listing. 
Some PK parameters may not be calculated for all or some participants, at the discretion of the 
Syneos pharmacokineticist if the concentration data is not deemed to be amenable to evaluation. 
Explanations for PK parameters that could not be estimated will be provided in the CSR.  


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8.3 
Assessment of Rifampin Effect (Part 1) 
8.4 
Assessment of Rabeprazole Effect (Part 2) 
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8.5 
Attainment of Steady State 
As supportive data, to assess attainment of steady state, descriptive statistics on pre-dose 
concentrations of rifampin in Part 1 (Days 9, 10, and 11) and rabeprazole in Part 2 (Days 8, 9, and 
10) will be presented. If necessary, additional data may be presented. 
9. Pharmacogenomic Analyses 
 
 
Other possible exploratory markers may be considered as deemed necessary. If applicable, a data 
listing will be provided for the pharmacogenomic population. 
10. Safety 
Safety and tolerability analysis will be performed for all subjects in the safety population. No 
inferential statistical analysis of safety data is planned. 
10.1 Exposure 
Study drug administration will be listed by participant. 
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10.2 Adverse Events (AEs) 
AEs will be coded using MedDRA, Version 26.0 (or more recent version). Output data will include 
the MedDRA version used in the study. AEs will be grouped by SOC and PT and summarized by 
actual treatment phase. The summary tables will present the number and percentage of total 
participants and number of events by SOC and by PT. 
All AE summaries will be restricted to treatment-emergent AEs (TEAEs), defined as AEs that 
commence on or after the time of first study drug administration. Any AE that first occurs pre-dose 
but worsens in severity after the first study drug administration will also be considered a TEAE. 
TEAEs will be attributed to the appropriate treatment phase as defined previously based on their 
onset date and time. TEAEs continuing after administration on the next treatment phase will be 
evaluated on a case-by-case basis (e.g., If there was no worsening in severity, it would be attributed 
to the treatment phase that coincides with the AE onset. If there was worsening in severity, it would 
be attributed to the treatment phase during which the worsening of the AE has occurred. The 
relationships could also be considered in this determination). 
The relationships for each TEAE will be evaluated separately for the two drugs administered 
during the treatment phase of respective study part and will be classified according to the study 
protocol as definite, possible, probable, unlikely or not related to respective study drugs. The 
severity of TEAEs will be classified as mild, moderate or severe. 
The number and percentage of subjects experiencing TEAEs and the number of TEAEs will be 
tabulated. Subjects who experience the same TEAE (in terms of MedDRA PT) more than once 
will only be counted once, however, the total number of events will be counted per category. This 
also applies to sub-categories (e.g., SOC, PT) displayed in the summaries. 
The following summaries will be presented: 
• Overall summary of TEAEs 
• TEAEs by SOC and PT 
• TEAEs by SOC, PT, and severity 
• TEAEs by SOC, PT, and relationship to each study drug 
• Serious AEs by SOC and PT 
• AEMIs by SOC and PT 
AEMIs for this study include the following, but not limited to: 
All AEs will be listed. The following listings will be included: Non-TEAEs, TEAEs, serious AEs, 
AEMIs, 
. 
 
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10.3 Laboratory Evaluations 
Laboratory data, including biochemistry, hematology, coagulation, and urinalysis, will be listed 
by participant and summarized overall by study day. Observed values and changes from baseline 
will be presented. 
In addition, a shift table representing the categorical change (low, normal, high) from baseline to 
each post baseline study day will be presented. 
The categorical results of urinalysis will be summarized overall as number and percentage by study 
day. 
Abnormal results will be flagged in the listings. 
If more than one clinical laboratory is used, a formula that takes into consideration the relative 
normal ranges of each test of the laboratories will be utilized to normalize these dataa. The 
conversion formula used for each test will depend on the typical distribution of the normal range 
for the test b. Prior to applying these formulas, units will be adjusted, as necessary. The laboratory 
which has the most results for each parameter will be considered primary in the formulas. 
10.4 Vital Signs 
Vital sign measurements will be listed by participant and summarized overall by study day. 
Observed values and changes from baseline will also be presented. 
In addition, a shift table representing the categorical change (normal, abnormal not clinically 
significant, or abnormal clinically significant) from baseline to each post baseline study day will 
be presented. 
Abnormal results will be flagged in the listings. The normal ranges as per clinical SOP (refer to 
the table below) will also be included in the listing and the summary tables. 
Vital Sign Parameters 
Normal Ranges (inclusive) 
Systolic blood pressure 
90 to 140 mmHg 
Diastolic blood pressure 
50 to 90 mmHg 
Hearth rate 
50 to 100 beats/min 
Respiratory rate 
8 to 20 breaths/min 
Oral temperature 
35.8 to 37.6 ℃ 
10.5 Electrocardiograms (ECGs) 
ECG values will be listed by participant and summarized overall by study day. Observed values 
and changes from baseline will be presented. 
In addition, a shift table representing the categorical change in overall interpretation (normal, 
abnormal not clinically significant, or abnormal clinically significant) from baseline to each post 
baseline study day will be presented. 
Abnormal results will be flagged in the listings. The normal ranges as per clinical SOP (refer to 
the table below) will also be included in the listing and the summary tables. 
 
 


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ECG Parameters 
Normal Ranges (inclusive) 
Hearth rate 
50 to 100 beats/min 
PR interval 
120 to 200 msec 
QRS interval 
70 to 110 msec 
QT interval 
≤ 450 msec 
QTcF interval 
≤ 450 msec 
10.6 Physical Examination 
The results of physical examinations will be listed by participant. Abnormal results will be flagged 
in the listings. 
11. Changes from Analysis Planned in the Protocol 
No changes were made to planned analyses. 
 
 


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12. Programming Considerations 
All TFLs and statistical analyses will be generated using
 release 9.4 (or more 
recent version) (
) software in accordance with Food and Drug 
Administration (FDA) guidelines.
 version 8.3.4 (or more recent version) 
(
) will be used for all PK analyses. This software was validated 
by Syneos in compliance with US 21 CFR Part 11 regulation. 
12.1 General Considerations 
• One 
 program can create several outputs. 
• Each output will be stored in a separate file. 
• Output files will be delivered in rich text format that can be manipulated in MS Word. 
• Numbering of TFLs will follow International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH) guideline E3c. 
12.2 Table, Listing, and Figure Format 
12.2.1 General 
• TFLs will be produced in landscape format. The orientation may be changed to portrait, as 
necessary to allow additional rows to be presented. 
• TFLs will be produced using the Times New Roman font, size 9. The font size may be 
reduced as necessary to allow additional columns to be presented, but not at the expense of 
clarity. 
• The data display for all TFLs will have a minimum blank 1-inch margin on all four sides. 
• Unless otherwise specified, TFLs will be in black and white (no color). 
• Specialized text styles, such as bolding, italics, borders, shading, and superscripted and 
subscripted text, will not be used in the TFLs, unless otherwise specified. On some 
occasions, superscripts 1, 2, or 3 may be used; see below. 
• Standard keyboard characters will be used in the TFLs. Special characters, such as 
non-printable control characters, printer-specific, or font-specific characters, will not be 
used. Hexadecimal-derived characters will be used, where possible, if they are appropriate 
to help display math symbols (e.g., μ). Certain subscripts and superscripts (e.g., cm2, Cmax) 
will be employed on a case-by-case basis. 
• TFLs will be produced using sentence case, unless otherwise specified. 
 
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Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
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Page 25 of 29 
12.2.2 Headers and Footers 
• Times New Roman font, size 9 will be used for TFL headers and footers. 
• All outputs will have the following at the top of each page: Bellus Health  Protocol: 220254 
(BUS-P1-11). 
• All outputs will have page x of y at the top or bottom right corner of each page. TFLs are 
individually paginated in relation to total length (i.e., the page number appears sequentially 
as page x of y, where y is the total number of pages in the output). 
• The data source will be included in the footer, as applicable.  
• The date and time the output was generated will appear, along with the program name, at 
the bottom of each page. 
12.2.3 Display Titles 
Each display title includes the appropriate designation (“Table”, “Figure”, or “Listing”) and a 
numeral, along with a descriptive name (e.g., Table 14.1-1 Subject Enrollment and Disposition). 
The analysis population should also be included in each title. ICH E3 numbering is strongly 
recommended, but Sponsor preferences are obtained for final determination. Display titles are left 
aligned, single spaced, and presented in title case. A solid line spanning the margins will separate 
display titles from column headings. 
12.2.4 Column and Row Headings 
• Column and row headings are presented in title case, with the exception of complete 
sentences, which will be presented in sentence case. 
• In efficacy or pharmacokinetic tables, the variable (or characteristic) column will be on the 
far left, followed by the group columns and overall column (if applicable). P-values may 
be presented under the overall column or in separate p-value column (if applicable). 
Within-treatment comparisons may have p-values presented in a row beneath the summary 
statistics for that treatment. 
• Column and row headings will include “Unit” for numeric variables, as appropriate. 
• Column and row headings will include the number of subjects in the analysis population 
for each group, presented as (N=xx). This is different from the ‘n’ used in descriptive 
statistics, which represents the number of observations. 
• The order of treatments in the tables and listings will be placebo first, in placebo-controlled 
studies, and active comparators first, in active comparator trials, with “overall” (if 
applicable) last. 
12.2.5 Body of the Data Display 
12.2.5.1 General Conventions 
Data in columns of a table or listing are formatted as follows: 
• Alphanumeric values are left aligned. 


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• Whole numbers (e.g., counts) or numerical data are centered aligned. 
12.2.5.2 Table Conventions 
• Units will be included, where available. 
• If the categories of a parameter are ordered, all categories between the maximum and 
minimum category are presented in the table, even if n=0 for all groups in a category 
between the minimum and maximum level for that parameter. See the example for the 
frequency distribution for symptom severity below. If percentages are presented in these 
tables, 0% will not be presented, therefore, counts of zero will be presented as “0”, not “0 
(0%)”. 
Severity Rating N 
Severe 
0 
Moderate 
8 
Mild 
3 
• Where the categories are not ordered (e.g., Reason for Discontinuation), only those 
categories for which there is at least one subject represented will be included. 
• An “Unknown” or “Missing” category will be added to each parameter for which 
information is unavailable for one or more subjects. 
• P-values are presented in the format: 0.xxxx, where xxxx is the value. If the p-value is less 
than 0.0001, it will be presented as “<0.0001.” If the p-value is >0.999, it will be presented 
as “>0.999.” 
• Percentage values are presented in parentheses with no spaces, one space after the count 
[e.g., 7 (12.8%), 13 (5.4%)]. Unless otherwise noted, for all percentages, the denominator 
will be the number of subjects in the analysis population for the group that has an 
observation. Percentages after zero counts are not displayed, and percentages equating to 
100% are presented as “100%” (without decimal places). 
• Unless otherwise noted, tabular displays of data for medical history, prior/concomitant 
medications, and AEs data are presented in alphabetical order. 
• The percentage of subjects is typically calculated as a proportion of the number of subjects 
assessed in the relevant group (or overall) for the analysis population presented; however, 
careful consideration is required in many instances, due to the complicated nature of 
selecting the denominator. Details of this will be presented in footnotes or programming 
notes. 
• In categorical summaries where a subject can be included in more than one category, a 
footnote or programming note will specify whether the subject is included in the summary 
statistics for all relevant categories or just one category and the criteria for selecting the 
category. 


Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
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• Where a category with a subheading (such as SOC) must be split over more than one page, 
present the subheading followed by “(cont.)” at the top of each subsequent page. The 
overall summary statistics for the subheading will only be presented on the first relevant 
page. 
12.2.5.3 Listing Conventions 
• Unless otherwise noted, listings will be sorted for presentation in order of participant 
number, visit/collection day, visit/collection time, and parameter (alphabetic order). 
• Dates are printed in 
 DATE9.format (e.g., “ddMMMyyyy”: 01JUL2000). Missing 
portions of dates are represented on subject listings as dashes (e.g.,--JUL2000). Dates that 
are missing because they are not applicable for the subject are presented as “N/A”, unless 
otherwise specified. 
• All observed time values are presented using a 24-hour clock HH:MM:SS or HH:MM 
format (e.g., 11:26:45, or 11:26). Time will only be reported if it was measured as part of 
the study. 
• Units will be included, where available. 
12.2.5.4 Figure Conventions 
• For safety figures, study visits will be displayed on the X-axis and endpoint (e.g., treatment 
mean change from baseline) values will be displayed on the Y-axis, unless otherwise 
specified. 
• Legends will be used for all figures with more than one variable, group, or item displayed. 
• Units will be included, where available. 
12.2.6 Footnotes 
• A solid line spanning the margins will separate the body of the data display from the 
footnotes. 
• All footnotes will be left aligned, with single spacing, immediately below the solid line 
beneath the data display. 
• Informational footnotes begin with “Note:”. Reference footnotes begin with a reference 
number or letter (e.g., 1, 2, 3 or a, b, c). 
• Each new footnote starts on a new line, where possible. 
• Subject-specific footnotes are avoided, where possible. 
• Footnotes will be used sparingly and add value to the table, figure, or data listing. If more 
than six lines of footnotes are planned, a cover page may be used to display footnotes, and 
only those essential to comprehension of the data will be repeated on each page. 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
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Filing requirements: TMF 
Page 28 of 29 
13. Quality Control 
 programs are developed to produce outputs such as analysis data sets, summary tables, data 
listings, figures, and statistical analyses. These are developed and undergo quality control in 
accordance with the latest versions of SOP 2800d and SOP 2801e. 
 
 
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Statistical Analysis Plan for Interventional Studies (Early Phase) 
Sponsor: Bellus Health; Protocol: 220254 (BUS-P1-11) 
 
This document is confidential. 
SAP Version: Final 1.0 04-Oct-2023 
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Filing requirements: TMF 
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14. Reference List 
 
aChuang-Stein, C., PhD, Research Support Biostatistics Unit, 9164–32–2, The Upjohn Company, 
Kalamazoo, Michigan. (1992). Summarizing Laboratory Data with Different Reference Ranges in 
Multi-Center 
Clinical 
Trials. 
Drug 
Information 
Journal, 
26(1), 
77-84. 
doi:10.1177/009286159202600108 
bKarvanen, J., Signal Processing Laboratory, Helsinki University of Technology, Helsinki, 
Finland. (2003). The Statistical Basis of Laboratory Data Normalization. Drug Information 
Journal, 37(1), 101-107. doi:10.1177/009286150303700112 
cInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for 
Human Use (ICH). (1996). Guideline for Industry, Structure and Content of Clinical Study 
Reports (ICH E3). 
 
 
 
 
 
 
 
 
 
 
 
  
 
End of document 
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The GlaxoSmithKline group of companies 
 
Clinical Study Report 
 
 
Study Protocol Number: 220254 (BUS-P1-11) 
 
 
Page 3 of 3 
 
Statistical Analysis Plan (Table/Figure/Listing Shells) Version 1.0 dated 26-
OCT-2023 


 
26-Oct-2023 (Final 1.0) 
Page 1 of 169 
 
 
Statistical Analysis Plan (Table/ Figure/Listing Shells) 
 
 
Sponsor Name: Bellus Health 
 
Protocol Number: 220254 (BUS-P1-11) 
 
Protocol Title: A Phase 1, 2-Part, Open-label, Fixed-sequence Study Evaluating the Effect of 
Rifampin (Part 1) and Rabeprazole (Part 2) on the Pharmacokinetics of a Single Dose of 
Camlipixant (BLU-5937) 50 mg Tablet in Healthy Participants under Fasting Conditions 
 
Protocol Version and Date: Final, 03-Apr-2023 
 
Sponsor Study Number: BUS-P1-11 
 
Authors: 
, Sr. Principal Biostatistician 
, Technical Writer 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notice of Confidential and Proprietary Information: 
The information contained in this document is confidential belonging to Bellus Health. Acceptance 
of this document constitutes agreement by the recipient that no information contained herein will 
be published or disclosed without prior written authorization from an official of Bellus Health. 
However, this document may be disclosed to the appropriate Institutional Review Board and ethics 
committees or duly authorized representatives of a national regulatory authority under the 
condition that they are requested to keep it confidential. In the event of an actual or suspected 
breach of this obligation, Syneos Health should be notified promptly.  
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
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Revision History 
Version 
Date 
(DD-Mmm-YYYY) 
Document Owner 
Revision Summary 
Final 1.0 
26-Oct-2023 
 
Final version 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
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Approvals 
I confirm that I have reviewed this document and agree with the content. 
Syneos Health Approval 
, 
Sr. Principal Biostatistician 
 
 
Name, Title 
Lead Biostatistician  
 Signature 
 
Date 
(DD-Mmm-YYYY) 
 Manager Statistical 
Programming 
 
Name, Title 
Lead Statistical Programmer 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
, Sr. Biostatistician  
 
 
Name, Title 
Senior Reviewing Biostatistician 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
  
Senior Pharmacokineticist 
 
 
Name, Title 
Lead Pharmacokineticist 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
, Medical Writer II 
 
 
 
Name, Title 
Lead Medical Writer 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
30-Oct-2023
30-Oct-2023
31-Oct-2023
31-Oct-2023
02-Nov-2023
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
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26-Oct-2023 (Final 1.0) 
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Bellus Health Approval 
 
 Ph.D., 
or,  
Head of Biostatistics 
 
Name, Title 
Sponsor Contact 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
, M.Sc., 
, Early Phase Development 
 
 
Name, Title 
Sponsor Contact 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
, BPharm, Ph.D., 
of Clinical Pharmacology 
 
 
Name, Title 
Sponsor Contact 
 Signature 
 
Date 
(DD-Mmm-YYYY) 
 
 
01-Nov-2023
01-Nov-2023
02-Nov-2023
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
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Table of Contents 
1. 
Tables ..................................................................................................................................................................... 9 
Table 14.1-1.1 Subject Enrollment and Disposition - Part 1 ....................................................................................... 10 
Table 14.1-1.2 Subject Enrollment and Disposition - Part 2 ....................................................................................... 12 
Table 14.1-1.3 Analysis Populations - Part 1 .............................................................................................................. 14 
Table 14.1-1.4 Analysis Populations - Part 2 .............................................................................................................. 15 
Table 14.1-2.1 Demographics and Baseline Body Measurements (Safety Population) - Part 1 .................................. 16 
Table 14.1-2.2 Demographics and Baseline Body Measurements (Safety Population) - Part 2 .................................. 19 
Table 14.2-1.1 Plasma Concentrations (ng/mL) of Camlipixant (PK Concentration Population) - Part 1 .................. 22 
Table 14.2-1.2 Plasma Concentrations (ng/mL) of Camlipixant (PK Concentration Population) - Part 2 .................. 24 
Table 14.2-2.1 Plasma PK Parameters of Camlipixant (PK Parameter Population) - Part 1 ....................................... 26 
Table 14.2-2.2 Plasma PK Parameters of Camlipixant (PK Parameter Population) - Part 2 ....................................... 28 
Table 14.2-3 Assessment of Rifampin Effect: DDI (PK Parameter Population) - Part 1 ............................................ 30 
Table 14.2-4 Assessment of Rabeprazole Effect: DDI (PK Parameter Population) - Part 2 ....................................... 31 
Table 14.2-5 Non-Parametric Assessment of Rifampin Effect (PK Parameter Population) - Part 1 ........................... 32 
Table 14.2-6 Non-Parametric Assessment of Rabeprazole Effect (PK Parameter Population) - Part 2 ...................... 33 
Table 14.2-7.1 Attainment of Steady State (ng/mL) (PK Concentration Population) - Part 1 ..................................... 34 
Table 14.2-7.2 Attainment of Steady State (ng/mL) (PK Concentration Population) - Part 2 ..................................... 35 
Table 14.3.1-1.1 Overall Summary of TEAEs (Safety Population) - Part 1 ................................................................ 36 
Table 14.3.1-1.2 Overall Summary of TEAEs (Safety Population) - Part 2 ................................................................ 37 
Table 14.3.1-2.1 TEAEs by SOC and PT (Safety Population) - Part 1 ....................................................................... 38 
Table 14.3.1-2.2 TEAEs by SOC and PT (Safety Population) - Part 2 ....................................................................... 39 
Table 14.3.1-3.1 TEAEs by Severity (Safety Population) - Part 1 .............................................................................. 40 
Table 14.3.1-3.2 TEAEs by Severity (Safety Population) - Part 2 .............................................................................. 42 
Table 14.3.1-4.1 TEAEs by Relationship to Study Drug (Camlipixant) (Safety Population) - Part 1 ......................... 44 
Table 14.3.1-4.2 TEAEs by Relationship to Study Drug (Rifampin) (Safety Population) – Part 1 ............................. 46 
Table 14.3.1-4.3 TEAEs by Relationship to Study Drug (Camlipixant) (Safety Population) - Part 2 ......................... 48 
Table 14.3.1-4.4 TEAEs by Relationship to Study Drug (Rabeprazole) (Safety Population) - Part 2 ........................ 50 
Table 14.3.1-5.1 Serious TEAEs (Safety Population) - Part 1 .................................................................................... 52 
Table 14.3.1-5.2 Serious TEAEs (Safety Population) – Part 2 .................................................................................... 53 
Table 14.3.1-6.1 Treatment-emergent AEMIs (Safety Population) - Part 1 ................................................................ 54 
Table 14.3.1-6.2 Treatment-emergent AEMIs (Safety Population) - Part 2 ................................................................ 55 
Table 14.3.4-1.1 Biochemistry (Safety Population) - Part 1 ........................................................................................ 56 
Table 14.3.4-1.2 Biochemistry (Safety Population) - Part 2 ........................................................................................ 57 
Table 14.3.4-2.1 Biochemistry Shifts from Baseline (Safety Population) - Part 1 ...................................................... 58 
Table 14.3.4-2.2 Biochemistry Shifts from Baseline (Safety Population) - Part 2 ...................................................... 59 
Table 14.3.4-3.1 Hematology (Safety Population) - Part 1 ......................................................................................... 60 
Table 14.3.4-3.2 Hematology (Safety Population) - Part 2 ......................................................................................... 61 
Table 14.3.4-4.1 Hematology Shifts from Baseline (Safety Population) - Part 1 ........................................................ 62 
Table 14.3.4-4.2 Hematology Shifts from Baseline (Safety Population) - Part 2 ........................................................ 63 
Table 14.3.4-5.1 Coagulation (Safety Population) - Part 1 .......................................................................................... 64 
Table 14.3.4-5.2 Coagulation (Safety Population) - Part 2 .......................................................................................... 65 
Table 14.3.4-6.1 Coagulation Shifts from Baseline (Safety Population) - Part 1 ........................................................ 66 
Table 14.3.4-6.2 Coagulation Shifts from Baseline (Safety Population) - Part 2 ........................................................ 67 
Table 14.3.4-7.1 Urinalysis: Quantitative (Safety Population) - Part 1 ....................................................................... 68 
Table 14.3.4-7.2 Urinalysis: Quantitative (Safety Population) - Part 2 ....................................................................... 69 
Table 14.3.4-8.1 Urinalysis: Quantitative Shifts from Baseline (Safety Population) - Part 1 ..................................... 70 
Table 14.3.4-8.2 Urinalysis: Quantitative Shifts from Baseline (Safety Population) - Part 2 ..................................... 71 
Table 14.3.4-9.1 Urinalysis: Categorical (Safety Population) - Part 1 ........................................................................ 72 
Table 14.3.4-9.2 Urinalysis: Categorical (Safety Population) - Part 2 ........................................................................ 73 
Table 14.3.4-10.1 Vital Signs (Safety Population) - Part 1 ......................................................................................... 74 
Table 14.3.4-10.2 Vital Signs (Safety Population) - Part 2 ......................................................................................... 75 
Table 14.3.4-11.1 Vital Signs Shifts from Baseline (Safety Population) - Part 1 ........................................................ 76 
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Table 14.3.4-11.2 Vital Signs Shifts from Baseline (Safety Population) - Part 2 ........................................................ 77 
Table 14.3.4-12.1 ECGs: Quantitative (Safety Population) - Part 1 ............................................................................ 78 
Table 14.3.4-12.2 ECGs: Quantitative (Safety Population) - Part 2 ............................................................................ 79 
Table 14.3.4-13.1 ECGs: Interpretation Shifts from Baseline (Safety Population) - Part 1 ........................................ 80 
Table 14.3.4-13.2 ECGs: Interpretation Shifts from Baseline (Safety Population) - Part 2 ........................................ 81 
2. 
Figures .................................................................................................................................................................. 82 
Figure 14.2-14.1 Individual Plasma Concentrations of Camlipixant - Linear Scale (PK Concentration Population) - 
Part 1 ............................................................................................................................................................................ 83 
Figure 14.2-14.2 Individual Plasma Concentrations of Camlipixant – Linear Scale (PK Concentration Population) – 
Part 2 ............................................................................................................................................................................ 84 
Figure 14.2-15.1 Individual Plasma Concentrations of Camlipixant - Semi-Log Scale (PK Concentration Population) 
- Part 1 ......................................................................................................................................................................... 85 
Figure 14.2-15.2 Individual Plasma Concentrations of Camlipixant – Semi-Log Scale (PK Concentration 
Population) – Part 2 ..................................................................................................................................................... 86 
Figure 14.2-16.1 Mean (±SD) Plasma Concentrations of Camlipixant - Linear Scale (PK Concentration Population) 
- Part 1 ......................................................................................................................................................................... 87 
Figure 14.2-16.2 Mean (±SD) Plasma Concentrations of Camlipixant - Linear Scale (PK Concentration Population) 
- Part 2 ......................................................................................................................................................................... 88 
Figure 14.2-17.1 Mean (±SD) Plasma Concentrations of Camlipixant - Semi-Log Scale (PK Concentration 
Population) - Part 1 ...................................................................................................................................................... 89 
Figure 14.2-17.2 Mean (±SD) Plasma Concentrations of Camlipixant - Semi-Log Scale (PK Concentration 
Population) - Part 2 ...................................................................................................................................................... 90 
Figure 14.2-18.1 Overlay of Individual Plasma Concentrations of Camlipixant - Linear Scale (PK Concentration 
Population) - Part 1 ...................................................................................................................................................... 91 
Figure 14.2-18.2 Overlay of Individual Plasma Concentrations of Camlipixant – Linear Scale (PK Concentration 
Population) – Part 2 ..................................................................................................................................................... 92 
Figure 14.2-19.1 Overlay of Individual Plasma Concentrations of Camlipixant – Semi-Log Scale (PK Concentration 
Population) - Part 1 ...................................................................................................................................................... 93 
Figure 14.2-19.2 Overlay of Individual Plasma Concentrations of Camlipixant – Semi-Log Scale (PK Concentration 
Population) – Part 2 ..................................................................................................................................................... 94 
3. 
Listings ................................................................................................................................................................. 95 
 Output: Assessment of Rifampin Effect: DDI by ANOVA (PK Parameter Population) - Part 1
 ..................................................................................................................................................................................... 96 
 Output: Assessment of Rabeprazole Effect: DDI by ANOVA (PK Parameter Population) - Part 
2 ................................................................................................................................................................................... 97 
 Output: Non-Parametric Assessment of Rifampin Effect (PK Parameter Population) - Part 1 98 
 Output: Non-Parametric Assessment of Rabeprazole Effect (PK Parameter Population) - Part 2
 ..................................................................................................................................................................................... 99 
Listing 16.2.1.1-1 Subject Enrollment (Safety Population) - Part 1 .......................................................................... 100 
Listing 16.2.1.1-2 Subject Enrollment (Safety Population) - Part 2 .......................................................................... 101 
Listing 16.2.1.2-1 Subject Disposition (Safety Population) - Part 1 .......................................................................... 102 
Listing 16.2.1.2-2 Subject Disposition (Safety Population) - Part 2 .......................................................................... 103 
Listing 16.2.2.1-1 Protocol Deviations (Safety Population) - Part 1 ......................................................................... 104 
Listing 16.2.2.1-2 Protocol Deviations (Safety Population) - Part 2 ......................................................................... 105 
Listing 16.2.3.1-1 Inclusion and Exclusion Criteria (Safety Population) - Part 1 ..................................................... 106 
Listing 16.2.3.1-2 Inclusion and Exclusion Criteria (Safety Population) - Part 2 ..................................................... 107 
Listing 16.2.3.2-1 Assignment to Analysis Populations - Part 1 ............................................................................... 108 
Listing 16.2.3.2-2 Assignment to Analysis Populations - Part 2 ............................................................................... 109 
Listing 16.2.4.1-1 Demographics (Safety Population) - Part 1 .................................................................................. 110 
Listing 16.2.4.1-2 Demographics (Safety Population) - Part 2 .................................................................................. 111 
Listing 16.2.4.2-1 Body Measurements (Safety Population) - Part 1 ........................................................................ 112 
Listing 16.2.4.2-2 Body Measurements (Safety Population) - Part 2 ........................................................................ 113 
Listing 16.2.4.3-1 Medical History (Safety Population) - Part 1 ............................................................................... 114 
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Listing 16.2.4.3-2 Medical History (Safety Population) - Part 2 ............................................................................... 115 
 
 ................................................................................................................................................................................... 117 
Listing 16.2.4.5-1 Prior and Concomitant Medications (Safety Population) - Part 1 ................................................ 118 
Listing 16.2.4.5-2 Prior and Concomitant Medications (Safety Population) - Part 2 ................................................ 119 
Listing 16.2.4.6-1 Urine Drug Screen (Safety Population) - Part 1 ........................................................................... 120 
Listing 16.2.4.6-2 Urine Drug Screen (Safety Population) - Part 2 ........................................................................... 121 
Listing 16.2.4.7-1 Alcohol Breath Test (Safety Population) - Part 1 ......................................................................... 122 
Listing 16.2.4.7-2 Alcohol Breath Test (Safety Population) - Part 2 ......................................................................... 123 
Listing 16.2.4.8-1 Urine Cotinine Test (Safety Population) - Part 1 ......................................................................... 124 
Listing 16.2.4.8-2 Urine Cotinine Test (Safety Population) - Part 2 ......................................................................... 125 
Listing 16.2.4.9-1 Pregnancy Test (Safety Population) - Part 1 ................................................................................ 126 
Listing 16.2.4.9-2 Pregnancy Test (Safety Population) - Part 2 ................................................................................ 127 
Listing 16.2.4.10-1 Follicle Stimulating Hormone Test (Safety Population) - Part 1 ............................................... 128 
Listing 16.2.4.10-2 Follicle Stimulating Hormone Test (Safety Population) - Part 2 ............................................... 129 
Listing 16.2.4.11-1 Serology (Safety Population) - Part 1 ......................................................................................... 130 
Listing 16.2.4.11-2 Serology (Safety Population) - Part 2 ......................................................................................... 131 
Listing 16.2.4.12-1 COVID-19 Test (Safety Population) - Part 1 ............................................................................. 132 
Listing 16.2.4.12-2 COVID-19 Test (Safety Population) - Part 2 ............................................................................. 133 
Listing 16.2.5.1-1 Study Drug Administration (Safety Population) - Part 1 ............................................................. 134 
Listing 16.2.5.1-2 Study Drug Administration (Safety Population) - Part 2 ............................................................. 135 
Listing 16.2.6.1-1 Plasma PK Concentrations (PK Concentration Population) - Part 1 ............................................ 136 
Listing 16.2.6.1-2 Plasma PK Concentrations (PK Concentration Population) - Part 2 ............................................ 137 
Listing 16.2.6.2-1 Plasma PK Parameters of (PK Parameter Population) - Part 1 .................................................... 138 
Listing 16.2.6.2-2 Plasma PK Parameters of (PK Parameter Population) - Part 2 .................................................... 139 
Listing 16.2.7.1-1 Non-TEAEs (Safety Population) - Part 1 ..................................................................................... 140 
Listing 16.2.7.1-2 Non-TEAEs (Safety Population) - Part 2 ..................................................................................... 141 
Listing 16.2.7.2-1 TEAEs (Safety Population) - Part 1 ............................................................................................. 142 
Listing 16.2.7.2-2 TEAEs (Safety Population) - Part 2 ............................................................................................. 143 
Listing 16.2.7.3-1 Serious AEs (Safety Population) - Part 1 ..................................................................................... 144 
Listing 16.2.7.3-2 Serious AEs (Safety Population) - Part 2 ..................................................................................... 145 
Listing 16.2.7.4-1 AEMIs (Safety Population) - Part 1 ............................................................................................. 146 
Listing 16.2.7.4-2 AEMIs (Safety Population) - Part 2 ............................................................................................. 147 
Listing 16.2.7.5-1 
............................................. 148 
Listing 16.2.7.5-2 
 ............................................... 149 
Listing 16.2.7.6-1 Oral Hypoesthesia, Oral Paresthesia AE Questionnaire (Safety Population) - Part 1 .................. 150 
Listing 16.2.7.6-2 Oral Hypoesthesia, Oral Paresthesia AE Questionnaire (Safety Population) - Part 2 .................. 151 
Listing 16.2.8.1-1 Biochemistry (Safety Population) - Part 1 ................................................................................... 152 
Listing 16.2.8.1-2 Biochemistry (Safety Population) - Part 2 ................................................................................... 153 
Listing 16.2.8.2-1 Hematology (Safety Population) - Part 1 ..................................................................................... 154 
Listing 16.2.8.2-2 Hematology (Safety Population) - Part 2 ..................................................................................... 155 
Listing 16.2.8.3-1 Coagulation (Safety Population) - Part 1 ..................................................................................... 156 
Listing 16.2.8.3-2 Coagulation (Safety Population) - Part 2 ..................................................................................... 157 
Listing 16.2.8.4-1 Urinalysis: Quantitative (Safety Population) - Part 1 ................................................................... 158 
Listing 16.2.8.4-2 Urinalysis: Quantitative (Safety Population) - Part 2 ................................................................... 159 
Listing 16.2.8.5-1 Urinalysis: Categorical (Safety Population) - Part 1 .................................................................... 160 
Listing 16.2.8.5-2 Urinalysis: Categorical (Safety Population) - Part 2 .................................................................... 161 
Listing 16.2.8.6-1 Vital Signs (Safety Population) - Part 1 ....................................................................................... 162 
Listing 16.2.8.6-2 Vital Signs (Safety Population) - Part 2 ....................................................................................... 163 
Listing 16.2.8.7-1 ECGs (Safety Population) - Part 1 ............................................................................................... 164 
Listing 16.2.8.7-2 ECGs (Safety Population) - Part 2 ............................................................................................... 165 
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Listing 16.2.8.8-1 Physical Examination (Safety Population) - Part 1 ...................................................................... 166 
Listing 16.2.8.8-2 Physical Examination (Safety Population) - Part 2 ...................................................................... 167 
Listing 16.2.8.8-3 Pharmacogenomic Measurements (Pharmacogenomic Population) - Part 1 ................................ 168 
Listing 16.2.8.8-4 Pharmacogenomic Measurements (Pharmacogenomic Population) - Part 2 ................................ 169 
 
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1. Tables  
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Table 14.1-1.1 Subject Enrollment and Disposition - Part 1  
Category 
Camlipixant 
(N=xx) 
Rifampin 
(N=xx) 
Camlipixant + Rifampin 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
Screened, n 
- 
- 
- 
xx 
Screening Failures[a][b], n (%) 
- 
- 
- 
xx (xx.x) 
Not Enrolled[a][c], n (%) 
- 
- 
- 
xx (xx.x) 
Enrolled[a][d], n (%) 
- 
- 
- 
xx (xx.x) 
 
 
 
 
 
Dosed [e], n 
xx  
xx 
xx 
xx 
Not Dosed, n 
xx 
xx 
xx 
- 
 
 
 
 
 
Completed [f][g], n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Did Not Complete [g], n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Reason For Non-completion[h], n (%): 
 
 
 
 
   Adverse Event 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Lost To Follow-up 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Non-Compliance With Study Drug 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Physician Decision 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Pregnancy 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Protocol Deviation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Site Terminated By Sponsor 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Study Terminated By Sponsor 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Technical Problems 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Withdrawal by Participant 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Withdrawal of Consent 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Other 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
 
 
 
 
 
Abbreviations: N=Number of participants in the population; n=Number of participants; n (%)= number and percent of participants 
[a] Percentage is based on the number of screened volunteers. 
[b] Screening failures include volunteers who did not meet study criteria. 
[c] Not enrolled include volunteers who were judged eligible but decided not to participate on study or who were not selected to participate in the study since 
there was already a sufficient number of volunteers. 
[d] Enrolled includes volunteers who were judged eligible and accepted to participate in the trial after having signed the approved final version of the study 
informed consent form and those identified as standby who may replace participants who withdraw from the study before dosing. 
[e] Includes all participants who received at least one dose of the study drug. 
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[f] Number of participants who completed the respective treatment phase. 
[g] Percentage is based on the number of dosed participants. 
[h] Percentage is based on the number of participants that did not complete the study. 
Note: The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
 from Day 4 to Day 10, rifampin 
mg 
from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
 
Data Sources: Listing 16.2.1.1-1, Listing 16.2.1.2-1, Listing 16.2.3.1-1, and Listing 16.2.5.1-1. 
 
 
 
 
 
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Table 14.1-1.2 Subject Enrollment and Disposition - Part 2  
Category 
Camlipixant 
(N=xx) 
Rabeprazole  
(N=xx) 
Camlipixant + Rabeprazole  
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
Screened, n 
- 
- 
- 
xx 
Screening Failures[a][b], n (%) 
- 
- 
- 
xx (xx.x) 
Not Enrolled[a][c], n (%) 
- 
- 
- 
xx (xx.x) 
Enrolled[a][d], n (%) 
- 
- 
- 
xx (xx.x) 
 
 
 
 
 
Dosed [e], n 
xx 
xx 
xx 
xx 
Not Dosed, n 
xx 
xx 
xx 
- 
 
 
 
 
 
Completed [f][g], n (%) 
xx 
xx 
xx 
xx (xx.x) 
Did Not Complete [g], n (%) 
xx 
xx 
xx 
xx (xx.x) 
 
 
 
 
 
Reason For Non-completion[h], n (%): 
 
 
 
 
   Adverse Event 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Death 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Lost To Follow-up 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Non-Compliance With Study Drug 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Physician Decision 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Pregnancy 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Protocol Deviation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Site Terminated By Sponsor 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Study Terminated By Sponsor 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Technical Problems 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Withdrawal by Participant 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Withdrawal of Consent 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
   Other 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
- 
 
 
 
 
 
Abbreviations: N=Number of participants in the population; n=Number of participants; n (%)= number and percent of participants 
[a] Percentage is based on the number of screened volunteers. 
[b] Screening failures include volunteers who did not meet study criteria. 
[c] Not enrolled include volunteers who were judged eligible but decided not to participate on study or who were not selected to participate in the study since 
there was already a sufficient number of volunteers. 
[d] Enrolled includes volunteers who were judged eligible and accepted to participate in the trial after having signed the approved final version of the study 
informed consent form and those identified as standby who may replace participants who withdraw from the study before dosing. 
[e] Includes all participants who received at least one dose of the study drug. 
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[f] Number of participants who completed the respective treatment phase. 
[g] Percentage is based on the number of dosed participants. 
[h] Percentage is based on the number of participants that did not complete the study. 
Note: The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
from Day 4 to Day 9, rabeprazole 
mg 
 from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
 
Data Sources: Listing 16.2.1.1-2, Listing 16.2.1.2-2, Listing 16.2.3.1-2, and Listing 16.2.5.1-2. 
 
 
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Table 14.1-1.3 Analysis Populations - Part 1  
Analysis Population 
Overall 
(N=xx) 
 
 
Safety Population, n (%) 
xx (xx.x) 
PK Concentration Population, n (%) 
xx (xx.x) 
PK Parameter Population, n (%) 
xx (xx.x) 
Pharmacogenomic Population, n (%) 
xx (xx.x) 
 
 
Abbreviations: N=Number of participants dosed; n=Number of participants; n (%)= number and percent of participants 
 
 
Data Source: Listing 16.2.3.2-1 
 
 
 
 
 
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Table 14.1-1.4 Analysis Populations - Part 2  
Analysis Population 
Overall 
(N=xx) 
 
 
Safety Population, n (%) 
xx (xx.x) 
PK Concentration Population, n (%) 
xx (xx.x) 
PK Parameter Population, n (%) 
xx (xx.x) 
Pharmacogenomic Population, n (%) 
xx (xx.x) 
 
 
Abbreviations: N=Number of participants dosed; n=Number of participants; n (%)= number and percent of participants 
 
Data Source: Listing 16.2.3.2-2 
 
 
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Table 14.1-2.1 Demographics and Baseline Body Measurements (Safety Population) - Part 1 
Category 
Camlipixant 
(N=xx) 
Rifampin 
(N=xx) 
Camlipixant + Rifampin 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
Age (years) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean 
xx.x 
xx.x 
xx.x 
xx.x 
   SD 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   Min 
xx 
xx 
xx 
xx 
   Median 
xx.x 
xx.x 
xx.x 
xx.x 
   Max 
xx 
xx 
xx 
xx 
 
 
 
 
 
Sex n (%) 
 
 
 
 
   Male 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Female 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Childbearing Potential[a], n (%) 
 
 
 
 
 
 
   Yes 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   No 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Reason for Non-Childbearing Potential[b], n (%) 
 
 
 
 
   Pre-Menopause 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Menopause 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Post-Menopause 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Surgically Sterile 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Ethnicity, n (%) 
 
 
 
 
   Hispanic or Latino 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Not Hispanic or Latino 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Not Reported 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Unknown 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 17 of 169 
 
Category 
Camlipixant 
(N=xx) 
Rifampin 
(N=xx) 
Camlipixant + Rifampin 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
(cont.) 
 
 
 
 
Race, n (%) 
 
 
 
 
   Am Indian  
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Asian  
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Black 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Hawaiian 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   White 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Not Reported  
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Unknown 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Multiple 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Other 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Height (cm) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean 
xx.x 
xx.x 
xx.x 
xx.x 
   SD 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   Min 
xx 
xx 
xx 
xx 
   Median 
xx.x 
xx.x 
xx.x 
xx.x 
   Max 
xx 
xx 
xx 
xx 
 
 
 
 
 
Weight (kg) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   SD 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
   Min 
xx.x 
xx.x 
xx.x 
xx.x 
   Median 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   Max 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
BMI (kg/m2) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   SD 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
   Min 
xx.x 
xx.x 
xx.x 
xx.x 
   Median 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   Max 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 18 of 169 
 
Abbreviations: Am Indian= American Indian or Alaskan native; Black= Black or African American; BMI= body mass index; Hawaiian= native Hawaiian or 
other pacific islander; N=Number of participants in the population; n (%)=Number and percent of participants; n= number of observations; max= maximum; 
min= minimum; SD= standard deviation 
[a] Percentage is based on the number of females. 
[b] Percentage is based on the number of females of non-childbearing potential. 
Note: The last result (scheduled or unscheduled) obtained prior to the first study drug administration was used to generate this table.  
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
 from Day 4 to Day 10, rifampin 
mg 
 from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
 
Data Source: Listing 16.2.4.1-1 and Listing 16.2.4.2-1 
 
Note: if N is different for safety and PC / PK populations, please include a Demographics and Baseline Body measurements table for PC / PK populations. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 19 of 169 
 
Table 14.1-2.2 Demographics and Baseline Body Measurements (Safety Population) - Part 2 
Category 
Camlipixant 
(N=xx) 
Rabeprazole  
(N=xx) 
Camlipixant + Rabeprazole 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
Age (years) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean 
xx.x 
xx.x 
xx.x 
xx.x 
   SD 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   Min 
xx 
xx 
xx 
xx 
   Median 
xx.x 
xx.x 
xx.x 
xx.x 
   Max 
xx 
xx 
xx 
xx 
 
 
 
 
 
Sex, n (%) 
 
 
 
 
   Male 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Female 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Childbearing Potential[a], n (%) 
 
 
 
 
 
 
   Yes 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   No 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Reason for Non-Childbearing Potential[b], n (%) 
 
 
 
 
   Pre-Menopause 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Menopause 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Post-Menopause 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Surgically Sterile 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Ethnicity, n (%) 
 
 
 
 
   Hispanic or Latino 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Not Hispanic or Latino 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Not Reported 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Unknown 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 20 of 169 
 
Category 
Camlipixant 
(N=xx) 
Rabeprazole  
(N=xx) 
Camlipixant + Rabeprazole 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
(cont.) 
 
 
 
 
Race, n (%) 
 
 
 
 
   Am Indian  
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Asian  
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Black 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Hawaiian 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   White 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Not Reported  
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Unknown 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Multiple 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
   Other 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Height (cm) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean 
xx.x 
xx.x 
xx.x 
xx.x 
   SD 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   Min 
xx 
xx 
xx 
xx 
   Median 
xx.x 
xx.x 
xx.x 
xx.x 
   Max 
xx 
xx 
xx 
xx 
 
 
 
 
 
Weight (kg) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   SD 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
   Min 
xx.x 
xx.x 
xx.x 
xx.x 
   Median 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   Max 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
BMI (kg/m2) 
 
 
 
 
   n 
xx 
xx 
xx 
xx 
   Mean 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   SD 
xx.xxx 
xx.xxx 
xx.xxx 
xx.xxx 
   Min 
xx.x 
xx.x 
xx.x 
xx.x 
   Median 
xx.xx 
xx.xx 
xx.xx 
xx.xx 
   Max 
xx.x 
xx.x 
xx.x 
xx.x 
 
 
 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 21 of 169 
 
Abbreviations: Am Indian= American Indian or Alaskan native; Black= Black or African American; BMI= body mass index; Hawaiian= native Hawaiian or 
other pacific islander; N=Number of participants in the population; n (%)=Number and percent of participants; n= number of observations; max= maximum; 
min= minimum; SD= standard deviation 
[c] Percentage is based on the number of females. 
[d] Percentage is based on the number of females of non-childbearing potential. 
Note: The last result (scheduled or unscheduled) obtained prior to the first study drug administration was used to generate this table.  
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole
 mg 
 from Day 4 to Day 9, rabeprazole 
mg 
from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
 
Data Source: Listing 16.2.4.1-2 and Listing 16.2.4.2-2 
 
Note: if N is different for safety and PC / PK populations, please include a Demographics and Baseline Body measurements table for PC / PK populations. 
 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 22 of 169 
 
Table 14.2-1.1 Plasma Concentrations (ng/mL) of Camlipixant (PK Concentration Population) - Part 1 
Timepoint  
   Statistic 
Camlipixant (Day 1) 
(N=xx) 
Camlipixant + Rifampin (Day 11) 
(N=xx) 
 
 
 
Pre-dose  
 
 
   n 
xx 
xx 
   Number of BLQs 
xx 
xx 
   Mean 
xxxx.xx 
xxxx.xx 
   SD 
xxxx.xx 
xxxx.xx 
   CV% 
xxx.xx 
xxx.xx 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
   Geometric SD 
xxxx.xx 
xxxx.xx 
   Geometric CV% 
xxx.xx 
xxx.xx 
   Min 
xxxx.xx 
xxxx.xx 
   Median 
xxxx.xx 
xxxx.xx 
   Max 
xxxx.xx 
xxxx.xx 
 
 
 
x.xx 
 
 
   n 
xx 
xx 
   Number of BLQs 
xx 
xx 
   Mean 
xxxx.xx 
xxxx.xx 
   SD 
xxxx.xx 
xxxx.xx 
   CV% 
xxx.xx 
xxx.xx 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
   Geometric SD 
xxxx.xx 
xxxx.xx 
   Geometric CV% 
xxx.xx 
xxx.xx 
   Min 
xxxx.xx 
xxxx.xx 
   Median 
xxxx.xx 
xxxx.xx 
   Max 
xxxx.xx 
xxxx.xx 
 
 
 
… 
 
 
 
 
 
Abbreviations: BLQ=Below lower limit of quantification; CV%=Coefficient of variation (percent); max=Maximum; min=Minimum; N=Number of participants 
in the population; n=Number of observations; PK=Pharmacokinetic(s); SD=Standard deviation; ‘-’=Not calculated 
Note: BLQ values were entered as zero for the determination of summary statistics with the exception of geometric mean, geometric SD, and geometric CV%, 
where BLQ values were imputed as half the lower limit of quantification (LLOQ) value. The LLOQ for camlipixant was 1 ng/mL. 
Data Source: Listing 16.2.6.1-1 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 23 of 169 
 
Programming Notes:  
1) Sort by timepoint. 
2) Present all scheduled timepoints. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 24 of 169 
 
Table 14.2-1.2 Plasma Concentrations (ng/mL) of Camlipixant (PK Concentration Population) - Part 2 
Timepoint  
   Statistic 
Camlipixant (Day 1) 
(N=xx) 
Camlipixant + Rabeprazole (Day 10) 
(N=xx) 
 
 
 
Pre-dose  
 
 
   n 
xx 
xx 
   Number of BLQs 
xx 
xx 
   Mean 
xxxx.xx 
xxxx.xx 
   SD 
xxxx.xx 
xxxx.xx 
   CV% 
xxx.xx 
xxx.xx 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
   Geometric SD 
xxxx.xx 
xxxx.xx 
   Geometric CV% 
xxx.xx 
xxx.xx 
   Min 
xxxx.xx 
xxxx.xx 
   Median 
xxxx.xx 
xxxx.xx 
   Max 
xxxx.xx 
xxxx.xx 
 
 
 
x.xx 
 
 
   n 
xx 
xx 
   Number of BLQs 
xx 
xx 
   Mean 
xxxx.xx 
xxxx.xx 
   SD 
xxxx.xx 
xxxx.xx 
   CV% 
xxx.xx 
xxx.xx 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
   Geometric SD 
xxxx.xx 
xxxx.xx 
   Geometric CV% 
xxx.xx 
xxx.xx 
   Min 
xxxx.xx 
xxxx.xx 
   Median 
xxxx.xx 
xxxx.xx 
   Max 
xxxx.xx 
xxxx.xx 
 
 
 
… 
 
 
 
 
 
Abbreviations: BLQ=Below lower limit of quantification; CV%=Coefficient of variation (percent); max=Maximum; min=Minimum; N=Number of participants 
in the population; n=Number of observations; PK=Pharmacokinetic(s); SD=Standard deviation; ‘-’=Not calculated 
Note: BLQ values were entered as zero for the determination of summary statistics with the exception of geometric mean, geometric SD, and geometric CV%, 
where BLQ values were imputed as half the lower limit of quantification (LLOQ) value. The LLOQ for camlipixant was 1 ng/mL. 
 
Data Source: Listing 16.2.6.1-2 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 25 of 169 
 
 
Programming Notes:  
1) Sort by timepoint. 
2) Present all scheduled timepoints. 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 26 of 169 
 
Table 14.2-2.1 Plasma PK Parameters of Camlipixant (PK Parameter Population) - Part 1 
Parameter (unit) 
   Statistic 
Camlipixant (Day 1) 
(N=xx) 
Camlipixant + Rifampin (Day 11) 
(N=xx) 
 
 
 
AUC0-t (xx) 
 
 
   n 
xx 
xx 
   Mean  
xxxx.xx 
xxxx.xx 
   SD 
xxxx.xx 
xxxx.xx 
   CV% 
xxx.xx 
xxx.xx 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
   Geometric SD 
xxxx.xx 
xxxx.xx 
   Geometric CV% 
xxx.xx 
xxx.xx 
   Min 
xxxx.xx 
xxxx.xx 
   Median 
xxxx.xx 
xxxx.xx 
   Max 
xxxx.xx 
xxxx.xx 
 
 
 
AUC0-inf (xx) 
 
 
   n 
xx 
xx 
   Mean 
xxxx.xx 
xxxx.xx 
   SD 
xxxx.xx 
xxxx.xx 
   CV% 
xxx.xx 
xxx.xx 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
   Geometric SD 
xxxx.xx 
xxxx.xx 
   Geometric CV% 
xxx.xx 
xxx.xx 
   Min 
xxxx.xx 
xxxx.xx 
   Median 
xxxx.xx 
xxxx.xx 
   Max 
xxxx.xx 
xxxx.xx 
 
 
 
… 
 
 
 
 
 
Abbreviations: CV%=Coefficient of variation (percent); max=Maximum; min=Minimum; N=Number of participants in the population; n=Number of 
observations; PK=Pharmacokinetic(s); SD=Standard deviation; ‘-’=Not calculated 
 
 
Data Source: Listing 16.2.6.2-1 
 
Programming Notes:  
1) Geometric mean will be set to “-” if minimum is zero. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 27 of 169 
 
2) Present all PK parameters in the order in which they are presented in the corresponding listing. 
3) Add abbreviations used in the table to the footnotes. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 28 of 169 
 
Table 14.2-2.2 Plasma PK Parameters of Camlipixant (PK Parameter Population) - Part 2 
Parameter (unit) 
   Statistic 
Camlipixant (Day 1) 
(N=xx) 
Camlipixant + Rabeprazole (Day 10) 
(N=xx) 
 
 
 
AUC0-t (xx) 
 
 
   n 
xx 
xx 
   Mean  
xxxx.xx 
xxxx.xx 
   SD 
xxxx.xx 
xxxx.xx 
   CV% 
xxx.xx 
xxx.xx 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
   Geometric SD 
xxxx.xx 
xxxx.xx 
   Geometric CV% 
xxx.xx 
xxx.xx 
   Min 
xxxx.xx 
xxxx.xx 
   Median 
xxxx.xx 
xxxx.xx 
   Max 
xxxx.xx 
xxxx.xx 
 
 
 
AUC0-inf (xx) 
 
 
   n 
xx 
xx 
   Mean 
xxxx.xx 
xxxx.xx 
   SD 
xxxx.xx 
xxxx.xx 
   CV% 
xxx.xx 
xxx.xx 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
   Geometric SD 
xxxx.xx 
xxxx.xx 
   Geometric CV% 
xxx.xx 
xxx.xx 
   Min 
xxxx.xx 
xxxx.xx 
   Median 
xxxx.xx 
xxxx.xx 
   Max 
xxxx.xx 
xxxx.xx 
 
 
 
… 
 
 
 
 
 
Abbreviations: CV%=Coefficient of variation (percent); max=Maximum; min=Minimum; N=Number of participants in the population; n=Number of 
observations; PK=Pharmacokinetic(s); SD=Standard deviation; ‘-’=Not calculated 
 
Data Source: Listing 16.2.6.2-2 
 
Programming Notes:  
1) Geometric mean will be set to “-” if minimum is zero. 
2) Present all PK parameters in the order in which they are presented in the corresponding listing. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 29 of 169 
 
3) Add abbreviations used in the table to the footnotes. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 30 of 169 
 
Table 14.2-3 Assessment of Rifampin Effect: DDI (PK Parameter Population) - Part 1 
Parameter (unit) 
Treatment / Treatment 
Comparison 
Geometric 
LSM 
Geometric 
LSM Ratio 
(%)[a] 
90% CIs for the 
Geometric LSM 
Ratio (%)b] 
Was the criteria 
for no DDI met? 
[c] 
Intra-
Subject 
CV (%)[d] 
Inter-
Subject 
CV (%)[e] 
p-value 
Treatment 
 
 
 
 
 
 
 
 
 
AUC0-t (xx) 
Camlipixant 
xxx.xx 
 
 
 
 
 
 
(n=xx) 
Camlipixant + Rifampin 
xxx.xx 
 
 
 
 
 
 
 
Camlipixant + Rifampin vs 
Camlipixant 
 
xx.xx 
xx.xx, xx.xx 
Yes 
xxx.xx 
xxx.xx 
0.xxxx 
 
 
 
 
 
 
 
 
 
AUC0-inf (xx) 
Camlipixant 
xxx.xx 
 
 
 
 
 
 
(n=xx) 
Camlipixant + Rifampin 
xxx.xx 
 
 
 
 
 
 
 
Camlipixant + Rifampin vs 
Camlipixant 
 
xx.xx 
xx.xx, xx.xx 
Yes 
xxx.xx 
xxx.xx 
0.xxxx 
 
 
 
 
 
 
 
 
 
Cmax (xx) 
Camlipixant 
xxx.xx 
 
 
 
 
 
 
(n=xx) 
Camlipixant + Rifampin 
xxx.xx 
 
 
 
 
 
 
 
Camlipixant + Rifampin vs 
Camlipixant 
 
xx.xx 
xx.xx, xx.xx 
Yes 
xxx.xx 
xxx.xx 
0.xxxx 
 
 
 
 
 
 
 
 
 
Abbreviations: ANOVA=Analysis of variance; CI=Confidence interval; CV=Coefficient of variation; DDI=Drug-drug interaction; exp=Exponential; df=Degrees 
of freedom; LSM=Least square means; n=Number of participants included in the analysis; p-value=Probability value; PK=Pharmacokinetic(s); SE=Standard 
error; SQRT=Square root; vs=Versus. 
[a] The geometric LSM ratio (camlipixant + rifampin/camlipixant) is calculated using LSM according to the following formula: exp (DIFFERENCE) * 100. 
[b] The 90% geometric CI is calculated according to the following formula: exp (DIFFERENCE ± t(dfResidual)* SEDIFFERENCE) * 100. 
[c] The ratio of geometric means (camlipixant + rifampin/camlipixant) and 90% CIs for the ratio of geometric means, based on least squares means from the 
repeated measure ANOVA of the ln transformed AUC0-t, AUC0-inf, and Cmax must be within 80 % to 125 % to demonstrate no DDI. 
[d] Calculated according to formula: SQRT (exp (residual variance) – 1) * 100.  
[e] Calculated according to formula: SQRT (exp (subject variance) – 1) * 100.  
 
Data Source: Listing 16.2.6.2-1 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 31 of 169 
 
Table 14.2-4 Assessment of Rabeprazole Effect: DDI (PK Parameter Population) - Part 2 
Parameter (unit) 
Treatment / Treatment 
Comparison 
Geometric 
LSM 
Geometric 
LSM Ratio 
(%)[a] 
90% CIs for the 
Geometric LSM 
Ratio (%)b] 
Was the criteria 
for no DDI met? 
[c] 
Intra-
Subject 
CV (%)[d] 
Inter-
Subject 
CV (%)[e] 
p-value 
Treatment 
 
 
 
 
 
 
 
 
 
AUC0-t (xx) 
Camlipixant 
xxx.xx 
 
 
 
 
 
 
(n=xx) 
Camlipixant + Rabeprazole 
xxx.xx 
 
 
 
 
 
 
 
Camlipixant + Rabeprazole 
vs Camlipixant 
 
xx.xx 
xx.xx, xx.xx 
Yes 
xxx.xx 
xxx.xx 
0.xxxx 
 
 
 
 
 
 
 
 
 
AUC0-inf (xx) 
Camlipixant 
xxx.xx 
 
 
 
 
 
 
(n=xx) 
Camlipixant + Rabeprazole 
xxx.xx 
 
 
 
 
 
 
 
Camlipixant + Rabeprazole 
vs Camlipixant 
 
xx.xx 
xx.xx, xx.xx 
Yes 
xxx.xx 
xxx.xx 
0.xxxx 
 
 
 
 
 
 
 
 
 
Cmax (xx) 
Camlipixant 
xxx.xx 
 
 
 
 
 
 
(n=xx) 
Camlipixant + Rabeprazole 
xxx.xx 
 
 
 
 
 
 
 
Camlipixant + Rabeprazole 
vs Camlipixant 
 
xx.xx 
xx.xx, xx.xx 
Yes 
xxx.xx 
xxx.xx 
0.xxxx 
 
 
 
 
 
 
 
 
 
Abbreviations: ANOVA=Analysis of variance; CI=Confidence interval; CV=Coefficient of variation; DDI=Drug-drug interaction; exp=Exponential; df=Degrees 
of freedom; LSM=Least square means; n=Number of participants included in the analysis; p-value=Probability value; PK=Pharmacokinetic(s); SE=Standard 
error; SQRT=Square root; vs=Versus. 
[a] The geometric LSM ratio (camlipixant + rabeprazole/camlipixant) is calculated using LSM according to the following formula: exp (DIFFERENCE) * 100. 
[b] The 90% geometric CI is calculated according to the following formula: exp (DIFFERENCE ± t(dfResidual)* SEDIFFERENCE) * 100. 
[c] The ratio of geometric means (camlipixant + rabeprazole/camlipixant) and 90% CIs for the ratio of geometric means, based on least squares means from the 
repeated measure ANOVA of the ln transformed AUC0-t, AUC0-inf, and Cmax must be within 80 % to 125 % to demonstrate no DDI. 
[d] Calculated according to formula: SQRT (exp (residual variance) – 1) * 100.  
[e] Calculated according to formula: SQRT (exp (subject variance) – 1) * 100.  
 
Data Source: Listing 16.2.6.2-2 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 32 of 169 
 
Table 14.2-5 Non-Parametric Assessment of Rifampin Effect (PK Parameter Population) - Part 1 
Plasma PK 
Parameter (unit) 
Number of 
Participants 
Included in the 
Analysis 
 
 
Treatment Comparison 
Median of Paired Difference 
Signed-Rank  p-value 
 
 
 
 
 
Tmax (unit) 
xx 
Camlipixant + Rifampin vs Camlipixant 
xx.xxx 
x.xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: p-value=Probability value 
 
Data Source: Listing 16.2.6.2-1 
 
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Table 14.2-6 Non-Parametric Assessment of Rabeprazole Effect (PK Parameter Population) - Part 2 
Plasma PK Parameter 
(unit) 
Number of 
Participants 
Included in the 
Analysis 
 
 
Treatment Comparison 
Median of Paired Difference 
Signed-Rank  p-value 
 
 
 
 
 
Tmax (unit) 
xx 
Camlipixant + Rabeprazole vs Camlipixant 
xx.xxx 
x.xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: p-value=Probability value 
 
Data Source: Listing 16.2.6.2-2 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 34 of 169 
 
Table 14.2-7.1 Attainment of Steady State (ng/mL) (PK Concentration Population) - Part 1 
Analyte 
   Statistic 
Day 9 Pre-dose 
(N=xx) 
Day 10 Pre-dose 
(N=xx) 
Day 11 Pre-dose 
(N=xx) 
Rifampin 
   n 
xx 
xx 
xx 
 
   Number of BLQs 
xx 
xx 
xx 
 
   Mean 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   SD 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   CV% 
xxx.xx 
xxx.xx 
xxx.xx 
 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   Geometric SD 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   Geometric CV% 
xxx.xx 
xxx.xx 
xxx.xx 
 
   Min 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   Median 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   Max 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
 
 
 
 
Abbreviations: BLQ=Below lower limit of quantification; CV%=Coefficient of variation (percent); max=Maximum; min=Minimum; N=Number of participants 
in the population; n=Number of observations; PK=Pharmacokinetic(s); SD=Standard deviation; ‘-’=Not calculated 
Note: BLQ values were entered as zero for the determination of summary statistics with the exception of geometric mean, geometric SD, and geometric CV%, 
where BLQ values were imputed as half the lower limit of quantification (LLOQ) value. The LLOQ for rifampin was 5 ng/mL. 
 
Data Source: Listing 16.2.6.1-1 
 
 
 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
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Table 14.2-7.2 Attainment of Steady State (ng/mL) (PK Concentration Population) - Part 2 
Analyte 
   Statistic 
Day 8 Pre-dose 
(N=xx) 
Day 9 Pre-dose 
(N=xx) 
Day 10 Pre-dose 
(N=xx) 
Rabeprazole 
   n 
xx 
xx 
xx 
 
   Number of BLQs 
xx 
xx 
xx 
 
   Mean 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   SD 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   CV% 
xxx.xx 
xxx.xx 
xxx.xx 
 
   Geometric Mean 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   Geometric SD 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   Geometric CV% 
xxx.xx 
xxx.xx 
xxx.xx 
 
   Min 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   Median 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
   Max 
xxxx.xx 
xxxx.xx 
xxxx.xx 
 
 
 
 
 
Abbreviations: BLQ=Below lower limit of quantification; CV%=Coefficient of variation (percent); max=Maximum; min=Minimum; N=Number of participants 
in the population; n=Number of observations; PK=Pharmacokinetic(s); SD=Standard deviation; ‘-’=Not calculated 
Note: BLQ values were entered as zero for the determination of summary statistics with the exception of geometric mean, geometric SD, and geometric CV%, 
where BLQ values were imputed as half the lower limit of quantification (LLOQ) value. The LLOQ for rabeprazole was 0.5 ng/mL. 
 
Data Source: Listing 16.2.6.1-2 
 
 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 36 of 169 
 
Table 14.3.1-1.1 Overall Summary of TEAEs (Safety Population) - Part 1 
Category 
Statistic 
Camlipixant[b] 
(N=xx) 
Rifampin[c] 
(N=xx) 
Camlipixant + Rifampin[d] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
Study drug-related[a] TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
Severe TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
Serious TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
TEAEs leading to discontinuation 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
TEAEs leading to death 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
Abbreviations: E=Event; N=Number of participants in the population; n (%)=Number and percent of participants with TEAEs; TEAE=Treatment-emergent 
adverse event  
[a] Study drug-related events are events to which the relationship is categorized as "Definite", "Probable", or "Possible" 
[b] Attributed from Day 1 post-dose until Day 4 pre-dose of rifampin 
[c] Attributed from Day 4 dosing until Day 11 pre-dose of camlipixant 
[d] Attributed from camlipixant dosing on Day 11 until end of study 
Note: Each participant contributes once to each of the incidence rates, regardless of the number of occurrences. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
from Day 4 to Day 10, rifampin 
mg 
 from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
 
Data Source: Listing 16.2.7.2-1 and Listing 16.2.7.3-1 
 
 
 
 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
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Table 14.3.1-1.2 Overall Summary of TEAEs (Safety Population) - Part 2 
Category 
Statistic 
Camlipixant[b] 
(N=xx) 
Rabeprazole [c] 
(N=xx) 
Camlipixant + Rabeprazole 
[d] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
Study drug-related[a] TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
Severe TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
Serious TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
TEAEs leading to discontinuation 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
TEAEs leading to death 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
Abbreviations: E=Event; N=Number of participants in the population; n (%)=Number and percent of participants with TEAEs; TEAE=Treatment-emergent 
adverse event  
[a] Study drug-related events are events to which the relationship is categorized as "Definite", "Probable", or "Possible" 
[b] Attributed from Day 1 post-dose until Day 4 pre-dose of rabeprazole 
[c] Attributed from Day 4 dosing until Day 10 pre-dose of camlipixant 
[d] Attributed from camlipixant dosing on Day 10 until end of study 
Note: Each participant contributes once to each of the incidence rates, regardless of the number of occurrences. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
 mg 
from Day 4 to Day 9, rabeprazole 
mg 
 from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
 
Data Source: Listing 16.2.7.2-2 and Listing 16.2.7.3-2 
 
 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
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Table 14.3.1-2.1 TEAEs by SOC and PT (Safety Population) - Part 1 
MedDRA® System Organ Class 
   MedDRA® Preferred Term 
Statistic 
Camlipixant[a] 
(N=xx) 
Rifampin[b] 
(N=xx) 
Camlipixant + 
Rifampin[c] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; PT=Preferred term; SOC=System organ class; TEAE=Treatment-emergent adverse event   
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rifampin 
[b] Attributed from Day 4 dosing until Day 11 pre-dose of camlipixant 
[c] Attributed from camlipixant dosing on Day 11 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
from Day 4 to Day 10, rifampin 
 mg 
 from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
Adverse events were coded using MedDRA version X.X. 
 
Data Source: Listing 16.2.7.2-1 
 
Programming Notes: 
1) SOC will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 39 of 169 
 
Table 14.3.1-2.2 TEAEs by SOC and PT (Safety Population) - Part 2 
MedDRA® System Organ Class 
   MedDRA Preferred Term 
Statistic 
Camlipixant[a] 
(N=xx) 
Rabeprazole[b] 
(N=xx) 
Camlipixant + 
Rabeprazole[c] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; PT=Preferred term; SOC=System organ class; TEAE=Treatment-emergent adverse event 
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rabeprazole 
[b] Attributed from Day 4 dosing until Day 10 pre-dose of camlipixant 
[c] Attributed from camlipixant dosing on Day 10 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
 from Day 4 to Day 9, rabeprazole 
mg 
from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
Adverse events were coded using MedDRA version X.X. 
 
Data Source: Listing 16.2.7.2-2 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 40 of 169 
 
Table 14.3.1-3.1 TEAEs by Severity (Safety Population) - Part 1 
MedDRA® System Organ Class 
   MedDRA Preferred Term 
      Severity 
Statistic 
Camlipixant[a] 
(N=xx) 
Rifampin[b] 
(N=xx) 
Camlipixant + 
Rifampin[c] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
All TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Mild 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Moderate 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Severe 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Mild 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Moderate 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Severe 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Mild 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Moderate 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Severe 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; TEAE=Treatment-emergent adverse event 
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rifampin 
[b] Attributed from Day 4 dosing until Day 11 pre-dose of camlipixant 
[c] Attributed from camlipixant dosing on Day 11 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences using the highest reported severity. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
 from Day 4 to Day 10, rifampin 
mg 
from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
Adverse events were coded using MedDRA version X.X. 
 
Data Source: Listing 16.2.7.2-1 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
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Page 41 of 169 
 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 42 of 169 
 
Table 14.3.1-3.2 TEAEs by Severity (Safety Population) - Part 2 
MedDRA® System Organ Class 
   MedDRA Preferred Term 
      Severity 
Statistic 
Camlipixant[a] 
(N=xx) 
Rabeprazole[b] 
(N=xx) 
Camlipixant + 
Rabeprazole[c] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
All TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Mild 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Moderate 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Severe 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Mild 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Moderate 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Severe 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Mild 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Moderate 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Severe 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; TEAE=Treatment-emergent adverse event 
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rabeprazole 
[b] Attributed from Day 4 dosing until Day 10 pre-dose of camlipixant 
[c] Attributed from camlipixant dosing on Day 10 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences using the highest reported severity. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
 from Day 4 to Day 9, rabeprazole 
mg 
from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
Adverse events were coded using MedDRA version X.X. 
 
Data Source: Listing 16.2.7.2-2 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
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2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 44 of 169 
 
Table 14.3.1-4.1 TEAEs by Relationship to Study Drug (Camlipixant) (Safety Population) - Part 1 
 
 
Relationship to Camlipixant   
MedDRA® System Organ Class 
   MedDRA  Preferred Term  
       Relationship      
Statistic 
Camlipixant[a] 
(N=xx) 
Camlipixant + 
Rifampin[b] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
All TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; TEAE=Treatment-emergent adverse event 
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rifampin 
[b] Attributed from camlipixant dosing on Day 11 until end of study  
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences using the worst reported relationship. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
 mg 
from Day 4 to Day 10, rifampin 
 mg
 from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
Adverse events were coded using MedDRA version X.X. 
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Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 45 of 169 
 
 
Data Source: Listing 16.2.7.2-1 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 46 of 169 
 
Table 14.3.1-4.2 TEAEs by Relationship to Study Drug (Rifampin) (Safety Population) – Part 1 
 
 
Relationship to Rifampin 
MedDRA® System Organ Class 
   MedDRA  Preferred Term      
       Relationship  
Statistic 
Rifampin[a]  
(N=xx) 
Camlipixant + 
Rifampin[b] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
All TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; TEAE=Treatment-emergent adverse event 
[a] Attributed from Day 4 dosing until Day 11 pre-dose of camlipixant 
[b] Attributed from camlipixant dosing on Day 11 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences using the worst reported relationship. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
 from Day 4 to Day 10, rifampin 
mg 
from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
Adverse events were coded using MedDRA version X.X. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 47 of 169 
 
 
Data Source: Listing 16.2.7.2-1 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 48 of 169 
 
Table 14.3.1-4.3 TEAEs by Relationship to Study Drug (Camlipixant) (Safety Population) - Part 2 
 
 
Relationship to Camlipixant   
MedDRA® System Organ Class 
   MedDRA  Preferred Term  
      Relationship      
Statistic 
Camlipixant[a] 
(N=xx) 
Camlipixant + 
Rabeprazole[b] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
All TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; TEAE=Treatment-emergent adverse event 
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rabeprazole 
[b] Attributed from camlipixant dosing on Day 10 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences using the worst reported relationship. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
from Day 4 to Day 9, rabeprazole 
mg 
 from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
Adverse events were coded using MedDRA version X.X. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 49 of 169 
 
 
Data Source: Listing 16.2.7.2-2 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 50 of 169 
 
Table 14.3.1-4.4 TEAEs by Relationship to Study Drug (Rabeprazole) (Safety Population) - Part 2 
 
 
Relationship to Rabeprazole 
MedDRA® System Organ Class 
   MedDRA  Preferred Term       
       Relationship 
Statistic 
Rabeprazole[a]  
(N=xx) 
Camlipixant + 
Rabeprazole[b] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
All TEAEs 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Definite 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Probable 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Possible 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Unlikely 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
      Not Related 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; TEAE=Treatment-emergent adverse event 
[a] Attributed from Day 4 dosing until Day 10 pre-dose of camlipixant 
[b] Attributed from camlipixant dosing on Day 10 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences using the worst reported relationship. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
from Day 4 to Day 9, rabeprazole 
mg 
 from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
Adverse events were coded using MedDRA version X.X. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 51 of 169 
 
 
Data Source: Listing 16.2.7.2-2 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 52 of 169 
 
Table 14.3.1-5.1 Serious TEAEs (Safety Population) - Part 1 
MedDRA® System Organ Class 
   MedDRA Preferred Term 
Statistic 
Camlipixant[a] 
(N=xx) 
Rifampin[b] 
(N=xx) 
Camlipixant + 
Rifampin[c] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; TEAE=Treatment-emergent adverse event 
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rifampin 
[b] Attributed from Day 4 dosing until Day 11 pre-dose of camlipixant 
[c] Attributed from camlipixant dosing on Day 11 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
 from Day 4 to Day 10, rifampin 
mg 
from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
Adverse events were coded using MedDRA version X.X. 
 
Data Source: Listing 16.2.7.3-1 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 53 of 169 
 
Table 14.3.1-5.2 Serious TEAEs (Safety Population) – Part 2 
MedDRA® System Organ Class 
   MedDRA Preferred Term 
Statistic 
Camlipixant[a] 
(N=xx) 
Rabeprazole[b] 
(N=xx) 
Camlipixant + 
Rabeprazole[c] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the population; n (%)=Number and percent of 
participants with TEAEs; TEAE=Treatment-emergent adverse event  
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rabeprazole 
[b] Attributed from Day 4 dosing until Day 10 pre-dose of camlipixant 
[c] Attributed from camlipixant dosing on Day 10 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
from Day 4 to Day 9, rabeprazole 
mg 
 from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
Adverse events were coded using MedDRA version X.X. 
 
Data Source: Listing 16.2.7.3-2 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 54 of 169 
 
Table 14.3.1-6.1 Treatment-emergent AEMIs (Safety Population) - Part 1 
MedDRA® System Organ Class 
   MedDRA Preferred Term 
Statistic 
Camlipixant[a] 
(N=xx) 
Rifampin[b] 
(N=xx) 
Camlipixant + 
Rifampin[c] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AEMI=Adverse events of medical interest; E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the 
population; n (%)=Number and percent of participants with TEAEs 
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rifampin 
[b] Attributed from Day 4 dosing until Day 11 pre-dose of camlipixant 
[c] Attributed from camlipixant dosing on Day 11 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
 mg 
from Day 4 to Day 10, rifampin 
mg 
from Day 11 to 12 with co-
administration of camlipixant 50 mg SD on Day 11. 
Adverse events were coded using MedDRA version X.X. 
 
Data Source: Listing 16.2.7.4-1 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 55 of 169 
 
Table 14.3.1-6.2 Treatment-emergent AEMIs (Safety Population) - Part 2 
MedDRA® System Organ Class 
   MedDRA Preferred Term 
Statistic 
Camlipixant[a] 
(N=xx) 
Rabeprazole[b] 
(N=xx) 
Camlipixant + 
Rabeprazole[c] 
(N=xx) 
Overall 
(N=xx) 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
SOC 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 1 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
   PT 2 
n (%) E 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
x ( xx.x) x 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AEMI=Adverse events of medical interest; E=Event; MedDRA=Medical Dictionary for Regulatory Activities; N=Number of participants in the 
population; n (%)=Number and percent of participants with TEAEs  
[a] Attributed from Day 1 post-dose until Day 4 pre-dose of rabeprazole 
[b] Attributed from Day 4 dosing until Day 10 pre-dose of camlipixant 
[c] Attributed from camlipixant dosing on Day 10 until end of study 
Note: Each participant could only contribute once to each of the incidence rates within a system organ class and within a preferred term, regardless of the number 
of occurrences. 
The overall column includes participants from all treatment groups. 
Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
from Day 4 to Day 9, rabeprazole 
mg
 from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
Adverse events were coded using MedDRA version X.X. 
 
Data Source: Listing 16.2.7.4-2 
 
Programming Notes: 
1) SOCs will be presented in descending order of overall incidence rate in terms of frequency of subjects and then in frequency of events (alphabetical order will 
be used in case of equal rates). For each SOC, PT will be presented the same way. 
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
4) In the footnote, replace “X.X” with the actual MedDRA version used in the study.
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 56 of 169 
 
Table 14.3.4-1.1 Biochemistry (Safety Population) - Part 1 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx)  
xxx-xxx 
 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.1-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 57 of 169 
 
Table 14.3.4-1.2 Biochemistry (Safety Population) - Part 2 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.1-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 58 of 169 
 
Table 14.3.4-2.1 Biochemistry Shifts from Baseline (Safety Population) - Part 1 
 
 
 
Post Baseline 
 
 
Parameter (unit) 
Study Day 
Baseline  
Low  
n (%) 
Normal 
n (%) 
High 
n (%) 
 
 
 
 
 
 
xxxxxxx (xx)    
Day x 
Low 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
High 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: n (%)=Number and percentage of participants  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.1-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 59 of 169 
 
Table 14.3.4-2.2 Biochemistry Shifts from Baseline (Safety Population) - Part 2 
 
 
 
Post Baseline 
 
 
Parameter (unit)    
Study Day 
Baseline  
Low  
n (%) 
Normal 
n (%) 
High 
n (%) 
 
 
 
 
 
 
xxxxxxx (xx)    
Day x 
Low 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
High 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: n (%)=Number and percentage of participants  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.1-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 60 of 169 
 
Table 14.3.4-3.1 Hematology (Safety Population) - Part 1 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.2-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 61 of 169 
 
Table 14.3.4-3.2 Hematology (Safety Population) - Part 2 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.2-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 62 of 169 
 
Table 14.3.4-4.1 Hematology Shifts from Baseline (Safety Population) - Part 1 
 
 
 
Post Baseline  
 
 
Parameter (unit)    
Study Day 
Baseline  
Low  
n (%) 
Normal 
n (%) 
High 
n (%) 
 
 
 
 
 
 
xxxxxxx (xx)    
Day x 
Low 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
High 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: n (%)=Number and percentage of participants  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.2-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all treatment groups. 
a. 
Start a new page for each treatment group.  
3) Present all scheduled post-baseline visits. 
4) Present all parameters. 
5) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 63 of 169 
 
Table 14.3.4-4.2 Hematology Shifts from Baseline (Safety Population) - Part 2 
 
 
 
Post Baseline  
 
 
Parameter (unit)    
Study Day 
Baseline  
Low  
n (%) 
Normal 
n (%) 
High 
n (%) 
 
 
 
 
 
 
xxxxxxx (xx)    
Day x 
Low 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
High 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: n (%)=Number and percentage of participants  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.2-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 64 of 169 
 
Table 14.3.4-5.1 Coagulation (Safety Population) - Part 1 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.3-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 65 of 169 
 
Table 14.3.4-5.2 Coagulation (Safety Population) - Part 2 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.3-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 66 of 169 
 
Table 14.3.4-6.1 Coagulation Shifts from Baseline (Safety Population) - Part 1 
 
 
 
Post Baseline  
 
 
Parameter (unit)    
Study Day 
Baseline  
Low  
n (%) 
Normal 
n (%) 
High 
n (%) 
 
 
 
 
 
 
xxxxxxx (xx)   
Day x 
Low 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
High 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: n (%)=Number and percentage of participants  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.3-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 67 of 169 
 
Table 14.3.4-6.2 Coagulation Shifts from Baseline (Safety Population) - Part 2 
 
 
 
Post Baseline  
 
 
Parameter (unit)    
Study Day 
Baseline  
Low  
n (%) 
Normal 
n (%) 
High 
n (%) 
 
 
 
 
 
 
xxxxxxx (xx)    
Day x 
Low 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
High 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: n (%)=Number and percentage of participants  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.3-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 68 of 169 
 
Table 14.3.4-7.1 Urinalysis: Quantitative (Safety Population) - Part 1 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.4-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 69 of 169 
 
Table 14.3.4-7.2 Urinalysis: Quantitative (Safety Population) - Part 2 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.4-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 70 of 169 
 
Table 14.3.4-8.1 Urinalysis: Quantitative Shifts from Baseline (Safety Population) - Part 1 
 
 
 
Post Baseline  
 
 
Parameter (unit)    
Study Day 
Baseline  
Low  
n (%) 
Normal 
n (%) 
High 
n (%) 
 
 
 
 
 
 
xxxxxxx (xx)    
Day x 
Low 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
High 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: n (%)=Number and percentage of participants  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.4-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 71 of 169 
 
Table 14.3.4-8.2 Urinalysis: Quantitative Shifts from Baseline (Safety Population) - Part 2 
 
 
 
Post Baseline  
 
 
Parameter (unit)    
Study Day 
Baseline  
Low  
n (%) 
Normal 
n (%) 
High 
n (%) 
 
 
 
 
 
 
xxxxxxx (xx)    
Day x 
Low 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
High 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: n (%)=Number and percentage of participants 
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.4-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 72 of 169 
 
Table 14.3.4-9.1 Urinalysis: Categorical (Safety Population) - Part 1 
Parameter (unit) 
    
Study Day 
Result 
Overall 
(N=xx) 
n (%) 
xxxxxxx (xx) 
 
Day x (Baseline) 
Negative 
x ( xx.x) 
 
 
Trace 
x ( xx.x) 
 
 
 
 
 
Day x  
Negative 
x ( xx.x) 
 
 
Trace 
x ( xx.x) 
 
 
 
 
... 
 
 
 
 
 
 
 
Abbreviations: N=Number of participants in the population; n (%)=Number and percentage of participants 
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
 
Data Source: Listing 16.2.8.5-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present categorical parameters. 
a. 
Start a new page for each categorical parameter.  
3) Present all scheduled post-baseline visits. 
4) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 73 of 169 
 
Table 14.3.4-9.2 Urinalysis: Categorical (Safety Population) - Part 2 
Parameter (unit) 
    
Study Day 
Result 
Overall 
(N=xx) 
n (%) 
xxxxxxx (xx) 
Day x (Baseline) 
Negative 
x ( xx.x) 
 
 
Trace 
x ( xx.x) 
 
 
 
 
 
Day x  
Negative 
x ( xx.x) 
 
 
Trace 
x ( xx.x) 
 
 
 
 
... 
 
 
 
 
 
 
 
Abbreviations: N=Number of participants in the population; n (%)=Number and percentage of participants 
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
 
Data Source: Listing 16.2.8.5-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present categorical parameters. 
a. 
Start a new page for each categorical parameter.  
3) Present all scheduled post-baseline visits. 
4) Add abbreviations used in the table to the footnotes. 
 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 74 of 169 
 
Table 14.3.4-10.1 Vital Signs (Safety Population) - Part 1 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.6-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 75 of 169 
 
Table 14.3.4-10.2 Vital Signs (Safety Population) - Part 2 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
xxx-xxx 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.6-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 76 of 169 
 
Table 14.3.4-11.1 Vital Signs Shifts from Baseline (Safety Population) - Part 1 
 
 
 
Post Baseline  
 
 
 
Parameter (unit) 
Study Day 
 Baseline  
Normal  
n (%) 
Abnormal NCS 
 n (%) 
Abnormal CS 
n (%) 
Missing 
n(%) 
 
 
 
 
 
 
 
xxxxxxx (xx)  
Day x 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Abnormal NCS 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Abnormal CS 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Missing 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; n (%)=Number and percentage of participants; NCS=Not clinically 
significant  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.6-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 77 of 169 
 
Table 14.3.4-11.2 Vital Signs Shifts from Baseline (Safety Population) - Part 2 
 
 
 
Post Baseline  
Parameter (unit) 
Study Day 
Baseline  
Normal  
n (%) 
Abnormal NCS 
 n (%) 
Abnormal CS 
n (%) 
Missing 
n(%) 
 
 
 
 
 
 
 
xxxxxxx (xx) 
Day x 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Abnormal NCS 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Abnormal CS 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
Missing 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; n (%)=Number and percentage of participants; NCS=Not clinically 
significant  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.6-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 78 of 169 
 
Table 14.3.4-12.1 ECGs: Quantitative (Safety Population) - Part 1 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
 
xxx-xxx 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.7-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 79 of 169 
 
Table 14.3.4-12.2 ECGs: Quantitative (Safety Population) - Part 2 
Parameter (unit) 
Normal Range 
  Study Day 
    Statistic 
Overall 
(N=xx) 
 
 
xxxxxxx (xx) 
 
xxx-xxx 
 
 
    Day x (Baseline)  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x  
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
  Day x - CFB 
 
    n 
xx 
    Mean 
xx.x 
    SD 
xx.xx 
    Min 
xx.x 
    Median 
xx.x 
    Max 
xx.x 
 
 
… 
 
 
 
Abbreviations: CFB=Change from baseline; max=Maximum; min=Minimum; N=Number of participants in the 
population; n=Number of observations; SD=Standard deviation  
Note: Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug 
administration on Day 1. 
 
Data Source: Listing 16.2.8.7-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all parameters. 
a. 
Start a new page for each parameter.  
3) Present all scheduled visits. 
4) Independently for each parameter, if the baseline assessment for all subjects is on the same study day, identify 
the study day with “(Baseline)” [e.g., Day 1 (Baseline)]. Otherwise, the baseline would have to be summarized 
separately and identified as “Baseline”. 
5) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 80 of 169 
 
Table 14.3.4-13.1 ECGs: Interpretation Shifts from Baseline (Safety Population) - Part 1 
 
 
Post Baseline  
 
 
 
Study Day 
Baseline  
Normal  
n (%) 
Abnormal NCS 
 n (%) 
Abnormal CS 
n (%) 
Missing 
n (%) 
 
 
 
 
 
 
Day x 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
Abnormal NCS 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
Abnormal CS 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
Missing 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; n (%)=Number and percentage of participants; NCS=Not clinically 
significant;  
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
Data Source: Listing 16.2.8.7-1 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 81 of 169 
 
Table 14.3.4-13.2 ECGs: Interpretation Shifts from Baseline (Safety Population) - Part 2 
 
 
Post Baseline  
 
 
 
Study Day 
Baseline  
Normal  
n (%) 
Abnormal NCS 
 n (%) 
Abnormal CS 
n (%) 
Missing 
n (%) 
 
 
 
 
 
 
Day x 
Normal 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
Abnormal NCS 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
Abnormal CS 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
Missing 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
x ( xx.x) 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; n (%)=Number and percentage of participants; NCS=Not clinically 
significant 
Note: Percentages are based on the number of participants having available results at baseline and at post-baseline. 
Baseline is defined as the last result (scheduled or unscheduled) obtained prior to first study drug administration on 
Day 1. 
 
Data Source: Listing 16.2.8.7-2 
 
Programming Notes: 
1) Sort by parameter, in alphabetical order, and study day, in chronological order.  
2) Present all scheduled post-baseline visits. 
3) Present all parameters. 
4) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 82 of 169 
 
2.  
Figures
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 83 of 169 
 
Figure 14.2-14.1 Individual Plasma Concentrations of Camlipixant - Linear Scale (PK Concentration Population) - Part 1 
 
Plots of individual plasma concentrations over time, by treatment group for each participant. 
 
 
Figure Description: The individual plasma concentrations over time will be presented by treatment group (or day) for each participant. The figure will display values for 
all treatment groups for a particular participant on a single page. Straight lines will connect the values for each treatment (or day). Different symbols, colors and line types 
will be used to distinguish between each treatment (or day). 
 
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Actual Timepoint (Hours) 
Y axis title : Concentration (units) 
 
Abbreviations: PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-1 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints.  
2) Provide for each subject.  
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 84 of 169 
 
Figure 14.2-14.2 Individual Plasma Concentrations of Camlipixant – Linear Scale (PK Concentration Population) – Part 2 
 
Plots of individual plasma concentrations over time, by treatment group for each participant. 
 
 
Figure Description: The individual plasma concentrations over time will be presented by treatment group (or day) for each participant. The figure will display values for 
all treatment groups for a particular participant on a single page. Straight lines will connect the values for each treatment (or day). Different symbols, colors and line types 
will be used to distinguish between each treatment (or day). 
 
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units. 
 
X axis title:  Actual Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-2 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
2) Provide for each subject. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 85 of 169 
 
Figure 14.2-15.1 Individual Plasma Concentrations of Camlipixant - Semi-Log Scale (PK Concentration Population) - Part 1 
 
Plots of individual plasma concentrations (log scale) over time, by treatment group for each participant. 
 
 
Figure Description: The individual plasma concentrations (log scale) over time will be presented by treatment group (or day) for each participant. The figure will display 
values for all treatment groups for a particular participant on a single page. Straight lines will connect the values for each treatment (or day). Different symbols, colors and 
line types will be used to distinguish between each treatment (or day). 
 
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Actual Timepoint (Hours)  
Y axis title : Concentration (units) 
 
Abbreviations: PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-1 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
2) Provide for each subject. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 86 of 169 
 
Figure 14.2-15.2 Individual Plasma Concentrations of Camlipixant – Semi-Log Scale (PK Concentration Population) – Part 2 
 
Plots of individual plasma concentrations (log scale) over time, by treatment group for each participant. 
 
 
Figure Description: The individual plasma concentrations (log scale) over time will be presented by treatment group (or day) for each participant. The figure will display 
values for all treatment groups for a particular participant on a single page. Straight lines will connect the values for each treatment (or day). Different symbols, colors and 
line types will be used to distinguish between each treatment (or day). 
 
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Actual Timepoint (Hours)  
Y axis title: Concentration (units) 
 
Abbreviations: PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-2 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
2) Provide for each subject. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 87 of 169 
 
Figure 14.2-16.1 Mean (±SD) Plasma Concentrations of Camlipixant - Linear Scale (PK Concentration Population) - Part 1 
 
Plot of mean plasma concentrations over time 
 
 
Figure Description: The mean plasma concentration over time (±SD) will be presented. The figure will display values for all treatment groups on a single page. Straight 
lines will connect the values within each treatment group. Different symbols, colors and line types will be used to distinguish between each treatment group. The SD at 
each point will be added. 
 
For each figure, the X axis will be the scheduled (nominal) timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Nominal Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: SD= standard deviation; PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-1 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 88 of 169 
 
Figure 14.2-16.2 Mean (±SD) Plasma Concentrations of Camlipixant - Linear Scale (PK Concentration Population) - Part 2 
 
Plot of mean plasma concentrations over time 
 
 
Figure Description: The mean plasma concentration over time (±SD) will be presented. The figure will display values for all treatment groups on a single page. Straight 
lines will connect the values within each treatment group. Different symbols, colors and line types will be used to distinguish between each treatment group. The SD at 
each point will be added. 
 
For each figure, the X axis will be the scheduled (nominal) timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Nominal Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: SD= standard deviation; PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-2 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 89 of 169 
 
Figure 14.2-17.1 Mean (±SD) Plasma Concentrations of Camlipixant - Semi-Log Scale (PK Concentration Population) - Part 1 
 
Plot of mean plasma concentrations (log scale) over time 
 
 
Figure Description: The mean plasma concentrations (log scale) over time will be presented. The figure will display values for all treatment groups on a single page. 
Straight lines will connect the values within each treatment group. Different symbols, colors and line types will be used to distinguish between each treatment group. 
 
For each figure, the X axis will be the scheduled (nominal) timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Nominal Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: SD= standard deviation; PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-1 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listin
us Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 90 of 169 
 
Figure 14.2-17.2 Mean (±SD) Plasma Concentrations of Camlipixant - Semi-Log Scale (PK Concentration Population) - Part 2 
 
Plot of mean plasma concentrations (log scale) over time 
 
 
Figure Description: The mean plasma concentrations (log scale) over time will be presented. The figure will display values for all treatment groups on a single page. 
Straight lines will connect the values within each treatment group. Different symbols, colors and line types will be used to distinguish between each treatment group. 
 
For each figure, the X axis will be the scheduled (nominal) timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Nominal Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: SD= standard deviation; PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-2 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
 
 
 
 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 91 of 169 
 
Figure 14.2-18.1 Overlay of Individual Plasma Concentrations of Camlipixant - Linear Scale (PK Concentration Population) - Part 1 
 
Plots of overlay individual plasma concentrations over time for all participants, by treatment group. 
 
 
Figure Description: The individual plasma concentrations over time will be presented for all participants, by treatment group. The figure will display values for all 
participants within each treatment group on a single page. Straight lines will connect the values for each participant.  
 
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Actual Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-1 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints.  
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 92 of 169 
 
Figure 14.2-18.2 Overlay of Individual Plasma Concentrations of Camlipixant – Linear Scale (PK Concentration Population) – Part 2 
 
Plots of overlay individual plasma concentrations over time for all participants, by treatment group. 
 
 
Figure Description: The individual plasma concentrations over time will be presented for all participant, by treatment group. The figure will display values for all 
participants within each treatment group on a single page. Straight lines will connect the values for each participant.  
 
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units. 
 
X axis title:  Actual Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-2 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 93 of 169 
 
Figure 14.2-19.1 Overlay of Individual Plasma Concentrations of Camlipixant – Semi-Log Scale (PK Concentration Population) - 
Part 1 
 
Plots of overlay individual plasma concentrations (log scale) over time for all participants, by treatment group. 
 
 
Figure Description: The individual plasma concentrations (log scale) over time will be presented for allparticipant, by treatment group. The figure will display values for 
all participant within each treatment group on a single page. Straight lines will connect the values for each participant.  
 
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units. 
 
X axis title: Actual Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-1 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints.  
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 94 of 169 
 
Figure 14.2-19.2 Overlay of Individual Plasma Concentrations of Camlipixant – Semi-Log Scale (PK Concentration Population) – 
Part 2 
 
Plots of overlay individual plasma concentrations (log scale) over time for all participants, by treatment group. 
 
 
Figure Description: The individual plasma concentrations (log scale) over time will be presented for allparticipant, by treatment group. The figure will display values for 
all participants within each treatment group on a single page. Straight lines will connect the values for each participant.  
 
For each figure, the X axis will be the actual timepoint. The Y axis will be the concentration, in units. 
 
X axis title:  Actual Timepoint (Hours) 
Y axis title: Concentration (units) 
 
Abbreviations: PK= pharmacokinetic(s) 
 
Data Source: Listing 16.2.6.1-2 
 
 
Programming Notes:  
1) Include all scheduled visits/timepoints. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 95 of 169 
 
3. Listings 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 96 of 169 
Sep 
Listing 16.1.9-1 
Output: Assessment of Rifampin Effect: DDI by ANOVA (PK Parameter Population) - Part 1 
 
outputs related to the Assessment of Rifampin Effect: DDI by ANOVA will be placed here. 
 
Abbreviations: DDI=Drug-drug interaction; ANOVA=Analysis of variance 
 
CCI
CCI
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 97 of 169 
Sep 
Listing 16.1.9-2 
 Output: Assessment of Rabeprazole Effect: DDI by ANOVA (PK Parameter Population) - Part 2 
 
 outputs related to the Assessment of Rabeprazole Effect: DDI by ANOVA will be placed here. 
 
Abbreviations: DDI=Drug-drug interaction; ANOVA=Analysis of variance 
 
CCI
CCI
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 98 of 169 
Sep 
Listing 16.1.9-3
 Output: Non-Parametric Assessment of Rifampin Effect (PK Parameter Population) - Part 1 
 
outputs related to the Non-Parametric Assessment of Rifampin Effect will be placed here. 
 
Abbreviations:  
 
CCI
CCI
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 99 of 169 
Sep 
Listing 16.1.9-4 
 Output: Non-Parametric Assessment of Rabeprazole Effect (PK Parameter Population) - Part 2 
 
outputs related to the Non-Parametric Assessment of Rabeprazole Effect will be placed here. 
 
Abbreviations:  
 
CCI
CCI
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 100 of 169 
Sep 
Listing 16.2.1.1-1 Subject Enrollment (Safety Population) - Part 1 
Subject 
Number 
Date / Time 
ICF Signed 
ICF Version Date / 
Version Number 
Protocol 
Version 
Number 
Did the Subject Reconsent? / 
If Yes, Date / Time of 
Reconsent 
ICF Version 
Number at Time 
of Reconsent 
Protocol Version 
Number at Time 
of Reconsent 
Was there a new 
addendum to the ICF? / 
If Yes, Date / Time 
Addendum Signed 
Addendum 
Version Date / 
Version Number 
 
 
 
 
 
 
 
 
 
xxxxx 
ddmmmyyyy / 
hh:mm 
ddmmmyyyy / xx 
xx 
Yes / 
ddmmmyyyy / hh:mm 
xx  
xx  
Yes / 
ddmmmyyyy / hh:mm 
ddmmmyyyy / xx 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ICF=Informed consent form 
 
Programming Notes: 
1) Sort by subject number 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 101 of 169 
Sep 
Listing 16.2.1.1-2 Subject Enrollment (Safety Population) - Part 2 
Subject 
Number 
Date / Time 
ICF Signed 
ICF Version Date / 
Version Number 
Protocol 
Version 
Number 
Did the Subject Reconsent? / 
If Yes, Date / Time of 
Reconsent 
ICF Version 
Number at Time 
of Reconsent 
Protocol Version 
Number at Time 
of Reconsent 
Was there a new 
addendum to the ICF? / 
If Yes, Date / Time 
Addendum Signed 
Addendum 
Version Date / 
Version Number 
 
 
 
 
 
 
 
 
 
xxxxx 
ddmmmyyyy / 
hh:mm 
ddmmmyyyy / xx 
xx 
Yes / 
ddmmmyyyy / hh:mm 
xx  
xx  
Yes / 
ddmmmyyyy / hh:mm 
ddmmmyyyy / xx 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ICF=Informed consent form 
 
Programming Notes: 
1) Sort by subject number 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 102 of 169 
Sep 
Listing 16.2.1.2-1 Subject Disposition (Safety Population) - Part 1 
Subject Number 
Did the subject complete the study? / 
If No, Reason for Non-Completion 
Date of Withdrawal or Completion / 
Last Date of Participation or Contact 
Other Recorded Information 
 
 
 
 
xxxxx 
No / xxxxxxxxxxxxxxx 
ddmmmyyyy / ddmmmyyyy 
xxxxxxxxxxxxxxx 
 
 
 
 
xxxxx 
Yes 
ddmmmyyyy / ddmmmyyyy 
N/A 
 
 
 
 
… 
 
 
 
 
 
 
 
Abbreviations: N/A=Not applicable 
 
Programming Notes: 
1) Sort by subject number. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 103 of 169 
Sep 
Listing 16.2.1.2-2 Subject Disposition (Safety Population) - Part 2 
Subject Number 
Did the subject complete the study? / 
If No, Reason for Non-Completion 
Date of Withdrawal or Completion / 
Last Date of Participation or Contact 
Other Recorded Information 
 
 
 
 
xxxxx 
No / xxxxxxxxxxxxxxx 
ddmmmyyyy / ddmmmyyyy 
xxxxxxxxxxxxxxx 
 
 
 
 
xxxxx 
Yes 
ddmmmyyyy / ddmmmyyyy 
N/A 
 
 
 
 
… 
 
 
 
 
 
 
 
Abbreviations: N/A=Not applicable 
 
Programming Notes: 
1) Sort by subject number. 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 104 of 169 
Sep 
Listing 16.2.2.1-1 Protocol Deviations (Safety Population) - Part 1 
Subject 
Number 
Study Day 
Date of Deviation  
Deviation Category 
Deviation Classification[a]/ 
Importance[b] 
Description of Deviation 
 
 
 
 
 
 
xxxxx 
Day x 
ddmmmyyyy 
xxxxxxxxxxxxx 
Minor/ 
Non-important 
xxxxxxxxxxxxx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
[a] Critical, major or minor 
[b] Important or non-important as per ICH E3 definition 
 
Programming Notes: 
1) Sort by subject number and date of deviation. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 105 of 169 
Sep 
Listing 16.2.2.1-2 Protocol Deviations (Safety Population) - Part 2 
Subject 
Number 
Study Day 
Date of Deviation  
Deviation Category 
Deviation Classification[a]/ 
Importance[b] 
Description of Deviation 
 
 
 
 
 
 
xxxxx 
Day x 
ddmmmyyyy 
xxxxxxxxxxxxx 
Minor/ 
Non-important 
xxxxxxxxxxxxx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
[a] Critical, major or minor 
[b] Important or non-important as per ICH E3 definition 
 
Programming Notes: 
1) Sort by subject number and date of deviation. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 106 of 169 
Sep 
Listing 16.2.3.1-1 Inclusion and Exclusion Criteria (Safety Population) - Part 1 
Subject Number 
Study Day 
Assessment Date 
Did the subject meet all eligibility criteria? / If No, Criteria Not Met: 
Category / Criterion Short Name / Reason Criterion not Respected 
 
 
 
 
xxxxx 
Screening 
ddmmmyyyy 
Yes   
 
Day x 
ddmmmyyyy 
No / xxxxxxxx / xxxxxxxx / xxxxxxxx 
 
 
 
 
… 
 
 
 
 
 
 
 
 
Programming Notes: 
1) Sort by subject number and assessment date. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 107 of 169 
Sep 
Listing 16.2.3.1-2 Inclusion and Exclusion Criteria (Safety Population) - Part 2 
Subject Number 
Study Day 
Assessment Date 
Did the subject meet all eligibility criteria? / If No, Criteria Not Met: 
Category / Criterion Short Name / Reason Criterion not Respected 
 
 
 
 
xxxxx 
Screening 
ddmmmyyyy 
Yes   
 
Day x 
ddmmmyyyy 
No / xxxxxxxx / xxxxxxxx / xxxxxxxx 
 
 
 
 
… 
 
 
 
 
 
 
 
 
Programming Notes: 
1) Sort by subject number and assessment date. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 108 of 169 
Sep 
Listing 16.2.3.2-1 Assignment to Analysis Populations - Part 1 
Subject 
Number 
Date / Time of First Study 
Drug Administration 
Is the subject included 
in the safety population? / 
If No Reason 
Is the subject included in the 
PK concentration population? / 
If No Reason 
Is the subject included in the 
PK parameter population? / 
If No Reason 
Is the subject included in the 
pharmacogenomic population? / 
If No Reason 
 
 
 
 
 
 
xxxxx 
ddmmmyyyy / hh:mm 
Yes 
Yes 
Yes 
No / xxxxxxxxxxxxx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 109 of 169 
Sep 
Listing 16.2.3.2-2 Assignment to Analysis Populations - Part 2 
Subject 
Number 
Date / Time of First Study 
Drug Administration 
Is the subject included 
in the safety population? / 
If No Reason 
Is the subject included in the 
PK concentration population? / 
If No Reason 
Is the subject included in the 
PK parameter population? / 
If No Reason 
Is the subject included in the 
pharmacogenomic population? / 
If No Reason 
 
 
 
 
 
 
xxxxx 
ddmmmyyyy / hh:mm 
Yes 
Yes 
Yes 
No / xxxxxxxxxxxxx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 110 of 169 
Sep 
Listing 16.2.4.1-1 Demographics (Safety Population) - Part 1 
Subject 
Number 
Age 
(years)[a] 
Sex 
If female, is subject of 
childbearing potential? 
If Female of Non-Childbearing Potential, 
Reason for Non-Childbearing Potential 
Ethnicity 
Race 
 
 
 
 
 
 
 
xxxxx 
xx 
Female 
No 
Post-Menopause 
Not Hispanic or Latino 
Am Indian 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: Am Indian=American Indian or Alaskan native; Black=Black or African American; Hawaiian=Native Hawaiian or other pacific islander 
[a] Age at the time of informed consent 
 
 
Programming Notes: 
1) Sort by subject number. 
2) Refer to footnotes for additional instructions. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 111 of 169 
Sep 
Listing 16.2.4.1-2 Demographics (Safety Population) - Part 2 
Subject 
Number 
Age 
(years)[a] 
Sex 
If female, is subject of 
childbearing potential? 
If Female of Non-Childbearing Potential, 
Reason for Non-Childbearing Potential 
Ethnicity 
Race 
 
 
 
 
 
 
 
xxxxx 
xx 
Female 
No 
Post-Menopause 
Not Hispanic or Latino 
Am Indian 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: Am Indian=American Indian or Alaskan native; Black=Black or African American; Hawaiian=Native Hawaiian or other pacific islander 
[b] Age at the time of informed consent 
 
 
Programming Notes: 
1) Sort by subject number. 
2) Refer to footnotes for additional instructions. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 112 of 169 
Sep 
Listing 16.2.4.2-1 Body Measurements (Safety Population) - Part 1 
Subject Number 
Was the assessment performed? / 
If No, Reason 
Date / Time of Assessment 
Height (cm) 
Weight (kg) 
BMI (kg/m2) 
 
 
 
 
 
 
xxxxx 
Yes 
ddmmmyyyy / hh:mm 
xxxx 
xxxx 
xxxx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: BMI=Body mass index 
 
 
 
 
Programming Notes: 
1) Sort by subject number. 
2) Refer to footnotes for additional instructions. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 113 of 169 
Sep 
Listing 16.2.4.2-2 Body Measurements (Safety Population) - Part 2 
Subject Number 
Was the assessment performed? / 
If No, Reason 
Date / Time of Assessment 
Height (cm) 
Weight (kg) 
BMI (kg/m2) 
 
 
 
 
 
 
xxxxx 
Yes 
ddmmmyyyy / hh:mm 
xxxx 
xxxx 
xxxx 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: BMI=Body mass index 
 
 
 
 
Programming Notes: 
1) Sort by subject number. 
2) Refer to footnotes for additional instructions. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 114 of 169 
Sep 
Listing 16.2.4.3-1 Medical History (Safety Population) - Part 1 
Subject 
Number 
Collection 
Date 
Medical 
History 
ID 
Medical History Term 
MedDRA® System Organ Class / 
MedDRA Preferred Term 
Start Date / 
End Date 
Is the subject taking 
any medication related 
to this condition? 
 
 
 
 
 
 
 
xxxxx 
ddmmmyyyy 
x 
TERM 1 
SOC 1 / 
PT 1 
ddmmmyyyy / 
ddmmmyyyy 
No 
 
 
 
 
 
 
 
xxxxx 
ddmmmyyyy 
x 
TERM 2 
SOC 1 / 
PT 1 
ddmmmyyyy / 
ONGOING 
Yes 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ID= identifier; MedDRA= Medical Dictionary for Regulatory Activities; PT= preferred term; SOC= system organ class 
Note: Medical history terms were coded using MedDRA version X.X 
 
Programming Notes: 
1) Sort by subject number, start date, end date, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”.  
3) If finding is ongoing, replace end date with “ONGOING” (in uppercase). 
4) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
5) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
6) In the footnote, replace “X.X” with the actual MedDRA version used in the study 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 115 of 169 
Sep 
Listing 16.2.4.3-2 Medical History (Safety Population) - Part 2 
Subject 
Number 
Collection 
Date 
Medical 
History 
ID 
Medical History Term 
MedDRA® System Organ Class / 
MedDRA Preferred Term 
Start Date / 
End Date 
Is the subject taking 
any medication related 
to this condition? 
 
 
 
 
 
 
 
xxxxx 
ddmmmyyyy 
x 
TERM 1 
SOC 1 / 
PT 1 
ddmmmyyyy / 
ddmmmyyyy 
No 
 
 
 
 
 
 
 
xxxxx 
ddmmmyyyy 
x 
TERM 2 
SOC 1 / 
PT 1 
ddmmmyyyy / 
ONGOING 
Yes 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: ID= identifier; MedDRA= Medical Dictionary for Regulatory Activities; PT= preferred term; SOC= system organ class 
Note: Medical history terms were coded using MedDRA version X.X 
 
Programming Notes: 
1) Sort by subject number, start date, end date, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”.  
3) If finding is ongoing, replace end date with “ONGOING” (in uppercase). 
4) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
5) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
6) In the footnote, replace “X.X” with the actual MedDRA version used in the study 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 116 of 169 
Sep 
CCI
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 117 of 169 
Sep 
 
 
CCI
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 118 of 169 
Sep 
Listing 16.2.4.5-1 Prior and Concomitant Medications (Safety Population) - Part 1 
Subject 
Number 
Reported Name / 
ATC Classification / 
Preferred Name 
Indication 
Dose, Unit / Form 
Frequency / 
Route 
Start Date / Time / 
End Date / Time 
Due to AE ? / 
If Yes, AE ID(s) / 
Due to MH? / 
If Yes, MH ID(s) 
Prior or 
Concomitant 
 
 
 
 
 
 
 
 
xxxxx 
Medication 1 / 
ATC 1 / 
Preferred Name 1 / 
xxxxxxxxxxx 
100 mg / Tablet 
 / Oral 
ddmmmyyyy / 
hh:mm / 
ddmmmyyyy / hh:mm 
Yes / 1 /No  
Prior 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; ATC=Anatomic therapeutic chemical; ID=Identifier; MH=Medical history; WHODrug=World Health Organization Global Drug 
Dictionary. 
Note: Prior medications are defined as medications that start and stop prior to the first dose of study drug. All other medications will be defined as concomitant 
medications including those that start prior to the first dose of study drug and continue thereafter. 
Medications were coded using WHODrug, version MMM YYYY. 
 
Programming Notes: 
1) Sort by subject number, start date / time, and end date / time. 
2) If medication is ongoing, replace end date / time with “ONGOING” (in uppercase). 
3) If start or end time is unknown, replace time with “UNKNOWN” (in uppercase). 
4) In the footnote, replace “MMM YYYY” with the actual WHO DD version used in the study. 
5) Add abbreviations used in the table to the footnotes. 
a. 
 BID=Bis in die (twice daily); TID=Ter in die (three times daily); QID=Quater in die (four times daily) 
 
 
CCI
CCI
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 119 of 169 
Sep 
Listing 16.2.4.5-2 Prior and Concomitant Medications (Safety Population) - Part 2 
Subject 
Number 
Reported Name / 
ATC Classification / 
Preferred Name 
Indication 
Dose, Unit / Form 
Frequency / 
Route 
Start Date / Time / 
End Date / Time 
Due to AE ? / 
If Yes, AE ID(s) / 
Due to MH? / 
If Yes, MH ID(s) 
Prior or 
Concomitant 
 
 
 
 
 
 
 
 
xxxxx 
Medication 1 / 
ATC 1 / 
Preferred Name 1 / 
xxxxxxxxxxx 
100 mg / Tablet 
 / Oral 
ddmmmyyyy / 
hh:mm / 
ddmmmyyyy / hh:mm 
Yes / 1 /No  
Prior 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; ATC=Anatomic therapeutic chemical; ID=Identifier; MH=Medical history; WHODrug=World Health Organization Global Drug 
Dictionary. 
Note: Prior medications are defined as medications that start and stop prior to the first dose of study drug. All other medications will be defined as concomitant 
medications including those that start prior to the first dose of study drug and continue thereafter. 
Medications were coded using WHODrug, version MMM YYYY. 
 
Programming Notes: 
1) Sort by subject number, start date / time, and end date / time. 
2) If medication is ongoing, replace end date / time with “ONGOING” (in uppercase). 
3) If start or end time is unknown, replace time with “UNKNOWN” (in uppercase). 
4) In the footnote, replace “MMM YYYY” with the actual WHO DD version used in the study. 
5) Add abbreviations used in the table to the footnotes. 
a. 
 BID=Bis in die (twice daily); TID=Ter in die (three times daily); QID=Quater in die (four times daily) 
 
CCI
CCI
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 120 of 169 
Sep 
Listing 16.2.4.6-1 Urine Drug Screen (Safety Population) - Part 1 
Subject Number 
Study Day 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Result / If Positive, Test Name(s) 
 
 
 
 
 
xxxxx 
Screening 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Yes 
ddmmmyyyy / hh:mm 
Positive / MDMA 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: 
 
Programming Notes: 
1) Sort by subject number, and visit.  
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
a. 
MDMA=3,4 methylenedioxymethamphetamine, PCP=Phencyclidine; THC=Tetrahydrocannabinol 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 121 of 169 
Sep 
Listing 16.2.4.6-2 Urine Drug Screen (Safety Population) - Part 2 
Subject Number 
Study Day 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Result / If Positive, Test Name(s) 
 
 
 
 
 
xxxxx 
Screening 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Yes 
ddmmmyyyy / hh:mm 
Positive / MDMA 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: 
 
Programming Notes: 
1) Sort by subject number, and visit.  
2) Refer to footnotes for additional instructions. 
3) Add abbreviations used in the table to the footnotes. 
a. 
MDMA=3,4 methylenedioxymethamphetamine, PCP=Phencyclidine; THC=Tetrahydrocannabinol 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 122 of 169 
Sep 
Listing 16.2.4.7-1 Alcohol Breath Test (Safety Population) - Part 1 
Subject Number 
Study Day 
Was the test performed? / 
If No, Reason 
Date / Time of Collection 
Result 
 
 
 
 
 
xxxxx 
Screening 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Yes 
ddmmmyyyy / hh:mm 
Positive 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
Programming Notes: 
1) Sort by subject number, and visit.  
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 123 of 169 
Sep 
Listing 16.2.4.7-2 Alcohol Breath Test (Safety Population) - Part 2 
Subject Number 
Study Day 
Was the test performed? / 
If No, Reason 
Date / Time of Collection 
Result 
 
 
 
 
 
xxxxx 
Screening 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Yes 
ddmmmyyyy / hh:mm 
Positive 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
Programming Notes: 
1) Sort by subject number, and visit. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 124 of 169 
Sep 
Listing 16.2.4.8-1 Urine Cotinine Test (Safety Population) - Part 1 
Subject Number 
Study Day 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Result 
 
 
 
 
 
xxxxx 
Screening 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Yes 
 
Positive 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: 
 
Programming Notes: 
1) Sort by subject number, and visit. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 125 of 169 
Sep 
Listing 16.2.4.8-2 Urine Cotinine Test (Safety Population) - Part 2 
Subject Number 
Study Day 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Result 
 
 
 
 
 
xxxxx 
Screening 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Yes 
 
Positive 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: 
 
Programming Notes: 
1) Sort by subject number, and visit.  
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 126 of 169 
Sep 
Listing 16.2.4.9-1 Pregnancy Test (Safety Population) - Part 1 
Subject Number 
Study Day 
Sample Matrix[a] 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Result 
 
 
 
 
 
 
xxxxx 
Screening 
Urine 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Serum 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Urine 
 
ddmmmyyyy / hh:mm 
Positive 
… 
 
 
 
 
 
 
 
 
 
 
 
[a] Serum or urine 
 
Programming Notes: 
1) Sort by subject number, and visit.  
2) Include all visits. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 127 of 169 
Sep 
Listing 16.2.4.9-2 Pregnancy Test (Safety Population) - Part 2 
Subject Number 
Study Day 
Sample Matrix[a] 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Result 
 
 
 
 
 
 
xxxxx 
Screening 
Urine 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Serum 
Yes 
ddmmmyyyy / hh:mm 
Negative 
 
Day x 
Urine 
 
ddmmmyyyy / hh:mm 
Positive 
… 
 
 
 
 
 
 
 
 
 
 
 
[a] Serum or urine 
 
Programming Notes: 
1) Sort by subject number, and visit.  
2) Include all visits. 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 128 of 169 
Sep 
Listing 16.2.4.10-1 Follicle Stimulating Hormone Test (Safety Population) - Part 1 
Subject Number 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Result (mIU/mL) 
Normal Range 
 
 
 
 
 
xxxxx 
Yes 
ddmmmyyyy / hh:mm 
xxxx 
xxx-xxx 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
Programming Notes: 
1) Sort by subject number. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 129 of 169 
Sep 
Listing 16.2.4.10-2 Follicle Stimulating Hormone Test (Safety Population) - Part 2 
Subject Number 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Result (mIU/mL) 
Normal Range 
 
 
 
 
 
xxxxx 
Yes 
ddmmmyyyy / hh:mm 
xxxx 
xxx-xxx 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
Programming Notes: 
1) Sort by subject number.  
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 130 of 169 
Sep 
Listing 16.2.4.11-1 Serology (Safety Population) - Part 1 
Subject Number 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Are there any clinically significant values? / 
If Yes, Clinically Significant Lab Analyte(s) 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
xxxxx 
Yes 
ddmmmyyyy / hh:mm 
Yes / HBsAg 
N/A / 1 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; ID=Identifier; MH=Medical history 
 
Programming Notes: 
1) Sort by subject number.  
2) Add abbreviations used in the table to the footnotes: 
a. 
HIV=Immunodeficiency virus; HCV=Hepatitis C virus; HBsAg= Hepatitis B virus surface antigen 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 131 of 169 
Sep 
Listing 16.2.4.11-2 Serology (Safety Population) - Part 2 
Subject Number 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Are there any clinically significant values? / 
If Yes, Clinically Significant Lab Analyte(s) 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
xxxxx 
Yes 
ddmmmyyyy / hh:mm 
Yes / HBsAg 
N/A / 1 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; ID=Identifier; MH=Medical history 
 
Programming Notes: 
1) Sort by subject number.  
2) Add abbreviations used in the table to the footnotes: 
a. 
HIV=Immunodeficiency virus; HCV= Hepatitis C virus; HBsAg= Hepatitis B virus surface antigen 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 132 of 169 
Sep 
Listing 16.2.4.12-1 COVID-19 Test (Safety Population) - Part 1 
Subject 
Number 
Study Day 
Was the test performed? / 
If No, Reason 
Date / Time of Collection 
Method 
Result 
 
 
 
 
 
 
xxxxx 
Day x 
Yes 
ddmmmyyyy / hh:mm 
PCR 
Negative 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: COVID-19=Coronavirus 2019 
 
Programming Notes: 
1) Sort by subject number, and visit. 
2) Add abbreviations used in the table to the footnotes: 
a. 
PCR=Polymerase chain reaction 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 133 of 169 
Sep 
Listing 16.2.4.12-2 COVID-19 Test (Safety Population) - Part 2 
Subject 
Number 
Study Day 
Was the test performed? / 
If No, Reason 
Date / Time of Collection 
Method 
Result 
 
 
 
 
 
 
xxxxx 
Day x 
Yes 
ddmmmyyyy / hh:mm 
PCR 
Negative 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: COVID-19=Coronavirus 2019 
 
Programming Notes: 
1) Sort by subject number, and visit. 
2) Add abbreviations used in the table to the footnotes: 
a. 
PCR=Polymerase chain reaction 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 134 of 169 
Sep 
Listing 16.2.5.1-1 Study Drug Administration (Safety Population) - Part 1 
Subject 
Number 
Study Day 
Was the study drug administered? /  
If No, Reason 
Administration Date / Time 
Treatment Name 
Planned Dose (Unit) / 
Was the planned dose administered? / 
Dose Administered (Unit) 
 
 
 
 
 
 
xxxxx 
Day x 
Yes 
ddmmmyyyy / hh:mm 
 
Camlipixant 
xx (xx) / Yes / xx (xx) 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
 mg 
from Day 4 to Day 10, rifampin 
 mg 
 from Day 11 to 12 with co-administration 
of camlipixant 50 mg SD on Day 11. 
 
Programming Notes: 
1) Sort by subject number, and visit. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 135 of 169 
Sep 
Listing 16.2.5.1-2 Study Drug Administration (Safety Population) - Part 2 
Subject 
Number 
Study Day 
Was the study drug administered? /  
If No, Reason 
Administration Date / Time 
Treatment Name 
Planned Dose (Unit) / 
Was the planned dose administered? / 
Dose Administered (Unit) 
 
 
 
 
 
 
xxxxx 
Day x 
Yes 
ddmmmyyyy / hh:mm 
 
Camlipixant 
xx (xx) / Yes / xx (xx) 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
 from Day 4 to Day 9, rabeprazole 
mg 
from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
 
Programming Notes: 
1) Sort by subject number, and visit. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 136 of 169 
Sep 
Listing 16.2.6.1-1 Plasma PK Concentrations (PK Concentration Population) - Part 1 
 
Analyte 
Subject 
Number 
Study 
Day 
Nominal Timepoint 
(Hours) 
Date / Time of Study Drug Administration / 
Date / Time of Sample Collection 
Actual Time[a] 
(hours) 
Concentration 
(unit) 
Excluded? / 
If  Yes,  Reason 
 
 
 
 
 
 
 
 
Camlipixant xxxxx 
Day 1 
Pre-Dose  
ddmmmyyyy / hh:mm / 
ddmmmyyyy / hh:mm  
0.000 
xx xx 
Yes / Inconclusive 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: 
[a] Actual time is the difference (in hours) from study drug administration to sample collection. 
 
Programming Notes:  
1) add pre-dose concentrations of Rifampin also in this listing. 
2) Sort by analyte, subject number, day, and timepoint. 
3) Include all scheduled visits/timepoints. 
a. 
If a sample is not collected at a scheduled visit/timepoint, collection data is presented as "-". 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 137 of 169 
Sep 
Listing 16.2.6.1-2 Plasma PK Concentrations (PK Concentration Population) - Part 2 
 
Analyte 
Subject 
Number 
Study 
Day 
Nominal Timepoint 
(Hours) 
Date / Time of Study Drug Administration / 
Date / Time of Sample Collection 
Actual Time[a] 
(hours) 
Concentration 
(unit) 
Excluded? / 
If  Yes,  Reason 
 
 
 
 
 
 
 
 
Camlipixant xxxxx 
Day 1 
Pre-Dose  
ddmmmyyyy / hh:mm / 
ddmmmyyyy / hh:mm  
0.000 
xx xx 
Yes / Inconclusive 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: 
[a] Actual time is the difference (in hours) from study drug administration to sample collection. 
 
Programming Notes:  
1) add pre-dose concentrations of Rabeprazole also in this listing. 
2) Sort by analyte, subject number, day, and timepoint. 
3) Include all scheduled visits/timepoints. 
a. 
If a sample is not collected at a scheduled visit/timepoint, collection data is presented as "-". 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 138 of 169 
Sep 
Listing 16.2.6.2-1 Plasma PK Parameters of (PK Parameter Population) - Part 1 
 
Analyte 
Subject  
Number 
Study 
Day 
Parameter 
Result  
Unit 
Excluded? / 
If Yes, Reason 
 
 
 
 
 
 
 
Camlipixant 
xxxxx 
Day 1 
AUC0-t 
N/A 
xx 
Yes / Not estimable 
 
 
 
AUC0-inf 
xxxxxxx 
xx 
No 
 
 
 
Cl/F 
xxxxxxx 
xx 
No 
 
 
 
Cmax  
xxxxxxx 
xx 
No 
 
 
 
Kel 
xxxxxxx 
xx 
No 
 
 
 
Residual area 
N/A 
xx 
Yes / Not estimable  
 
 
 
Tmax 
xxxxxxx 
xx 
N 
 
 
 
T1/2 el 
xxxxxxx 
xx 
No 
 
 
 
Vz/F 
xxxxxxx 
xx 
No 
 
 
 
… 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: PK=Pharmacokinetic(s) 
 
Programming Notes: 
1) Sort by analyte, subject number and day. 
2) Add abbreviations used in the table to the footnotes. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 139 of 169 
Sep 
Listing 16.2.6.2-2 Plasma PK Parameters of (PK Parameter Population) - Part 2 
 
Analyte 
Subject  
Number 
Study  
Day 
Parameter 
Result  
Unit 
Excluded? / 
If Yes, Reason 
 
 
 
 
 
 
 
Camlipixant 
xxxxx 
Day 1 
AUC0-t 
N/A 
xx 
Yes / Not estimable 
 
 
 
AUC0-inf 
xxxxxxx 
xx 
No 
 
 
 
Cl/F 
xxxxxxx 
xx 
No 
 
 
 
Cmax  
xxxxxxx 
xx 
No 
 
 
 
Kel 
xxxxxxx 
xx 
No 
 
 
 
Residual area 
N/A 
xx 
Yes / Not estimable  
 
 
 
Tmax 
xxxxxxx 
xx 
N 
 
 
 
T1/2 el 
xxxxxxx 
xx 
No 
 
 
 
Vz/F 
xxxxxxx 
xx 
No 
 
 
 
… 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: PK=Pharmacokinetic(s) 
 
Programming Notes: 
1) Sort by analyte, subject number and day. 
2) Add abbreviations used in the table to the footnotes. 
 
 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 140 of 169 
Sep 
Listing 16.2.7.1-1 Non-TEAEs (Safety Population) - Part 1 
Subject 
Number 
MedDRA® System Organ Class / 
MedDRA Preferred Term / 
AE Term 
Onset  
Date / Time / 
Resolution  
Date / Time 
Severity / 
Relationship 
 
Action Taken 
Outcome 
Subject 
Discontinued/ 
serious/AEMI 
Other Recorded 
Information 
Study Drug 
 
Treatment 
 
 
 
 
 
 
 
 
 
xxxxx 
SOC 1 / 
PT 1 / 
TERM 1 
ddmmmyyyy / hh:mm / 
 
xxx/xxx 
Dose Not Changed  
  
xxx 
Recovered/ 
Resolved 
No / No / No 
xxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; AEMI=Adverse events of medical interest; ID=Identifier; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=Treatment-
emergent adverse event; 
Note: AE terms were coded using MedDRA version X.X. 
 
Programming Notes: 
1) Sort by subject number, onset date / time, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”.  
3) Use
 coding “/~n” between terms to generate break lines between SOC, PT, and description. 
4) Use 
 coding “/~n” to generate a break line between dates and between Severity and Relationship. 
5) If needed, hardcode outcome and actions to introduce break line (~n) between answer elements. 
6) If AE is ongoing, replace resolution date / time with “ONGOING” (in uppercase). 
7) If onset or resolution time is unknown, replace time with “UNKNOWN” (in uppercase) 
8) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
9) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
10) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 141 of 169 
Sep 
Listing 16.2.7.1-2 Non-TEAEs (Safety Population) - Part 2 
Subject 
Number 
MedDRA® System Organ Class / 
MedDRA Preferred Term / 
AE Term 
Onset  
Date / Time / 
Resolution  
Date / Time 
Severity / 
Relationship 
 
Action Taken 
Outcome 
Subject 
Discontinued/ 
serious/AEMI 
Other Recorded 
Information 
Study Drug 
 
Treatment 
 
 
 
 
 
 
 
 
 
xxxxx 
SOC 1 / 
PT 1 / 
TERM 1 
ddmmmyyyy / hh:mm / 
 
xxx/xxx 
Dose Not Changed  
  
xxx 
Recovered/ 
Resolved 
No / No / No 
xxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; AEMI=Adverse events of medical interest; ID=Identifier; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=Treatment-
emergent adverse event; 
Note: AE terms were coded using MedDRA version X.X. 
 
Programming Notes: 
1) Sort by subject number, onset date / time, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”.  
3) Use
 coding “/~n” between terms to generate break lines between SOC, PT, and description. 
4) Use 
 coding “/~n” to generate a break line between dates and between Severity and Relationship. 
5) If needed, hardcode outcome and actions to introduce break line (~n) between answer elements. 
6) If AE is ongoing, replace resolution date / time with “ONGOING” (in uppercase). 
7) If onset or resolution time is unknown, replace time with “UNKNOWN” (in uppercase) 
8) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
9) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
10) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 142 of 169 
Sep 
Listing 16.2.7.2-1 TEAEs (Safety Population) - Part 1 
Subject 
Number 
 
 
 
Treatment 
Phase 
MedDRA® System Organ Class / 
MedDRA Preferred Term / 
AE Term 
Onset  
Date / Time / 
Resolution  
Date / Time 
Severity / 
Relationship: 
to Camlipixant / 
to Rifampin 
Actions Taken: 
with Camlipixant / 
with Rifampin / 
Other 
Outcome 
Did the AE 
cause the 
subject to be 
discontinued 
from the 
study? / Is the 
AE serious? / Is 
this an AEMI? 
Other Recorded 
Information 
 
 
 
 
 
 
 
 
 
xxxxx 
 
Rifampin 
SOC 1 / 
PT 1 / 
TERM 1 
ddmmmyyyy / hh:mm / 
ddmmmyyyy / hh:mm 
Mild / 
Not Related / 
Possible 
Dose Not Changed / 
Dose Not Changed / 
None   
Recovered/ 
Resolved 
No / No / No 
xxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; AEMI=Adverse events of medical interest; ID=Identifier; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=Treatment-
emergent adverse event; 
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
 from Day 4 to Day 10, rifampin
 mg 
 from Day 11 to 12 with co-administration 
of camlipixant 50 mg SD on Day 11. 
AE terms were coded using MedDRA version X.X. 
 
Programming Notes: 
1) Sort by subject number, onset date / time, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”.  
3) Use 
 coding “/~n” between terms to generate break lines between SOC, PT, and description. 
4) Use 
coding “/~n” to generate a break line between dates and between Severity and Relationship. 
5) If needed, hardcode outcome and actions to introduce break line (~n) between answer elements. 
6) If AE is ongoing, replace resolution date / time with “ONGOING” (in uppercase). 
7) If onset or resolution time is unknown, replace time with “UNKNOWN” (in uppercase) 
8) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
9) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
10) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 143 of 169 
Sep 
Listing 16.2.7.2-2 TEAEs (Safety Population) - Part 2 
Subject 
Number 
 
 
 
Treatment 
Phase 
MedDRA® System Organ Class / 
MedDRA Preferred Term / 
AE Term 
Onset  
Date / Time / 
Resolution  
Date / Time 
Severity / 
Relationship: 
to Camlipixant / 
to Rabeprazole 
Actions Taken: 
with Camlipixant / 
with Rabeprazole / 
Other 
Outcome 
Did the AE 
cause the 
subject to be 
discontinued 
from the 
study? / Is the 
AE serious? / Is 
this an AEMI? 
Other Recorded 
Information 
 
 
 
 
 
 
 
 
 
xxxxx 
 
 
Rabeprazole 
 
 
SOC 1 / 
PT 1 / 
TERM 1 
ddmmmyyyy / 
hh:mm / 
ddmmmyyyy / 
hh:mm 
Mild / 
Not Related / 
Possible 
Dose Not Changed / 
Dose Not Changed / 
None   
Recovered/ 
Resolved 
No / No / No 
xxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; AEMI=Adverse events of medical interest; ID=Identifier; MedDRA=Medical Dictionary for Regulatory Activities; TEAE= 
Treatment-emergent adverse event; 
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
 mg 
 from Day 4 to Day 9, rabeprazole
 mg 
 from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
AE terms were coded using MedDRA version X.X. 
 
Programming Notes: 
1) Sort by subject number, onset date / time, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”.  
3) Use 
 coding “/~n” between terms to generate break lines between SOC, PT, and description. 
4) Use 
 coding “/~n” to generate a break line between dates and between Severity and Relationship. 
5) If needed, hardcode outcome and actions to introduce break line (~n) between answer elements. 
6) If AE is ongoing, replace resolution date / time with “ONGOING” (in uppercase). 
7) If onset or resolution time is unknown, replace time with “UNKNOWN” (in uppercase) 
8) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
9) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
10) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 144 of 169 
Sep 
Listing 16.2.7.3-1 Serious AEs (Safety Population) - Part 1 
Subject 
Number 
 
Treatment 
Phase 
MedDRA® System Organ Class / 
MedDRA Preferred Term / 
AE Term 
Onset Date / Time / 
Resolution Date / Time 
Severity / 
Relationship: 
to Camlipixant / 
to Rifampin  
Actions Taken: 
with Camlipixant / 
with Rifampin / 
Other 
Outcome 
Serious Reason 
 
 
 
 
 
 
 
 
xxxxx 
 
Camlipixant  
SOC 1 / 
PT 1 / 
TERM 1 
ddmmmyyyy / hh:mm / 
ddmmmyyyy / hh:mm 
Mild / 
Definite / 
Not Related / 
Dose Not Changed / 
Drug Interrupted / 
Hospitalization 
Recovered/ 
Resolved 
Life threatening 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=Treatment-emergent adverse event 
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
 from Day 4 to Day 10, rifampin 
mg 
from Day 11 to 12 with co-administration 
of camlipixant 50 mg SD on Day 11. 
AE terms were coded using MedDRA version X.X. 
 
Programming Notes: 
1) Sort by subject number, treatment, onset date / time, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”.  
3) Use
 coding “/~n” between terms to generate break lines between SOC, PT, and description. 
4) Use 
 coding “/~n” to generate a break line between dates and between Severity and Relationship. 
5) If needed, hardcode outcome and actions to introduce break line (~n) between answer elements. 
6) If AE is ongoing, replace resolution date / time with “ONGOING” (in uppercase). 
7) If onset or resolution time is unknown, replace time with “UNKNOWN” (in uppercase). 
8) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
9) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
10) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 145 of 169 
Sep 
Listing 16.2.7.3-2 Serious AEs (Safety Population) - Part 2 
Subject 
Number 
 
Treatment 
Phase 
MedDRA® System Organ Class / 
MedDRA Preferred Term / 
AE Term 
Onset Date / Time / 
Resolution Date / Time 
Severity / 
Relationship: 
to Camlipixant / 
to Rabeprazole 
Actions Taken: 
with Camlipixant / 
with Rabeprazole / 
Other 
Outcome 
Serious Reason 
 
 
 
 
 
 
 
 
xxxxx 
 
 
Camlipixant  
SOC 1 / 
PT 1 / 
TERM 1 
ddmmmyyyy / hh:mm / 
ddmmmyyyy / hh:mm 
Mild / 
Definite / 
Not Related / 
Dose Not Changed / 
Drug Interrupted / 
Hospitalization 
Recovered/ 
Resolved 
Life threatening 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; MedDRA=Medical Dictionary for Regulatory Activities; TEAE=Treatment-emergent adverse event 
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
 from Day 4 to Day 9, rabeprazole 
mg 
from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
AE terms were coded using MedDRA version X.X. 
 
Programming Notes: 
1) Sort by subject number, treatment, onset date / time, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”.  
3) Use 
 coding “/~n” between terms to generate break lines between SOC, PT, and description. 
4) Use 
 coding “/~n” to generate a break line between dates and between Severity and Relationship. 
5) If needed, hardcode outcome and actions to introduce break line (~n) between answer elements. 
6) If AE is ongoing, replace resolution date / time with “ONGOING” (in uppercase). 
7) If onset or resolution time is unknown, replace time with “UNKNOWN” (in uppercase). 
8) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
9) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
10) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 146 of 169 
Sep 
Listing 16.2.7.4-1 AEMIs (Safety Population) - Part 1 
Subject 
Number 
 
Treatment 
Phase 
MedDRA® System Organ Class / 
MedDRA Preferred Term / 
AE Term 
Onset Date / Time / 
Resolution Date / Time 
Severity / 
Relationship: 
to Camlipixant / 
to Rifampin 
Actions Taken: 
with Camlipixant / 
with Rifampin / 
Other 
Outcome 
Type of AEMI 
 
 
 
 
 
 
 
 
xxxxx 
 
 
Rifampin  
SOC 1 / 
PT 1 / 
TERM 1 
ddmmmyyyy / hh:mm / 
ddmmmyyyy / hh:mm 
Mild / 
Not Related / 
Unlikely  
 
Dose Not Changed / 
Dose Not Changed / 
None 
Recovered/ 
Resolved 
Oral Hypoesthesia 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; AEMI=Adverse events of medical interest; MedDRA=Medical Dictionary for Regulatory Activities;  
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
from Day 4 to Day 10, rifampin 
mg 
from Day 11 to 12 with co-administration 
of camlipixant 50 mg SD on Day 11. 
AE terms were coded using MedDRA version X.X. 
 
Programming Notes: 
1) Sort by subject number, treatment, onset date / time, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”. 
3) Use 
coding “/~n” between terms to generate break lines between SOC, PT, and description. 
4) Use 
 coding “/~n” to generate a break line between dates and between Severity and Relationship. 
5) If needed, hardcode outcome and actions to introduce break line (~n) between answer elements. 
6) If AE is ongoing, replace resolution date / time with “ONGOING” (in uppercase). 
7) If onset or resolution time is unknown, replace time with “UNKNOWN” (in uppercase). 
8) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
9) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
10) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 147 of 169 
Sep 
Listing 16.2.7.4-2 AEMIs (Safety Population) - Part 2 
Subject 
Number 
 
Treatment 
Phase 
MedDRA® System Organ Class / 
MedDRA Preferred Term / 
AE Term 
Onset Date / Time / 
Resolution Date / Time 
Severity / 
Relationship: 
to Camlipixant / 
to Rabeprazole 
Actions Taken: 
with Camlipixant / 
with Rabeprazole / 
Other 
Outcome 
Type of AEMI 
 
 
 
 
 
 
 
 
xxxxx 
 
 
Rabeprazole SOC 1 / 
PT 1 / 
TERM 1 
ddmmmyyyy / hh:mm / 
ddmmmyyyy / hh:mm 
Mild / 
Not Related / 
Unlikely / 
 
Dose Not Changed / 
Dose Not Changed / 
None 
Recovered/ 
Resolved 
Oral Hypoesthesia 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; AEMI=Adverse events of medical interest; MedDRA=Medical Dictionary for Regulatory Activities;  
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
 from Day 4 to Day 9, rabeprazole 
mg 
from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
AE terms were coded using MedDRA version X.X. 
 
Programming Notes: 
1) Sort by subject number, treatment, onset date / time, SOC, and PT. 
2) Present SOC and term in uppercase; present PT in “propcase”. 
3) Use 
 coding “/~n” between terms to generate break lines between SOC, PT, and description. 
4) Use 
 coding “/~n” to generate a break line between dates and between Severity and Relationship. 
5) If needed, hardcode outcome and actions to introduce break line (~n) between answer elements. 
6) If AE is ongoing, replace resolution date / time with “ONGOING” (in uppercase). 
7) If onset or resolution time is unknown, replace time with “UNKNOWN” (in uppercase). 
8) For incomplete date display, refer to CDISC SDTM Implementation Guide according to ISO 8601 format. 
9) Add abbreviations used in the table to the footnotes.  
a. 
MedDRA SOCs: Card=Cardiac disorders; Eye=Eye disorders; Gastr=Gastrointestinal disorders; Genrl=General disorders and administration site conditions; 
Infec=Infections and infestations; Inj&P=Injury, poisoning and procedural complications; Inv=Investigations; Musc=Musculoskeletal and connective tissue 
disorders; Nerv=Nervous system disorders; Psych=Psychiatric disorders; Resp=Respiratory, thoracic and mediastinal disorders; Skin=Skin and subcutaneous 
tissue disorders; Vasc=Vascular disorders 
10) In the footnote, replace “X.X” with the actual MedDRA version used in the study. 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 148 of 169 
Sep 
Programming Notes: 
1) Sort by subject number. 
2) Add abbreviations used in the table to the footnotes: 
a. 
PCR=Polymerase chain reaction 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 149 of 169 
Sep 
 
Programming Notes: 
1) Sort by subject number. 
2) Add abbreviations used in the table to the footnotes: 
a. 
PCR=Polymerase chain reaction 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 150 of 169 
Sep 
Listing 16.2.7.6-1 Oral Hypoesthesia, Oral Paresthesia AE Questionnaire (Safety Population) - Part 1 
Subject 
Number 
Was the assessment performed? / 
If No, Reason 
AE  
ID 
What type of oral hypoesthesia/paresthesia has 
the participant experienced? 
Are there other possible contributory factors to oral 
hypoesthesia/paresthesia? / If yes, specify 
 
 
 
 
 
xxxxx 
Yes 
xx 
Oral Hypoesthesia 
Yes / xxxxxxxxxxxxx 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; ID=Identifier 
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rifampin 
mg 
 from Day 4 to Day 10, rifampin 
 mg 
 from Day 11 to 12 with co-administration 
of camlipixant 50 mg SD on Day 11. 
 
Programming Notes: 
1) Sort by subject number. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 151 of 169 
Sep 
Listing 16.2.7.6-2 Oral Hypoesthesia, Oral Paresthesia AE Questionnaire (Safety Population) - Part 2 
Subject 
Number 
Was the assessment performed? / 
If No, Reason 
AE  
ID 
What type of oral hypoesthesia/paresthesia has 
the participant experienced? 
Are there other possible contributory factors to oral 
hypoesthesia/paresthesia? / If yes, specify 
 
 
 
 
 
xxxxx 
Yes 
xx 
Oral Hypoesthesia 
Yes / xxxxxxxxxxxxx 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; ID=Identifier 
Note: Treatment sequence: camlipixant 50 mg SD on Day 1, rabeprazole 
mg 
 from Day 4 to Day 9, rabeprazole
 mg 
from Day 10 to 11 with co-
administration of camlipixant 50 mg SD on Day 10. 
 
Programming Notes: 
1) Sort by subject number. 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 152 of 169 
Sep 
Listing 16.2.8.1-1 Biochemistry (Safety Population) - Part 1 
Subject 
Number 
Study 
Day 
Was the sample collected? / 
If No, Reason 
Date / Time of 
Collection 
Parameter 
(unit) 
Actual 
Value 
Actual Change 
from Baseline[a] 
Normal Range 
(LLN-ULN) 
Flag[b] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx.x 
N/A 
xxx.x-xxx.x 
H, CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; H=Above normal range (high); ID=Identifier; L=Below normal range (low); LLN=Lower limit of normal; 
MH=Medical history; N=Within normal range; NCS=Not clinically significant; ULN=Upper limit of normal 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] H, L, or N; if abnormal (H or L), CS or NCS  
  
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 153 of 169 
Sep 
Listing 16.2.8.1-2 Biochemistry (Safety Population) - Part 2 
Subject 
Number 
Study 
Day 
Was the sample collected? / 
If No, Reason 
Date / Time of 
Collection 
Parameter 
(unit) 
Actual 
Value 
Actual Change 
from Baseline[a] 
Normal Range 
(LLN-ULN) 
Flag[b] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx.x 
N/A 
xxx.x-xxx.x 
H, CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; H=Above normal range (high); ID=Identifier; L=Below normal range (low); LLN=Lower limit of normal; 
MH=Medical history; N=Within normal range; NCS=Not clinically significant; ULN=Upper limit of normal 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] H, L, or N; if abnormal (H or L), CS or NCS  
 
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 154 of 169 
Sep 
Listing 16.2.8.2-1 Hematology (Safety Population) - Part 1 
Subject 
Number 
Study 
Day 
Was the sample collected? / 
If No, Reason 
Date / Time of 
Collection 
Parameter 
(unit) 
Actual 
Value 
Actual Change 
from Baseline[a] 
Normal Range 
(LLN-ULN) 
Flag[b] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx.x 
N/A 
xxx.x-xxx.x 
H, CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; H=Above normal range (high); ID=Identifier; L=Below normal range (low); LLN=Lower limit of normal; 
MH=Medical history; N=Within normal range; NCS=Not clinically significant; ULN=Upper limit of normal 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] H, L, or N; if abnormal (H or L), CS or NCS  
  
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
 
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Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 155 of 169 
Sep 
Listing 16.2.8.2-2 Hematology (Safety Population) - Part 2 
Subject 
Number 
Study 
Day 
Was the sample collected? / 
If No, Reason 
Date / Time of 
Collection 
Parameter 
(unit) 
Actual 
Value 
Actual Change 
from Baseline[a] 
Normal Range 
(LLN-ULN) 
Flag[b] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx.x 
N/A 
xxx.x-xxx.x 
H, CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; H=Above normal range (high); ID=Identifier; L=Below normal range (low); LLN=Lower limit of normal; 
MH=Medical history; N=Within normal range; NCS=Not clinically significant; ULN=Upper limit of normal 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] H, L, or N; if abnormal (H or L), CS or NCS  
  
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 156 of 169 
Sep 
Listing 16.2.8.3-1 Coagulation (Safety Population) - Part 1 
Subject 
Number 
Study 
Day 
Was the sample collected? / 
If No, Reason 
Date / Time of 
Collection 
Parameter 
(unit) 
Actual 
Value 
Actual Change 
from Baseline[a] 
Normal Range 
(LLN-ULN) 
Flag[b] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx.x 
N/A 
xxx.x-xxx.x 
H, CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; H=Above normal range (high); ID=Identifier; L=Below normal range (low); LLN=Lower limit of normal; 
MH=Medical history; N=Within normal range; NCS=Not clinically significant; ULN=Upper limit of normal 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] H, L, or N; if abnormal (H or L), CS or NCS  
 
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 157 of 169 
Sep 
Listing 16.2.8.3-2 Coagulation (Safety Population) - Part 2 
Subject 
Number 
Study 
Day 
Was the sample collected? / 
If No, Reason 
Date / Time of 
Collection 
Parameter 
(unit) 
Actual 
Value 
Actual Change 
from Baseline[a] 
Normal Range 
(LLN-ULN) 
Flag[b] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx.x 
N/A 
xxx.x-xxx.x 
H, CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; H=Above normal range (high); ID=Identifier; L=Below normal range (low); LLN=Lower limit of normal; 
MH=Medical history; N=Within normal range; NCS=Not clinically significant; ULN=Upper limit of normal 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] H, L, or N; if abnormal (H or L), CS or NCS  
  
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 158 of 169 
Sep 
Listing 16.2.8.4-1 Urinalysis: Quantitative (Safety Population) - Part 1 
Subject 
Number 
Study 
Day 
Was the sample collected? / 
If No, Reason 
Date / Time of 
Collection 
Parameter 
(unit) 
Actual 
Value 
Actual Change 
from Baseline[a] 
Normal Range 
(LLN-ULN) 
Flag[b] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx.x 
N/A 
xxx.x-xxx.x 
H, CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; H=Above normal range (high); ID=Identifier; L=Below normal range (low); LLN=Lower limit of normal; 
MH=Medical history; N=Within normal range; NCS=Not clinically significant; ULN=Upper limit of normal 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] H, L, or N; if abnormal (H or L), CS or NCS  
  
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 159 of 169 
Sep 
Listing 16.2.8.4-2 Urinalysis: Quantitative (Safety Population) - Part 2 
Subject 
Number 
Study 
Day 
Was the sample collected? / 
If No, Reason 
Date / Time of 
Collection 
Parameter 
(unit) 
Actual 
Value 
Actual Change 
from Baseline[a] 
Normal Range 
(LLN-ULN) 
Flag[b] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx.x 
N/A 
xxx.x-xxx.x 
H, CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; H=Above normal range (high); ID=Identifier; L=Below normal range (low); LLN=Lower limit of normal; 
MH=Medical history; N=Within normal range; NCS=Not clinically significant; ULN=Upper limit of normal 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] H, L, or N; if abnormal (H or L), CS or NCS  
 
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 160 of 169 
Sep 
Listing 16.2.8.5-1 Urinalysis: Categorical (Safety Population) - Part 1 
Subject 
Number 
Study Day 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Parameter 
(unit) 
Result 
Normal Range 
(LLN-ULN) 
Flag[a] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
Trace 
xxx.x-xxx.x 
CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; ID=Identifier; LLN=Lower limit of normal; MH=Medical history; NCS=Not clinically significant; 
ULN=Upper limit of normal 
[a] CS or NCS  
 
Programming Notes: 
1) Include all visits. 
2) Include all categorical parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 161 of 169 
Sep 
Listing 16.2.8.5-2 Urinalysis: Categorical (Safety Population) - Part 2 
Subject 
Number 
Study Day 
Was the sample collected? / 
If No, Reason 
Date / Time of Collection 
Parameter 
(unit) 
Result 
Normal Range 
(LLN-ULN) 
Flag[a] 
Corresponding AE ID(s) / 
Corresponding MH ID(s) 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
Trace 
xxx.x-xxx.x 
CS 
N/A / 1 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: AE=Adverse event; CS=Clinically significant; ID=Identifier; LLN=Lower limit of normal; MH=Medical history; NCS=Not clinically significant; 
ULN=Upper limit of normal 
[a] CS or NCS  
 
Programming Notes: 
1) Include all visits. 
2) Include all categorical parameters in alphabetical order. 
3) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 162 of 169 
Sep 
Listing 16.2.8.6-1 Vital Signs (Safety Population) - Part 1 
Subject 
Number 
Study 
Day 
Was the assessment 
performed? / 
If No, Reason 
Date / Time of Assessment 
Parameter 
(unit) 
Actual Value 
Normal Range 
Actual Change 
from Baseline[a] 
Interpretation[b] 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx 
xxx-xxx 
N/A 
Normal 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; NCS=Not clinically significant 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] Normal or abnormal, if abnormal, CS or NCS  
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters. 
3) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 163 of 169 
Sep 
Listing 16.2.8.6-2 Vital Signs (Safety Population) - Part 2 
Subject 
Number 
Study 
Day 
Was the assessment 
performed? / 
If No, Reason 
Date / Time of Assessment Parameter 
(unit) 
Actual Value 
Normal Range Actual Change 
from Baseline[a] 
Interpretation[b] 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
xxxx (xx) 
xxx 
xxx-xxx 
N/A 
Normal 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; NCS=Not clinically significant 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] Normal or abnormal, if abnormal, CS or NCS  
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters. 
3) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 164 of 169 
Sep 
Listing 16.2.8.7-1 ECGs (Safety Population) - Part 1 
Subject 
Number 
Study 
Day 
Was the assessment 
performed? / 
If No, Reason 
Date / Time of Assessment ECG Position  Parameter (unit) 
Actual Value 
Normal Range 
Actual Change 
from Baseline[a] 
Overall 
Interpretation[b] 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
Supine 
xxxx (xx) 
xxx 
xxx-xxx 
N/A 
Normal 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; ECG=Electrocardiogram; NCS=Not clinically significant 
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[a] Normal or abnormal, if abnormal, CS or NCS.  
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters. 
3) Add abbreviations used in the table to the footnotes. 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 165 of 169 
Sep 
Listing 16.2.8.7-2 ECGs (Safety Population) - Part 2 
Subject 
Number 
Study 
Day 
Was the assessment 
performed? / 
If No, Reason 
Date / Time of Assessment ECG Position  Parameter (unit) 
Actual Value 
Normal Range 
Actual Change 
from Baseline[a] 
Overall 
Interpretation[b] 
 
 
 
 
 
 
 
 
 
 
xxxxx 
Day x[a] 
Yes 
ddmmmyyyy / hh:mm 
Supine 
xxxx (xx) 
xxx.x 
xxx-xxx 
N/A 
Normal 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; ECG=Electrocardiogram; NCS=Not clinically significant  
[a] Baseline value; baseline is defined as the last result (scheduled or unscheduled) obtained prior to study drug administration. 
[b] Normal or abnormal, if abnormal, CS or NCS. 
 
Programming Notes: 
1) Include all visits. 
2) Include all parameters. 
3) Add abbreviations used in the table to the footnotes. 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 166 of 169 
Sep 
Listing 16.2.8.8-1 Physical Examination (Safety Population) - Part 1 
Subject 
Number 
Study 
Day 
Assessment Type[a] Was the assessment performed? / 
If No, Reason 
Date / Time of 
Assessment 
Body System 
Result[b] 
Abnormal Findings 
 
 
 
 
 
 
 
 
xxxxx 
Day x 
Complete 
Yes 
ddmmmyyyy / hh:mm 
HEENT 
Normal 
N/A 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; NCS=Not clinically significant 
[a] Brief or complete 
[b] Normal or abnormal; if abnormal: CS or NCS 
 
Programming Notes: 
1) Include all visits. 
2) Include all body systems. 
3) Add abbreviations used in the table to the footnotes. 
a. 
HEENT= head, eyes, ears, nose, and throat 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 167 of 169 
Sep 
Listing 16.2.8.8-2 Physical Examination (Safety Population) - Part 2 
Subject 
Number 
Study Day 
Assessment Type[a] 
Was the assessment 
performed? / 
If No, Reason 
Date / Time of 
Assessment 
Body System 
Result[b] 
Abnormal Findings 
 
 
 
 
 
 
 
 
xxxxx 
Day x 
Complete 
Yes 
ddmmmyyyy / hh:mm 
HEENT 
Normal 
N/A 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: CS=Clinically significant; NCS=Not clinically significant 
[a] Brief or complete 
[b] Normal or abnormal; if abnormal: CS or NCS 
 
Programming Notes: 
1) Include all visits. 
2) Include all body systems. 
3) Add abbreviations used in the table to the footnotes. 
a. 
HEENT= head, eyes, ears, nose, and throat 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 168 of 169 
Sep 
Listing 16.2.8.8-3 Pharmacogenomic Measurements (Pharmacogenomic Population) - Part 1 
Subject Number 
Study Day 
Date / Time of Sample Collection 
Result  
Unit 
 
 
 
 
 
xxxxx 
Day x 
ddmmmyyyy / hh:mm 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
CCI


Statistical Analysis Plan (Table/Figure/Listing Shells)  
Bellus Health Protocol 220254 (BUS-P1-11) 
 
 
 
 
26-Oct-2023 (Final 1.0) 
Page 169 of 169 
Sep 
Listing 16.2.8.8-4 Pharmacogenomic Measurements (Pharmacogenomic Population) - Part 2 
Subject Number 
Study Day 
Date / Time of Sample Collection 
Result  
Unit 
 
 
 
 
 
xxxxx 
Day x 
ddmmmyyyy / hh:mm 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
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