A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Participants to Evaluate the Relative Bioavailability of Maribavir Pediatric Formulation Compared to the Commercial Formulation, as Well as, Food Effect, and Rabeprazole Gastric Acid-Reducing Effect on the Pharmacokinetics of Single-Dose Maribavir Pediatric Formulation
Phase: PHASE1
Conditions: Healthy Volunteers
Sponsor: Takeda

For non-commercial use only

 
 
 
TAKEDA PHARMACEUTICALS 
PROTOCOL 
A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Participants to 
Evaluate the Relative Bioavailability of Maribavir Pediatric Formulation Compared to the 
Commercial Formulation, as well as, Food Effect, and Rabeprazole Gastric Acid-Reducing 
Effect on the Pharmacokinetics of Single-Dose Maribavir Pediatric Formulation 
Study Identifier: 
TAK-620-1024 
Compound: 
Maribavir (TAK-620) 
Date: 
11 April 2023 
Version/Amendment 
Number: 
Version 1.0 
CONFIDENTIAL PROPERTY OF TAKEDA 
This document is a confidential communication of Takeda. Acceptance of this document constitutes the agreement 
by the recipient that no information contained herein will be published or disclosed without written authorization 
from Takeda except to the extent necessary to obtain informed consent from those persons to whom the drug may be 
administered. Furthermore, the information is only meant for review and compliance by the recipient, his or her 
staff, and applicable institutional review committee and regulatory agencies to enable conduct of the study. 
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TABLE OF CONTENTS 
LIST OF IN-TEXT TABLES ..........................................................................................................7 
LIST OF APPENDICES ..................................................................................................................7 
1.0 
STUDY SUMMARY...........................................................................................................8 
2.0 
STUDY SCHEMATIC ......................................................................................................15 
3.0 
SCHEDULE OF STUDY PROCEDURES .......................................................................18 
4.0 
INTRODUCTION .............................................................................................................23 
4.1 
Maribavir Background .................................................................................................23 
4.2 
Rabeprazole Background .............................................................................................27 
4.3 
Rationale for the Proposed Study ................................................................................28 
4.4 
Benefit/Risk Profile .....................................................................................................28 
5.0 
STUDY OBJECTIVES AND ENDPOINTS .....................................................................29 
5.1 
Hypothesis....................................................................................................................29 
5.2 
Study Objectives ..........................................................................................................29 
5.2.1 Primary Objectives.................................................................................................29 
5.2.2 Secondary Objective ..............................................................................................29 
5.2.3 Exploratory Objectives ..........................................................................................29 
5.3 
Endpoints .....................................................................................................................30 
5.3.1 Primary Endpoints .................................................................................................30 
5.3.2 Secondary Endpoints .............................................................................................30 
5.3.3 Exploratory Endpoints ...........................................................................................30 
6.0 
STUDY DESIGN AND DESCRIPTION ..........................................................................32 
6.1 
Study Design ................................................................................................................32 
6.2 
Dose Escalation ............................................................................................................33 
6.3 
Stopping Rules .............................................................................................................33 
6.4 
Rationale for Study Design, Dose, and Endpoints .......................................................34 
6.4.1 Rationale of Study Design .....................................................................................34 
6.4.2 Rationale for Dose .................................................................................................34 
6.4.3 Rationale for Endpoints .........................................................................................35 
6.4.3.1 Pharmacokinetic Endpoints ...........................................................................35 
6.4.3.2 Safety Endpoints ............................................................................................35 
6.4.4 Critical Procedures Based on Study Objectives: Timing of Procedures................35 
6.5 
Study Design/Dosing/Procedures Modifications Permitted Within Protocol 
Parameters ....................................................................................................................35 
6.6 
Study Beginning and End/Completion ........................................................................35 
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6.6.1 Definition of Beginning of the Study.....................................................................35 
6.6.2 Definition of End of the Study ...............................................................................35 
6.6.3 Definition of Study Discontinuation ......................................................................35 
6.6.4 Criteria for Premature Termination or Suspension of the Study ...........................36 
6.6.5 Criteria for Premature Termination or Suspension of a Site..................................36 
7.0 
SELECTION AND DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS ......37 
7.1 
Inclusion Criteria .........................................................................................................37 
7.2 
Exclusion Criteria ........................................................................................................37 
7.3 
Excluded Medications, Supplements, Dietary Products ..............................................39 
7.4 
Diet, Fluid, Activity .....................................................................................................40 
7.4.1 Diet and Fluid ........................................................................................................40 
7.4.2 Activity ..................................................................................................................41 
7.5 
Criteria for Discontinuation or Withdrawal of a Participant .......................................42 
7.6 
Procedures for Discontinuation or Withdrawal of a Participant ..................................43 
7.7 
Participant Replacement ..............................................................................................43 
8.0 
CLINICAL STUDY MATERIAL MANAGEMENT .......................................................44 
8.1 
Clinical Investigational Drug .......................................................................................44 
8.1.1 Clinical Study Drug Labeling ................................................................................44 
8.1.2 Clinical Study Drug Inventory and Storage ...........................................................44 
8.1.3 Clinical Study Drug Blinding ................................................................................45 
8.1.4 Randomization Code Creation and Storage (Part 1) ..............................................45 
8.1.5 Assignment to Treatments (Part 2) ........................................................................45 
8.1.6 Clinical Study Blind Maintenance/Unblinding Procedure ....................................45 
8.1.7 Accountability and Destruction of Sponsor-Supplied Drugs.................................45 
9.0 
STUDY PROCEDURES ...................................................................................................46 
9.1 
Administrative Procedures ...........................................................................................46 
9.1.1 Informed Consent Procedure .................................................................................46 
9.1.1.1 Assignment of Screening and Randomization Numbers ...............................46 
9.1.1.2 Study Drug Assignment ................................................................................46 
9.1.2 Inclusion and Exclusion .........................................................................................46 
9.1.3 Medical History/Demography ...............................................................................46 
9.1.4 Concomitant Medications ......................................................................................46 
9.2 
Clinical Procedures and Assessments ..........................................................................46 
9.2.1 Full Physical Exam ................................................................................................47 
9.2.2 Height and Weight .................................................................................................47 
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9.2.3 BMI ........................................................................................................................47 
9.2.4 Vital Signs ..............................................................................................................47 
9.2.5 12-Lead ECG .........................................................................................................47 
9.2.6 Study Drug Administration ....................................................................................48 
9.2.7 AE Monitoring .......................................................................................................48 
9.2.8 Laboratory Procedures and Assessments ...............................................................48 
9.2.8.1 Clinical Laboratory Tests ..............................................................................49 
9.3 
PK Samples ..................................................................................................................50 
9.3.1 PK Measurements ..................................................................................................50 
9.3.1.1 Plasma for PK Measurements .......................................................................51 
9.3.2 Biomarker Measurements ......................................................................................52 
9.3.3 PGx Measurements ................................................................................................52 
9.4 
Palatability ...................................................................................................................52 
9.5 
Confinement .................................................................................................................52 
10.0 
ADVERSE EVENTS .........................................................................................................53 
10.1 
Definitions and Elements of AEs .................................................................................53 
10.1.1 SAEs ......................................................................................................................55 
10.1.2 Adverse Events of Special Interest ........................................................................56 
10.2 
AE Procedures .............................................................................................................56 
10.2.1 Assigning Severity/Intensity of AEs ......................................................................56 
10.2.2 Assigning Causality of AEs ...................................................................................56 
10.2.3 Start Date ...............................................................................................................57 
10.2.4 End Date.................................................................................................................57 
10.2.5 Pattern of Adverse Event (Frequency) ...................................................................57 
10.2.6 Action Taken With Study Treatment .....................................................................57 
10.2.7 Outcome .................................................................................................................58 
10.2.8 Collection and Reporting of AEs, SAEs, AESIs, and Abnormal LFTs .................58 
10.2.8.1 Collection Period ...........................................................................................58 
10.2.8.2 Reporting AEs ...............................................................................................58 
10.2.8.3 Reporting SAEs .............................................................................................59 
10.2.8.4 Reporting AESIs ............................................................................................60 
10.2.8.5 Reporting of Abnormal LFTs ........................................................................60 
10.2.9 Safety Reporting to Investigators, IRBs, and Regulatory Authorities ...................60 
11.0 
STATISTICAL METHODS ..............................................................................................62 
11.1 
Statistical and Analytical Plans ....................................................................................62 
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11.1.1 Analysis Sets ..........................................................................................................62 
11.1.1.1 PK Set ............................................................................................................62 
11.1.1.2 Safety Set .......................................................................................................62 
11.1.1.3 Palatability Set (Part 1 only) ..........................................................................62 
11.1.2 Analysis of Demography and Other Baseline Characteristics ...............................62 
11.1.3 PK Analysis ...........................................................................................................62 
11.1.4 Pharmacodynamic Analysis ...................................................................................63 
11.1.5 Safety Analysis ......................................................................................................63 
11.1.5.1 AEs ................................................................................................................63 
11.1.5.2 Clinical Laboratory Evaluation .....................................................................64 
11.1.5.3 Vital Signs .....................................................................................................64 
11.1.5.4 Other Safety Parameters ................................................................................64 
11.1.6 Exploratory Analysis .............................................................................................64 
11.2 
Interim Analysis and Criteria for Early Termination ...................................................64 
11.3 
Determination of Sample Size .....................................................................................65 
12.0 
QUALITY CONTROL AND QUALITY ASSURANCE .................................................66 
12.1 
Study-Site Monitoring Visits .......................................................................................66 
12.2 
Protocol Deviations ......................................................................................................66 
12.3 
Quality Assurance Audits and Regulatory Agency Inspections ..................................66 
13.0 
ETHICAL ASPECTS OF THE STUDY ...........................................................................67 
13.1 
IRB Approval ...............................................................................................................67 
13.2 
Participant Information, Informed Consent, and Participant Authorization ................68 
13.3 
Participant Confidentiality ...........................................................................................69 
13.4 
Publication, Disclosure, and Clinical Study Registration Policy .................................69 
13.4.1 Publication and Disclosure ....................................................................................69 
13.4.2 Clinical Study Registration ....................................................................................70 
13.4.3 Clinical Study Results Disclosure ..........................................................................70 
13.5 
Insurance and Compensation for Injury .......................................................................70 
14.0 
ADMINISTRATIVE AND REFERENCE INFORMATION ...........................................71 
14.1 
Administrative Information .........................................................................................71 
14.1.1 Study Contact Information .....................................................................................71 
14.1.2 INVESTIGATOR AGREEMENT.........................................................................72 
14.1.3 Study-Related Responsibilities ..............................................................................73 
14.1.4 List of Abbreviations .............................................................................................73 
15.0 
DATA HANDLING AND RECORDKEEPING ..............................................................76 
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15.1 
CRFs (Electronic and Paper) .......................................................................................76 
15.2 
Record Retention .........................................................................................................76 
16.0 
REFERENCES ..................................................................................................................78 
17.0 
APPENDICES ...................................................................................................................80 
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LIST OF IN-TEXT TABLES 
Table 2.a 
Study Schematic for Part 1 ....................................................................................15 
Table 2.b 
Study Schematic for Part 2 ....................................................................................16 
Table 2.c 
Study Treatments with Investigational Drug/Study Drug .....................................17 
Table 3.a 
Relative Bioavailability and Food Effect (Part 1)..................................................18 
Table 3.b 
Gastric Acid-reducing Effect of Rabeprazole (Part 2) ...........................................20 
Table 4.a 
Statistical Comparison of Maribavir PK Parameters by Treatment - Part 1 of 
the Study TAK-620-1019 ......................................................................................25 
Table 7.a 
Excluded Medications, Supplements, and Dietary Products .................................40 
Table 7.b 
Examples of High-Fat/High-Calorie Meals and Breakdown of Calories and 
Contents .................................................................................................................41 
Table 8.a 
Randomization Sequences in Part 1 .......................................................................45 
Table 9.a 
Primary Specimen Collections ...............................................................................50 
Table 9.b 
PK Sampling Collection Window ..........................................................................50 
Table 11.a 
Estimated 90% CI for the Test / Reference GMR of AUC∞ or Cmax Based on 
Different Number of Participants for Part 1 and Part 2 .........................................65 
 
LIST OF APPENDICES 
Appendix A 
Responsibilities of the Investigator ........................................................................80 
Appendix B 
Elements of the Participant Informed Consent ......................................................82 
Appendix C 
Investigator Consent to the Use of Personal Information ......................................85 
Appendix D 
Pregnancy and Contraception ................................................................................86 
 
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1.0 
STUDY SUMMARY 
Name of Sponsor: 
Takeda Development Center Americas, Inc. (TDCA) 
95 Hayden Avenue 
Lexington, MA 02421 
Telephone: +1 (617) 679-7000 
Compound: 
Maribavir (TAK-620) 
Study Identifier: TAK-620-1024 
Phase: 1 
Protocol Title: A Phase 1, Open-Label, Randomized, Two-Part Study in Healthy Adult Participants to Evaluate 
the Relative Bioavailability of Maribavir Pediatric Formulation Compared to the Commercial Formulation, as 
well as, Food Effect, and Rabeprazole Gastric Acid-Reducing Effect on the Pharmacokinetics of Single-Dose 
Maribavir Pediatric Formulation 
Study Design: 
This single-center, open-label study in healthy adult participants will be conducted at Celerion in the United 
States (US). The study will include two parts (Part 1 and Part 2). Each study part will be composed of a 
screening period, treatment periods (three treatment periods in Part 1 and two treatment periods in Part 2), and a 
follow-up period. Participants will only participate in one study part. 
In Part 1, the relative bioavailability of maribavir pediatric formulation compared to maribavir commercial tablet 
formulation will be evaluated, as well as the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) 
exposure of a single dose of maribavir pediatric formulation. 
In Part 2, the gastric acid-reducing effect of multiple doses of a proton pump inhibitor (PPI), rabeprazole, on the 
PK of a single dose of maribavir pediatric formulation will be evaluated. 
Study schematics and dose regimens are shown in Table 2.a (Part 1), Table 2.b (Part 2), and Table 2.c. The 
schedules of assessments are shown in the Schedule of Study Procedures (Section 3.0). 
Participants will be screened within four weeks (28 days) prior to the first administration of maribavir in 
Treatment Period 1 (Screening Period: Day -28 to first dosing, Day 1). Eligible participants will be admitted to 
the Clinical Research Unit (CRU) on Day -1 of Treatment Period 1, at the time indicated by the CRU, and will 
remain confined until after the last study procedures on Day 2 of Treatment Period 3 (Part 1), or Day 6 of 
Treatment Period 2 (Part 2). 
Part 1: 
Part 1 is a crossover design with three treatments (Treatments A, B, and C), six sequences, and three periods. 
The relative bioavailability of 200 mg maribavir pediatric formulation administered orally as water suspension 
under fasting conditions (Treatment B) will be compared to 200 mg maribavir commercial tablet administered 
orally under fasting conditions (Treatment A). In addition, the effect of food on the PK of 200 mg maribavir 
pediatric formulation administered orally as water suspension under fasting conditions (Treatment B) and fed 
conditions (Treatment C) will be assessed. 
A total of 18 participants will be enrolled, with three participants per sequence in each of the six sequences. In 
each sequence, participants will receive three treatments (Treatments A, B, and C) per schedule. 
There will be a washout period of a minimum of 72 hours between each dosing. 
PK sample collections will be conducted predose and up to 24 hours postdose in each treatment period. 
Within five minutes after administration of maribavir pediatric formulation (Treatment B and Treatment C), 
participants will be asked to answer a questionnaire regarding its palatability. The palatability questionnaire will 
be provided to the participants for preview during check-in. 
Part 2: 
Part 2 is a single fixed-sequence design with two treatments (Treatments D and E). The two treatments will be 
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administered to evaluate the gastric acid-reducing effect of multiple doses of rabeprazole on the PK of a single 
dose of 200 mg maribavir pediatric formulation administered orally as water suspension. 
In Treatment Period 1, on Day 1, participants will receive a single oral dose of 200 mg maribavir pediatric 
formulation under fasting conditions (Treatment D). 
In Treatment Period 2, on Days 1 to 5, participants will receive a single oral dose of 20 mg rabeprazole under 
fasting conditions. On the morning of Day 5, two hours after rabeprazole dosing, participants will receive a 
single oral dose of 200 mg maribavir pediatric formulation under fasting conditions (Treatment E). 
A total of 14 participants will be enrolled. Participants will receive two treatments (Treatments D and E) in a 
single fixed order. 
There will be a washout period of a minimum of 72 hours between maribavir dosing in Treatment Period 1 and 
first dose of rabeprazole in Treatment Period 2. 
PK sample collections will be conducted pre-maribavir dose and up to 24 hours post maribavir dose in each 
treatment period. 
Parts 1 and 2: 
Safety and tolerability will be assessed throughout the study by treatment-emergent adverse events (TEAEs), 
vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations. 
The CRU will contact all participants (including participants who terminate the study early) 7 (± 4) days after the 
last dose of investigational drug (ID)/study drug by telephone or other methods per CRU standards to determine 
if any adverse event (AE) has occurred or any medications have been taken since the last study visit. If clinically 
significant findings are observed upon discharge from the CRU, participants may return to the CRU for 
re-evaluation per Investigator’s discretion. 
Study Primary Objectives: 
Part 1: 
• 
To compare the relative bioavailability of a single dose of 200 mg maribavir pediatric formulation 
administered orally as water suspension to 200 mg maribavir commercial tablet. 
• 
To assess the effect of a high-fat, high-calorie meal on the PK of a single 200-mg dose of maribavir 
pediatric formulation administered orally as water suspension. 
Part 2: 
• 
To assess the gastric acid-reducing effect of multiple doses of the PPI rabeprazole, on the PK exposure 
of a single dose of 200 mg maribavir pediatric formulation administered orally as water suspension. 
Study Secondary Objective: 
Part 1 and Part 2: 
• 
To evaluate the safety and tolerability of 200 mg maribavir pediatric formulation administered orally as 
water suspension under fasting conditions, fed conditions, or with the PPI rabeprazole. 
Exploratory Objectives: 
Part 1: 
• 
To assess the palatability of a single 200-mg dose of maribavir pediatric formulation administered 
orally as water suspension under fasting and fed conditions. 
Parts 1 and 2: 
• 
To evaluate additional maribavir PK parameters following a single 200-mg dose of maribavir 
commercial tablet administered orally under fasting conditions, and a single 200-mg dose of maribavir 
pediatric formulation administered orally as water suspension under fasting and fed conditions, or with 
the PPI rabeprazole. 
Study Participant Population: Healthy male and female participants aged 18 to 55 years, inclusive, with a 
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Body Mass Index (BMI) of 18.0-30.0 kg/m2, inclusive, at the screening visit. 
Planned Number of Participants: 
Thirty-two (32) participants will be enrolled; 
18 participants in Part 1 and 14 participants in 
Part 2. Participants will only participate in one study 
part. 
Planned Number of Sites: 
1 
Dose Levels: 
Part 1: 
200 mg maribavir commercial tablet or pediatric 
powder-for-oral suspension 
Part 2: 
200 mg maribavir pediatric powder-for-oral 
suspension 
20 mg rabeprazole tablet 
Route of Administration: 
Oral 
Duration of Treatment: 
Part 1: 
A single dose of maribavir on Day 1 in each 
treatment period 
Part 2: 
Once daily (QD) doses of rabeprazole for 5 days 
(Days 1 to 5) in Treatment Period 2 
A single dose of maribavir on Day 1 of Treatment 
Period 1 and on Day 5 of Treatment Period 2 
Planned Study Duration: 
Approximately 41 days (Part 1) and 43 days (Part 2) 
including screening period of up to 28 days and 
follow-up. 
Criteria for Inclusion: 
Participants must fulfill the following inclusion criteria before the first dose to be eligible for participation in the 
study: 
1. An understanding, ability, and willingness to fully comply with study procedures and restrictions. 
2. Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized 
representative) informed consent to participate in the study. 
3. Age 18 to 55 years, inclusive at the time of consent, at the screening visit. The date of signature of the 
informed consent is defined as the beginning of the screening period.  
4. Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive 
requirements of the protocol or female of non-childbearing potential. Additional details are outlined in 
Appendix D. 
5. BMI between 18.0 and 30.0 kg/m2, inclusive with a body weight >50 kg (110 lbs), at the screening visit. 
6. Healthy as determined by the Investigator or designee on the basis of screening evaluations and medical 
history. Healthy status is defined by absence of evidence of any active or chronic disease following a 
detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, 
hematology, blood chemistry (includes thyroid-stimulating hormone [TSH] and free thyroxin [FT4] at the 
screening visit), and urinalysis. 
7. Hemoglobin for males ≥135.0 g/L and females ≥120.0 g/L, at the screening visit and on Day -1 of Treatment 
Period 1. 
8. Ability to swallow a dose of maribavir or rabeprazole. 
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Criteria for Exclusion: 
Participants must not be enrolled in the study if they meet any of the following criteria before the first dose: 
1. History or presence of gastritis, gastrointestinal (GI) tract disorder, hepatic disorder or cholecystectomy, 
history of treated or untreated Helicobacter pylori, ulcer disease or other clinical condition which, in the 
opinion of the Investigator or designee, may affect the absorption, distribution, metabolism, or elimination 
of the study drugs. 
2. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, 
gall bladder removal, or current recurrent disease that could affect the action, absorption, or disposition of 
the study drugs, or clinical or laboratory assessments. 
3. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment 
or make the participant unlikely to fully complete the study, or any condition that presents undue risk from 
the study drugs or procedures. 
4. Known or suspected intolerance or hypersensitivity to maribavir or rabeprazole (Part 2 only), closely related 
compounds, or any of the stated ingredients and excipients. 
5. Significant illness, as judged by the Investigator or designee, within 2 weeks of the first dose of the ID. 
6. Has diarrhea within 4 hours of the first dose of the ID. 
7. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to receiving the first dose 
of the ID. 
8. Within 30 days prior to the first dose of the ID: 
• 
Have used any investigational product (if elimination half-life is <6 days, otherwise 5 half-lives). 
• 
Have been enrolled in a clinical study (including vaccine studies) that, in the Investigator or 
designee’s opinion, may impact this Takeda-sponsored study. 
• 
Have had any substantial changes in eating habits, as assessed by the Investigator or designee. 
9. Systolic blood pressure >140 mmHg or <90 mmHg, and/or diastolic blood pressure >90 mmHg or 
<50 mmHg, at the screening visit. 
10. Twelve-lead ECG demonstrating heart-rate corrected QT interval (QTc) >450 msec at the screening visit. If 
QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values 
should be used to determine the participant’s eligibility. 
11. Known history of alcohol or other substance abuse within the last year. 
12. Male participants who consume more than 21 units of alcohol per week or three units per day. Female 
participants who consume more than 14 units of alcohol per week or two units per day (one alcohol unit = 
one beer or one wine [5 oz/150 mL] or one liquor [1.5 oz/40 mL] or 0.75 oz alcohol). 
13. A positive screen for alcohol or drugs of abuse at the screening visit or on Day -1 of Treatment Period 1. 
Urine samples are to be tested for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, 
methadone, opiates, and phencyclidine. 
14. A positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus 
(HCV) antibody screen at the screening visit. 
15. Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form 
(eg, gum, patch). Ex-users must self-report that they have stopped using tobacco for at least 3 months prior 
to receiving the first dose. 
16. Routine consumption of more than two units of caffeine per day or participants who experience caffeine 
withdrawal headaches (One caffeine unit is contained in the following items: one 6-oz [180 mL] cup of 
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coffee, two 12-oz [360 mL] cans of cola, one 12-oz cup of tea, three 1-oz [85 g] chocolate bars). 
Decaffeinated coffee, tea, or cola are not considered to contain caffeine. 
17. Current use of any prescription medication with the exception of hormonal contraceptives and hormonal 
replacement therapy. Current use is defined as use within 30 days of the first dose. Current use of any 
over-the-counter medication (including over-the-counter multi-vitamin, herbal, or homeopathic 
preparations) within 14 days of the first dose. Hormonal contraceptives (refer to Appendix D) and hormonal 
replacement therapy may be permitted if the female participant has been on the same stable dose for at least 
3 months prior to first dose. Appropriate sources (eg, Flockhart TableTM) will be consulted to confirm lack 
of PK/pharmacodynamic interaction with maribavir and/or rabeprazole (Part 2 only).  
18. Current use of antacids, PPIs, or H2 antagonists within 14 days of the first dose, except for on-study 
rabeprazole. 
19. Inability or unwillingness to consume 100 percent of the high-fat, high calorie meal (including participants 
with lactose or gluten intolerance). 
20. Female participants with a positive pregnancy test at the screening visit or on Day -1 of Treatment Period 1 
or who are lactating. 
21. Participants on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, 
within the 30 days prior to the first dosing and throughout the study. 
22. Recent history (within 1 month) of oral/nasal cavity infections, history of gastroesophageal reflux, asthma 
treatment with albuterol, or zinc supplementation. 
23. Participants with dry mouth syndrome or burning mouth syndrome or participants suffering from dysgeusia. 
Main Criteria for Evaluation and Analyses: 
Primary Endpoints (Part 1 and Part 2): 
The following PK parameters in plasma will be analyzed for maribavir: 
• 
Maximum observed concentration (Cmax) 
• 
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration 
(AUClast) 
• 
Area under the concentration-time curve from time 0 to infinity, calculated using the observed value of 
the last quantifiable concentration (AUC∞) 
Secondary Endpoints (Part 1 and Part 2): 
Safety endpoints will include the following: 
• 
TEAEs and their number, severity, seriousness, and causality  
• 
Changes in vital signs, ECGs, and clinical laboratory results (hematology, chemistry, and urinalysis) 
from baseline to post-baseline time points, and evaluation of clinical signs. 
Exploratory Endpoints: 
Part 1: The palatability of the maribavir pediatric formulation will be evaluated. A semi-validated questionnaire 
will be used to identify, characterize, and quantify the sensory attributes of maribavir pediatric formulation 
including basic tastes, texture, and mouth feel, and to assess the overall acceptability. 
Part 1 and Part 2: Exploratory PK endpoints include (if applicable, but are not limited to) additional maribavir 
PK parameters as follows: 
• 
Time to first occurrence of Cmax (tmax) 
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• 
Area under the curve from the last quantifiable concentration to infinity, calculated using the observed 
value of the last quantifiable concentration, expressed as a percentage of AUC∞ (AUCextrap%) 
• 
Terminal disposition phase rate constant (λz) 
• 
Terminal disposition phase half-life (t½z) 
• 
Apparent volume of distribution during the terminal disposition phase after oral administration, 
calculated using the observed value of the last quantifiable concentration (Vz/F) 
• 
Apparent clearance after oral administration, calculated using the observed value of the last quantifiable 
concentration (CL/F) 
• 
Lag time to first quantifiable concentration in plasma (tlag) 
• 
Concentration at 12 hours postdose (C12h) 
• 
Area under the concentration-time curve from time 0 to 12 (AUC12h) 
• 
Projected trough concentration at 12 hours postdose after twice daily (BID) dosing (Cτ) 
Statistical Considerations: 
Pharmacokinetic analysis 
PK analysis will be based on the PK set. For both Part 1 and Part 2 of the study, individual maribavir plasma 
concentrations and PK parameters will be listed by participant and treatment and summarized by treatment 
(maribavir plasma concentrations and PK parameters) and nominal time (maribavir plasma concentrations). PK 
parameters (including but not limited to AUClast, AUC∞, Cmax, AUCextrap%, AUC12h, tmax, λz, CL/F, Vz/F, tlag, t½z, 
C12h, and Cτ) will be computed using standard non-compartmental analysis (NCA) analysis. Additionally, the 
primary PK endpoints will be descriptively analyzed, and graphically displayed. Selected plasma PK parameters 
may be statistically analyzed, as appropriate. PK analysis will be fully specified in the Clinical Pharmacology 
Analysis Plan (CPAP).  
Part 1 – Relative bioavailability and food effect estimation 
This analysis will be based on the PK set (Part 1 data).  
A mixed-effects model will be applied to log-transformed Cmax, AUClast, and AUC∞ with treatment, period and 
sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their 
associated 90% confidence intervals (CIs) will be constructed for the differences between Treatment B (test) 
versus Treatment A (reference), and Treatment C (test) versus Treatment B (reference). The point estimates and 
their associated 90% CIs will be then back transformed to provide point estimates and 90% CIs for the ratios of 
Treatment B (test) versus Treatment A (reference), and Treatment C (test) versus Treatment B (reference).  
Additionally, analysis of tmax and tlag will be performed by nonparametric Wilcoxon Signed-Rank test. 
Part 2 – PPI effect estimation 
This analysis will be based on the PK set (Part 2 data). 
A mixed-effects model will be applied to log-transformed Cmax, AUClast, and AUC∞ with treatment as a fixed 
effect, and participant as a random effect. Point estimates and their associated 90% CIs will be constructed for 
the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their 
associated 90% CIs will be then back transformed to provide point estimates and 90% CIs for the ratios of 
Treatment E (test) versus Treatment D (reference). 
Additionally, analysis of tmax and tlag will be performed by nonparametric Wilcoxon Signed-Rank test. 
Safety analysis: 
The safety data will be summarized descriptively for TEAEs, potentially clinically significant (PCS) clinical 
laboratory tests, vital signs, and 12-lead ECG. Concomitant medications will also be summarized by treatment. 
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Baseline will be the last assessment before the first dose. TEAEs are defined as those with a start date on or after 
the first dose, or with a start date before the date of first dose of maribavir but increasing in severity after the first 
dose. 
Palatability analysis: 
In Part 1, palatability data collected from the palatability questionnaire will be summarized descriptively using 
the Palatability Set (Part 1 only) for Treatments B and C (pediatric formulation) only. Percentages will be 
reported, based on the number of participants in the Palatability Set with any response to the corresponding 
question in each treatment. 
Additional exploratory analyses may be conducted and reported separately. 
Sample Size Justification: 
The sample size for Part 1 and Part 2 is based on precision. 
Table 11.a shows the estimated 90% CI for the geometric mean ratio (GMR) for maribavir AUC∞ and Cmax 
between Test versus Reference formulations based on expected intra-participant variability and different number 
of participants in Part 1 and Part 2. 
As shown in Table 11.a, for both Part 1 and Part 2, a sample size of 12 participants provides an adequate 90% CI 
for the GMR within (0.80, 1.25). 
In Part 1, six participants will be added for replacements to account for potential dropouts and to avoid potential 
sequence effect if replacement is required. Thus, a total of 18 participants will be enrolled and randomly assigned 
to one of six sequences with a 1:1:1:1:1:1 treatment allocation and requirement of three participants per 
sequence. 
In Part 2, two participants will be added for replacements to account for potential dropouts. Thus, a total of 
14 participants will be enrolled. 
 
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Table 2.c 
Study Treatments with Investigational Drug/Study Drug 
Treatment 
Investigational 
Drug/Study Drug 
Dose 
Dose Regimen 
Days on 
Investigational 
Drug/Study Drug 
A 
Maribavir commercial 
tablet  
200 mg (1 x 200-mg) 
Single dose, oral, fast  
Day 1 
B and D 
Maribavir pediatric 
powder-for-oral 
suspension  
200 mg (1 x 200-mg) 
Single dose, oral, fast 
Day 1 
C 
Maribavir pediatric 
powder-for-oral 
suspension  
200 mg (1 x 200-mg) 
Single dose, oral, fed: 
following a 
high-fat/high-calorie 
meal 
Day 1 
E 
Rabeprazole tablet 
20 mg (1 x 20-mg) 
Once daily, oral, fast 
Days 1 through 
Day 5 
Maribavir pediatric 
powder-for-oral 
suspension  
200 mg (1 x 200-mg) 
Single dose, oral, fast, 
2 hours after 
rabeprazole dose 
Day 5 
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a: 
For details on procedures, refer to Section 9.0. 
b: Within 28 days prior to the first dosing of the investigational drug. 
c: 
There will be a washout period of a minimum of 72 hours between each dosing.  
d: To be performed prior to early termination from the study. 
e: 
The CRU will contact all participants (including participants who terminate the study early) 7 (± 4) days after the last dose of investigational drug/study drug 
by telephone or other methods per CRU standards, to determine if any AE has occurred or concomitant medications have been taken since the last study 
visit. If clinically significant findings are observed upon discharge, participants may return to the CRU for re-evaluating per Investigator’s discretion. 
f: 
The 16-hour postdose on the day of dosing will be either on the same day or the day after dosing, depending on the time of dosing. 
g: To be performed in Treatment Period 3 only. 
h: To be performed within 2 hours prior to dosing. 
i: 
Samples for serum clinical chemistry will be obtained following a fast of at least 8 hours, however, in case of dropouts or rechecks, participants may not 
have fasted for 8 hours prior to the serum chemistry sample is taken.  
j: 
To be performed prior to the dosing in Treatment Period 2 and Treatment Period 3 only. 
k: To be performed at early termination only if termination was due to any AE. 
l: 
In Treatments A and B, participants will be dosed under fasting conditions. In Treatment C, participants will receive a meal 30 minutes prior to dosing; the 
meal will be entirely consumed within 25 minutes. 
m: To be performed within 1 hour prior to maribavir dosing. 
n: To be performed only in Treatments B and C, when participants will receive the pediatric formulation. The palatability questionnaire will be provided to the 
participants for preview during check-in. 
o: Participants will be admitted to the CRU on Day -1 of Treatment Period 1, at the time indicated by the CRU, and will stay until completion of study 
procedures on Day 2 of Treatment Period 3, or early termination from the study. 
 
♀ = Females, AE = Adverse events, BP = Blood pressure, C-I = Check-in, Chem = Chemistry, ConMeds = Concomitant medication, CRU = Clinical research 
unit, ECG = Electrocardiogram, ET =Early termination, FSH = Follicle-stimulating hormone, F/U = Follow-up, Hem = Hematology, HIV = Human 
immunodeficiency virus, PK = Pharmacokinetics, PMP = Postmenopausal, PR = Pulse rate, RR = Respiration rate, S = Screening, T = Temperature, 
UA = Urinalysis.  
 
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a: 
For details on procedures, refer to Section 9.0. 
b: Within 28 days prior to the first dosing of the investigational drug. 
c: 
There will be a washout period of a minimum of 72 hours between dosing in Treatment Period 1 and first dose in Treatment Period 2. 
d: Participants will be admitted to the CRU on Day -1 of Treatment Period 1, at the time indicated by the CRU, and will stay until completion of study 
procedures on Day 6 in Treatment Period 2, or early termination from the study. 
e: 
The 16-hour postdose on the day of maribavir dosing will be either on the same day or the day after maribavir dosing, depending on the time of maribavir 
dosing. 
f: 
To be performed within 2 hours prior to dosing. 
g: Samples for serum clinical chemistry will be obtained following a fast of at least 8 hours, however, in case of dropouts or rechecks, participants may not 
have fasted for 8 hours prior to the serum chemistry sample is taken. 
h: To be performed prior to early termination from the study. 
i: 
The CRU will contact all participant (including participants who terminate the study early) 7 (± 4) days after the last dose of investigational drug/study drug 
by telephone or other methods per CRU standards, to determine if any AE has occurred or concomitant medications have been taken since the last study 
visit. If clinically significant findings are observed upon discharge, participants may return to the CRU for re-evaluating per Investigator’s discretion. 
j: 
To be performed at early termination only if termination was due to any AE.  
k: To be performed within 1 hour prior to maribavir dosing. 
 
♀ = Females, AE = Adverse events, BP = Blood pressure, CI = Check-in, Chem = Chemistry, ConMeds = Concomitant medication, CRU = Clinical research 
unit, ECG = Electrocardiogram, ET = Early termination, FSH = Follicle-stimulating hormone, F/U = Follow-up, H. pylori = Helicobacter pylori, 
Hem = Hematology, HIV = Human immunodeficiency virus, PK = Pharmacokinetics, PMP = Postmenopausal, PR = Pulse rate, RR = Respiration rate,  
S = Screening, T = Temperature, UA = Urinalysis. 
 
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4.0 
INTRODUCTION 
4.1 
Maribavir Background 
Maribavir (LIVTENCITYTM) is a potent and selective, orally bioavailable antiviral drug with a 
novel mechanism of action against cytomegalovirus (CMV) [1]. 
LIVTENCITYTM (maribavir) is approved for the treatment of adults with post-transplant CMV 
infection/disease that is refractory (with or without genotypic resistance) to treatment with 
ganciclovir, valganciclovir, cidofovir, or foscarnet by the US Food and Drug Administration 
(FDA), the European Medicines Agency, Medicines and Healthcare Products Regulatory Agency 
(United Kingdom), Ministry of Food and Drug Safety (Republic of Korea), Health Canada, and 
Therapeutics Goods Administration (Australia). The US FDA approval also includes pediatric 
patients ≥12 years of age weighing at least 35 kg.  
The current approved maribavir dosing regimen for adults is 400 mg BID, administered as 
2x200 mg film-coated tablets. Maribavir tablets can be taken with or without food [1]. 
Clinical efficacy of maribavir has been demonstrated in one Phase 2 study and one Phase 3 study 
for the treatment of CMV infection or disease in adult transplant recipients, resistant or 
refractory to prior therapies. Maribavir had similar efficacy at clearing CMV viremia at doses 
≥400 mg BID (400, 800, or 1200 mg BID) and overall exhibited a favorable safety and 
tolerability profile [2]. The most frequent TEAEs associated with maribavir were dysgeusia and 
GI TEAEs, including diarrhea, nausea, and vomiting which were generally mild or moderate. 
Clinical pharmacology of maribavir in adults 
Maribavir is a potent member of the benzimidazole ribosides. It is the first and only antiviral 
agent that targets CMV UL97 protein kinase and its natural substrates. Maribavir inhibits viral 
DNA assembly and egress of viral capsids from the nucleus of infected cells [3]. Maribavir is a 
weak base (pKa of 5.2), and it is considered a Biopharmaceutics Classification System (BCS) 
class II drug, with high solubility at acidic pH but moderate to low solubility in neutral pH 
(0.8 mg/mL in water) [4]. 
Following oral tablet administration, maribavir is rapidly and well absorbed with mean peak 
plasma concentrations (Cmax) achieved between 1- and 3-hours postdose. Total exposure to 
maribavir, as measured by AUC, is approximately dose-proportional following a single dose 
from 50 to 1600 mg or multiple doses from 300 to 2400 mg per day, and maribavir demonstrates 
stationary PK. A Phase 1 study evaluating the effect of food on maribavir PK (Study 
TAK-620-1025) has shown that, compared to fasting conditions, low-fat/low-calorie or 
high-fat/high-calorie meals did not affect maribavir AUC (12.2% reduction) in a statistically 
significant level, and only modestly reduced Cmax (by ~23.5%), which was not considered 
clinically meaningful. Maribavir displays high plasma protein binding (98% in vitro and 98.5% 
to 99% ex vivo), independently of plasma concentrations. The mean elimination half-life (t1/2z) of 
maribavir is estimated to be between 4 and 5 hours in adult transplant patients. Maribavir is 
primarily eliminated by hepatic metabolism through cytochrome P450 (CYP) 3A4 and, to a 
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lesser extent, CYP1A2, leading to the formation of a primary metabolite, VP44469, which is 
much less active than maribavir in inhibition of the CMV UL97 protein. Renal clearance of 
maribavir is negligible (<2% of total clearance). 
Clinical drug-drug interactions (DDI) studies have shown that maribavir dose adjustment is only 
required when maribavir is co-administered with a strong or moderate CYP3A4 inducer [5]. 
However, caution should be exercised when maribavir is given with concomitant sensitive 
substrates of CYP1A2, P-glycoprotein, breast cancer resistance protein, and immunosuppressants 
tacrolimus, cyclosporine, everolimus or sirolimus. In addition, the effect of concomitant 
administration of PPI on maribavir PK was quantified in the population PK model developed for 
maribavir in adults. Model-derived estimates of steady-state AUCτ and Cmax for CMV patients 
following 400 mg BID maribavir were approximately 10% and 22.5% lower in the presence of 
concomitant PPI compared to without PPI comedication. However, these gastric acid-reducing 
effects of PPIs are not considered clinically significant. The most current information regarding 
the drug metabolism, PK, efficacy, and safety of maribavir is detailed in the Investigator’s 
Brochure (IB) for maribavir [4]. 
Clinical use of Maribavir in Pediatric Patients 
There are currently no approved agents for the treatment of CMV infections in pediatric 
transplant patients <12 years of age [5]. A Phase 3 study for maribavir in children and 
adolescents with CMV infection/disease who have undergone a hematopoietic stem cell 
transplant or solid organ transplant is being planned (Study TAK-620-2004). This study will 
include participants of three age-based cohorts: ≥12 to <18 years (Cohort 1), ≥6 to <12 years 
(Cohort 2), and 0 to <6 years (Cohort 3). The dose selection in pediatric transplant participants 
will be based on full extrapolation, ie, matching pediatric PK exposure to that observed at the 
therapeutic doses in adults. Based on population PK simulations with allometrically scaled PK 
parameters for pediatric participants receiving maribavir tablet formulation, it is expected that 
400 mg BID dosing in participants with body weight >25 kg and 200 mg BID dosing in 
participants with body weight from 10 to 25 kg would generate matching target PK exposures to 
400 mg BID in adults. For participants in Cohort 3, there is a significant need for a pediatric 
specific formulation. 
Maribavir has a strong and lingering bitter taste at clinically relevant doses. In order to have a 
palatable formulation for pediatric use, a taste-masking strategy that minimizes the availability of 
maribavir in the oral cavity was implemented. Two previously developed powder-for-oral 
suspension pediatric candidate formulations were evaluated in adult healthy participants in Study 
TAK-620-1019. This study was designed to be conducted in two parts. However only Part 1 of 
the study was conducted, as both pediatric candidate formulations had a bitter taste, with an 
acceptability rate lower than a preferred value of 80%. In addition, following administration of 
maribavir 200 mg 32.5% and 36.1% maribavir loaded powder-for-oral suspension formulations 
(Treatments B and C), the geometric mean Cmax and AUC∞ values were 32% and 38%, and 16% 
and 20% lower, respectively, compared to that of maribavir tablet formulation (Treatment A), as 
shown in Table 4.a. Both candidate formulations were generally safe and well tolerated. 
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Table 4.a 
Statistical Comparison of Maribavir PK Parameters by Treatment - Part 1 
of the Study TAK-620-1019 
PK Parameter 
(unit) 
Treatment 
N 
Geometric 
LS means 
Treatment 
comparison 
Ratio (%) of 
geometric LS 
means 
90% CI of the 
ratio (%) 
Cmax  
(µg/mL) 
A 
B 
C 
18 
19 
20 
10.6 
7.19 
6.61 
 
B versus A 
C versus A 
 
67.76 
62.29 
 
(59.50, 77.16) 
(54.73, 70.90) 
AUC∞  
(h*µg/mL) 
A 
B 
C 
18 
19 
20 
51.2 
42.8 
41.2 
 
B versus A 
C versus A 
 
83.52 
80.36 
 
(76.12, 91.64) 
(73.26, 88.16) 
AUClast 
 (h*µg/mL) 
A 
B 
C 
18 
19 
20 
48.7 
39.6 
38.0 
 
B versus A 
C versus A 
 
81.27 
78.00 
 
(73.88, 89.40) 
(70.92, 85.79) 
Treatment A=maribavir 200 mg tablet; Pivotal clinical (Phase 3) formulation 
Treatment B=maribavir 200 mg pediatric powder-for-oral suspension formulation, 32.5% drug loading 
Treatment C=maribavir 200 mg pediatric powder-for-oral suspension formulation, 36.1% drug loading 
ANOVA: analysis of variance; AUC∞: area under the curve extrapolated to infinity; AUClast: area under the curve 
from the time of dosing to the last measurable concentration; CI: confidence interval; Cmax: maximum 
concentration; LS: least squares; N: sample size, PK: pharmacokinetic 
Source: Study TAK-620-1019 clinical study report, Table 14.2.5.3.1 
 
The new proposed candidate pediatric formulation which will be used in this study, consists of 
the same maribavir granular powder as the formulation used in the Study TAK-620-1019 
(Treatment C). However additional sweetener and flavored excipients (eg, sucralose and berry 
citrus punch) were added to improve palatability. Prior to this study, a taste assessment study 
(Study TAK-620-1021) conducted in a sensory healthy panelist confirmed that the new proposed 
pediatric formulation provided considerably less bitter taste, although residual bitterness could 
persist in the aftertaste.  
This improved pediatric formulation is considered more suitable for the pediatric Phase 3 study, 
and no further masking strategy attempts will be considered given that many options have been 
already explored. In this study (TAK-620-1024), the palatability of the proposed pediatric 
formulation will be assessed as an exploratory objective.  
The maribavir pediatric formulation is designed to be reconstituted with water prior to 
administration to form an oral suspension suitable for younger children. Two dose strengths, 
compositionally proportional (ie, 50 mg and 200 mg) will be available to allow dose adjustment 
in pediatrics. Only the 200-mg dose strength will be tested in this study, one of the expected 
doses to be administered BID to children ≤6 years. Food intake and concomitantly administered 
PPIs (mainly omeprazole) were shown to have no clinically meaningful effects on the rate and 
extent of absorption of maribavir administered as the adult tablet formulation. However, 
considering the presence of the pH-sensitive coating polymer in addition to maribavir being a 
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BCS II drug, and to reduce risks of untoward effects on maribavir PK in the Phase 3 pediatric 
study, it will be important to evaluate the effects of food and gastric acid-reducing effect of PPI 
on the new pediatric formulation. 
The effect of a high-fat, high-calorie meal on maribavir PK will be analyzed. The gastric 
acid-reducing effect of PPI will be evaluated with a PPI agent presenting minimal risk of 
potential metabolism-based DDI with maribavir to avoid confounding factors. Omeprazole is a 
commonly used PPI in pediatrics; however, it is metabolized by several CYP enzymes including 
CYP2C19, CYP3A4, and CYP1A2, the latter two also shared by maribavir [7]. Unlike other PPI, 
rabeprazole is mainly metabolized by non-enzymatic pathways [7-9]. Rabeprazole has also 
demonstrated similar gastric acid-reducing capacity compared to other PPI such as omeprazole 
[10]. Thus, to solely evaluate the gastric acid-reducing effect of PPI on maribavir PK, 
rabeprazole will be used in this study.  
Safety Profile 
Maribavir has been administered across a broad range of oral doses from 50 to 2400 mg/day. 
Clinical safety data has been obtained from 19 Phase 1 studies in adult healthy participants, 
special populations (participants with renal and hepatic impairment, and stable renal transplant 
recipients), and HIV-infected participants. No death or other serious adverse events (SAEs) was 
reported in Phase 1 studies with maribavir. The most common TEAE in single- and 
multiple-dose Phase 1 studies was taste disturbance (dysgeusia). ECG, vital signs, and laboratory 
findings did not suggest any treatment-emergent abnormalities related to maribavir. A definitive 
QT study in healthy participants demonstrated no clinically significant repolarization effect of 
maribavir administered orally at single doses of 100 mg and 1200 mg. In addition, no other 
significant ECG effects of maribavir were found. Maribavir (400 mg BID) was shown to 
increase the whole blood trough concentration of tacrolimus by 57% in a clinical drug-drug 
interaction study. 
In two Phase 2 studies for CMV infection treatment (Studies SHP620-202 and SHP620-203) 
maribavir was well-tolerated with no safety concerns at all doses evaluated, ie, 400, 800, and 
1200 mg BID. In Study SHP620-202, the most frequent TEAEs (occurred in ≥20% of 
maribavir-treated participants) were dysgeusia, followed by nausea, vomiting, diarrhea, fatigue, 
and anemia. In Study SHP620-203, the most frequent TEAEs (occurred in ≥20% of 
maribavir-treated participants) were dysgeusia, followed by nausea, diarrhea and vomiting. 
Analyses of clinical laboratory, vital signs, and ECG data did not identify any clinically 
meaningful differences across the maribavir treatment groups. 
In a pivotal Phase 3 study for the treatment of CMV infection that is refractory or resistant to 
prior treatment (Study SHP620‑303), maribavir 400 mg BID was well tolerated and safe. 
Dysgeusia was the most frequently reported TEAE overall. Other frequently reported TEAEs 
>10% included nausea, diarrhea, vomiting, fatigue, and pyrexia. The TEAE of 
immunosuppressant drug level increased was reported in 21 participants in the maribavir group 
(9.0%). 
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In another pivotal Phase 3 study for the treatment of CMV infection (Study SHP620‑302), 
maribavir 400 mg BID was also well tolerated and safe. Nausea was the most frequently reported 
TEAE overall. Other frequently reported TEAEs >10% included diarrhea, vomiting, anaemia, 
neutropenia, thrombocytopenia, pyrexia, dysgeusia, and headache. TEAE of immunosuppressant 
drug level increased (2.9%) were also reported. 
To date, maribavir has shown an overall favorable safety profile in placebo-controlled studies, 
open-label studies, and in studies that compared maribavir with other CMV therapies 
(ganciclovir, valganciclovir) for prophylaxis and for CMV treatment in hematopoietic stem-cell 
transplant and solid organ transplant recipients. 
Refer to the latest version of the maribavir IB for the most detailed and most current information 
regarding the drug metabolism, PK, efficacy, and safety of maribavir [4]. 
4.2 
Rabeprazole Background 
Rabeprazole is used for the short-term (4 – 8 weeks) treatment of erosive or ulcerative 
esophagitis in patients with gastroesophageal reflux disease. Rabeprazole belongs to a class of 
antisecretory compounds (substituted benzimidazole PPIs) that suppress 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 [11].  
The antisecretory effect of rabeprazole begins within 1 hour after oral administration of a 20 mg 
dose. The median inhibitory effect of rabeprazole on 24-hour gastric acidity is 88% of maximal 
after the first dose. Rabeprazole (20 mg) inhibits basal and peptone meal-stimulated acid 
secretion versus placebo by 86% and 95%, respectively, and increases the percent of time out of 
a 24-hour period that the gastric pH is >3 from 10% to 65%, after 7 days of QD dosing. This 
relatively prolonged pharmacodynamic action compared to the short PK t½z (1-2 hours) reflects 
the sustained inactivation of the H⁺/K⁺-ATPase. There were no significant changes in the PK 
parameters (tmax, Cmax, AUC, and t½z) following rabeprazole administration (20 mg and 40 mg, 
n=6) for 7 days when assessed for Day 1 and Day 7. Potential PK interactions (ie, increased or 
decreased drug absorption) can occur as a result of the increased gastric pH levels from 
rabeprazole administration [11]. 
Following a 20 mg oral administration, peak plasma concentrations (Cmax) of rabeprazole occur 
over a range of 2.0 to 5.0 hours (tmax). The rabeprazole Cmax and AUC are linear over an oral 
dose range of 10 mg to 40 mg. There is no appreciable accumulation when doses of 10 mg to 
40 mg are administered every 24 hours; the PK of rabeprazole is not altered by multiple dosing 
[11]. 
The most common side effects with rabeprazole include pain, pharyngitis, flatulence, infection, 
and constipation. 
Refer to the full prescribing information for more detailed background on rabeprazole [11]. 
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4.3 
Rationale for the Proposed Study 
In this study, the relative bioavailability of a new maribavir pediatric candidate formulation will 
be compared to the approved maribavir tablet formulation, and the food effect as well as the 
gastric acid-reducing effect of concomitantly administered rabeprazole on the PK of maribavir in 
pediatric formulation in healthy adult participants will be evaluated. The results of this study will 
be critical to provide information relevant for further evaluation of maribavir in the youngest 
cohort of pediatric patients (≤6 years of age) with CMV infection/disease in the maribavir 
pediatric Phase 3 study (Study TAK-620-2004). 
4.4 
Benefit/Risk Profile 
To date, maribavir has been safe and well tolerated in placebo-controlled studies, open-label 
studies, and in studies that compared maribavir with other CMV therapies (ganciclovir, 
valganciclovir) for prophylaxis and for CMV treatment in stem cell transplant and SOT patients. 
Always refer to the latest version of the maribavir IB for the overall benefit/risk assessment and 
the most accurate and current information regarding drug metabolism, PK, efficacy, and safety of 
maribavir [9]. 
The dose of rabeprazole to be administered in this study is not anticipated to induce any potential 
risk to participants taking part in this study, as it will be administered according to the dosing 
recommendations found in the full prescribing information for rabeprazole [11]. 
There will be no direct health benefit for study participants from receipt of the study drugs. An 
indirect health benefit to the healthy participants enrolled in this study is the free medical tests 
performed at screening and during the study. 
The inclusion and exclusion criteria, screening, and safety monitoring practices employed by this 
protocol (ie, 12-lead ECG, vital signs, clinical laboratory tests, AE questioning, and physical 
examination) are adequate to monitor the participant’s safety. 
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5.0 
STUDY OBJECTIVES AND ENDPOINTS 
5.1 
Hypothesis 
Not applicable. 
5.2 
Study Objectives 
5.2.1 
Primary Objectives 
Part 1: 
• To compare the relative bioavailability of a single dose of 200 mg maribavir pediatric 
formulation administered orally as water suspension to 200 mg maribavir commercial 
tablet. 
• To assess the effect of a high-fat, high-calorie meal on the PK exposure of a single 
200-mg dose of maribavir pediatric formulation administered orally as water suspension. 
Part 2: 
• To assess the gastric acid-reducing effect of multiple doses of the PPI rabeprazole, on the 
PK exposure of a single dose of 200 mg maribavir pediatric formulation administered 
orally as water suspension. 
5.2.2 
Secondary Objective 
Parts 1 and 2: 
• To evaluate the safety and tolerability of 200 mg maribavir pediatric formulation 
administered orally as water suspension under fasting conditions, fed conditions, or with 
the PPI rabeprazole. 
5.2.3 
Exploratory Objectives 
Part 1: 
• To assess the palatability of a single 200-mg dose of maribavir pediatric formulation 
administered orally as water suspension under fasting and fed conditions. 
Parts 1 and 2: 
• To evaluate additional maribavir PK parameters following a single 200-mg dose of 
maribavir commercial tablet administered orally under fasting conditions, and a single 
200-mg dose of maribavir pediatric formulation administered orally as water suspension 
under fasting and fed conditions, or with the PPI rabeprazole. 
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5.3 
Endpoints 
5.3.1 
Primary Endpoints 
In Parts 1 and 2, the following PK parameters in plasma will be analyzed for maribavir: 
• Maximum observed concentration (Cmax) 
• Area under the concentration-time curve from time 0 to the time of the last quantifiable 
concentration (AUClast) 
• Area under the concentration-time curve from time 0 to infinity, calculated using the 
observed value of the last quantifiable concentration (AUC∞) 
5.3.2 
Secondary Endpoints 
In Parts 1 and 2, the safety endpoints will include the following: 
• TEAEs and their number, severity, seriousness, and causality  
• Changes in vital signs, ECGs, and clinical laboratory results (hematology, chemistry, and 
urinalysis) from baseline to post-baseline time points, and evaluation of clinical signs. 
5.3.3 
Exploratory Endpoints 
In Part 1, the palatability of the maribavir pediatric formulation will be evaluated. A 
semi-validated questionnaire will be used to identify, characterize, and quantify the sensory 
attributes of maribavir pediatric formulation including basic tastes, texture, and mouth feel, and 
to assess the overall acceptability. 
In Parts 1 and 2, exploratory PK endpoints include (if applicable, but are not limited to) 
additional maribavir PK parameters as follows: 
• Time to first occurrence of Cmax (tmax) 
• Area under the curve from the last quantifiable concentration to infinity, calculated using 
the observed value of the last quantifiable concentration, expressed as a percentage of 
AUC∞ (AUCextrap%) 
• Terminal disposition phase rate constant (λz) 
• Terminal disposition phase half-life (t½z) 
• Apparent volume of distribution during the terminal disposition phase after oral 
administration, calculated using the observed value of the last quantifiable concentration 
(Vz/F) 
• Apparent clearance after oral administration, calculated using the observed value of the 
last quantifiable concentration (CL/F) 
• Lag time to first quantifiable concentration in plasma (tlag) 
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• Concentration at 12 hours postdose (C12h) 
• Area under the concentration-time curve from time 0 to 12 (AUC12h) 
• Projected trough concentration at 12 hours postdose after BID dosing (Cτ) 
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6.0 
STUDY DESIGN AND DESCRIPTION 
6.1 
Study Design 
This single-center, open-label study in healthy adult participants will be conducted at Celerion in 
the US. The study will include two parts (Part 1 and Part 2). Each study part will be composed of 
a screening period, treatment periods (three treatment periods in Part 1 and two treatment periods 
in Part 2), and a follow-up period. Participants will only participate in one study part. 
In Part 1, the relative bioavailability of maribavir pediatric formulation compared to maribavir 
commercial tablet formulation will be evaluated, as well as the effect of a high-fat, high-calorie 
meal on the PK exposure of a single dose of maribavir pediatric formulation. 
In Part 2, the gastric acid-reducing effect of multiple doses of a PPI, rabeprazole, on the PK of a 
single dose of maribavir pediatric formulation will be evaluated. 
Study schematics and dose regimens are shown in Table 2.a (Part 1), Table 2.b (Part 2), and 
Table 2.c. The schedules of assessments are shown in the Schedule of Study Procedures 
(Section 3.0). 
Participants will be screened within four weeks (28 days) prior to the first administration of 
maribavir in Treatment Period 1 (Screening Period: Day -28 to first dosing, Day 1). Eligible 
participants will be admitted to the CRU on Day -1 of Treatment Period 1, at the time indicated 
by the CRU, and will remain confined until after the last study procedures on Day 2 of Treatment 
Period 3 (Part 1), or Day 6 of Treatment Period 2 (Part 2). 
Part 1: 
Part 1 is a crossover design with three treatments (Treatments A, B, and C), six sequences, and 
three periods. 
The relative bioavailability of 200 mg maribavir pediatric formulation administered orally as 
water suspension under fasting conditions (Treatment B) will be compared to 200 mg maribavir 
commercial tablet administered orally under fasting conditions (Treatment A). In addition, the 
effect of food on the PK of 200 mg maribavir pediatric formulation administered orally as water 
suspension under fasting conditions (Treatment B) and fed conditions (Treatment C) will be 
assessed. 
A total of 18 participants will be enrolled, with three participants per sequence in each of the 
six sequences. In each sequence, participants will receive three treatments (Treatments A, B, and 
C) per schedule. 
There will be a washout period of a minimum of 72 hours between each dosing. 
PK sample collections will be conducted predose and up to 24 hours postdose in each treatment 
period. 
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Within five minutes after administration of maribavir as pediatric formulation (Treatment B and 
Treatment C), participants will be asked to answer a questionnaire regarding its palatability. The 
palatability questionnaire will be provided to the participants for preview during check-in. 
Part 2: 
Part 2 is a single fixed-sequence design with two treatments (Treatments D and E). The 
two treatments will be administered to evaluate the gastric acid-reducing effect of multiple doses 
of rabeprazole on the PK of a single dose of 200 mg maribavir pediatric formulation 
administered orally as water suspension. 
In Treatment Period 1, on Day 1, participants will receive a single oral dose of 200 mg maribavir 
pediatric formulation under fasting conditions (Treatment D). 
In Treatment Period 2, on Days 1 to 5, participants will receive a single oral dose of 20 mg 
rabeprazole under fasting conditions. On the morning of Day 5, two hours after rabeprazole 
dosing, participants will receive a single oral dose of 200 mg maribavir pediatric formulation 
under fasting conditions (Treatment E). 
A total of 14 participants will be enrolled. Participants will receive two treatments (Treatments D 
and E) in a single fixed order. 
There will be a washout period of a minimum of 72 hours between maribavir dosing in 
Treatment Period 1 and first dose of rabeprazole in Treatment Period 2. 
PK sample collections will be conducted pre-maribavir dose and up to 24 hours post maribavir 
dose in each treatment period. 
Parts 1 and 2: 
Safety and tolerability will be assessed throughout the study by TEAEs, vital signs, ECGs, and 
clinical laboratory evaluations. 
The CRU will contact all participants (including participants who terminate the study early) 
7 (± 4) days after the last dose of ID/study drug by telephone or other methods per CRU 
standards to determine if any AE has occurred or any medications have been taken since the last 
study visit. If clinically significant findings are observed upon discharge from the CRU, 
participants may return to the CRU for re-evaluation per Investigator’s discretion. 
6.2 
Dose Escalation 
Not applicable. 
6.3 
Stopping Rules 
Not applicable. 
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6.4 
Rationale for Study Design, Dose, and Endpoints 
6.4.1 
Rationale of Study Design 
This study is being conducted to assess the relative bioavailability, food effect, and the gastric 
acid-reducing effect of a PPI on the PK of maribavir pediatric formulation. 
The study is designed according to the FDA guidance on bioavailability and food effect studies 
for new drug applications (NDA) but as well to the FDA guidance entitled Evaluation of 
gastric-pH dependent drug interactions with acid reducing agents [12]. 
The study is conducted in two parts, which may be conducted concurrently. 
In Part 1, participants will be randomized to treatment sequences to minimize assignment bias. 
There will be a washout period of a minimum of 72 hours between dosing in each treatment 
period. The washout period is considered sufficient to prevent carryover effects of the preceding 
treatment. 
In Part 2, participants will receive both treatments in a single fixed order. Rabeprazole has a 
prolonged effect on acid secretion due to the irreversible nature of its binding to H⁺/K⁺-ATPase 
pump. Therefore rabeprazole will be administered in Treatment Period 2 to prevent the risk of 
confounding carryover of residual gastric acid suppression effect on the PK evaluation of 
maribavir alone. 
A crossover design is used to reduce the residual variability as every participant acts as their own 
control. There will be a washout period of a minimum of 72 hours between dosing in Treatment 
Period 1 and the first dosing in Treatment Period 2. The washout period is considered sufficient 
to prevent carryover effects of the preceding treatment. 
6.4.2 
Rationale for Dose 
A single dose of 200 mg maribavir pediatric candidate formulation will be used as this is one of 
the expected doses to be administered BID to children ≤6 years. 
A dose of 20 mg rabeprazole will be used as this is within the recommended dose range per 
labeling of ACIPHEX® [11]. Rabeprazole 20 mg inhibits basal and peptone meal-stimulated acid 
secretion by 86% and 95%, respectively, versus placebo, and increases the percent of time out of 
a 24-hour period that the gastric pH is >3 from 10% to 65%, following QD dosing for 7 days. In 
additional, following 5 days of QD 20 mg rabeprazole, the intragastric pH was maintained above 
4.0 for a mean of 12.1 hour [11]. This study will therefore evaluate the effect of rabeprazole on 
the PK of maribavir following 5 days of rabeprazole 20 mg QD. Maribavir will be administered 
2 hours after rabeprazole dosing, which is within the range of rabeprazole tmax, to maximize the 
inhibitory effect on gastric acid excretion on the day of coadministration. 
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6.4.3 
Rationale for Endpoints 
6.4.3.1 
Pharmacokinetic Endpoints 
The PK endpoints are standard for this type of study. 
6.4.3.2 
Safety Endpoints 
The key safety endpoints are typical for Phase 1 studies and will be assessed through monitoring 
of TEAEs, vital signs, ECGs, laboratory assessments, and physical examinations. 
6.4.4 
Critical Procedures Based on Study Objectives: Timing of Procedures 
For this study, the critical component is the blood collection for plasma concentrations of 
maribavir, and is to be collected as close to the scheduled times defined in this protocol as 
possible. 
6.5 
Study Design/Dosing/Procedures Modifications Permitted Within Protocol 
Parameters 
The dose and administration of maribavir and rabeprazole to any participant may not be 
modified. If necessary, a participant may be discontinued for the reasons described in Section 7.5 
and Section 7.6. 
6.6 
Study Beginning and End/Completion 
6.6.1 
Definition of Beginning of the Study 
The beginning of the study will be defined as the beginning of the screening (ie, signing of the 
informed consent form [ICF]) by the first participant. 
6.6.2 
Definition of End of the Study 
The end of study is defined as the date of the last scheduled procedure. If there is an unresolved 
AE or concomitant medication, or an assessment date that is after the end of study, the date of 
study completion will be inclusive of that resolution/assessment date. 
A study participant is considered to have completed the study if the participant completed 
dosing, did not discontinue or terminate the study early, and has completed most of the 
scheduled procedures in all periods including the last scheduled procedure ie, the follow-up 
contact, as outlined in the Schedule of Study Procedures (Section 3.0). 
6.6.3 
Definition of Study Discontinuation 
Celerion reserves the right to terminate the study in the interest of participant welfare. 
The Sponsor reserves the right to suspend or terminate the study at any time. 
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6.6.4 
Criteria for Premature Termination or Suspension of the Study 
The study will be completed as planned unless one or more of the following criteria are satisfied 
that require temporary suspension or early termination from the study: 
• New safety information of maribavir and/or rabeprazole that indicates a change in the known 
product risk-benefit profile, such that the risk is no longer acceptable for study participants. 
• Significant violation of Good Clinical Practice (GCP) that compromises the ability to achieve 
the primary study objectives or compromises participant safety. 
6.6.5 
Criteria for Premature Termination or Suspension of a Site 
Not applicable. 
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7.0 
SELECTION AND DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS 
7.1 
Inclusion Criteria 
Participants must fulfill the following inclusion criteria before the first dose to be eligible for 
participation in the study: 
1. An understanding, ability, and willingness to fully comply with study procedures and 
restrictions. 
2. Ability to voluntarily provide written, signed, and dated (personally or via a legally 
authorized representative) informed consent to participate in the study. 
3. Age 18 to 55 years, inclusive at the time of consent, at the screening visit. The date of 
signature of the informed consent is defined as the beginning of the screening period.  
4. Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable 
contraceptive requirements of the protocol or female of non-childbearing potential. 
Additional details are outlined in Appendix D. 
5. BMI between 18.0 and 30.0 kg/m2, inclusive with a body weight >50 kg (110 lbs), at the 
screening visit. 
6. Healthy as determined by the Investigator or designee on the basis of screening evaluations 
and medical history. Healthy status is defined by absence of evidence of any active or 
chronic disease following a detailed medical and surgical history, a complete physical 
examination including vital signs, 12-lead ECG, hematology, blood chemistry (includes TSH 
and FT4 at the screening visit), and urinalysis. 
7. Hemoglobin for males ≥135.0 g/L and females ≥120.0 g/L, at the screening visit and on 
Day -1 of Treatment Period 1. 
8. Ability to swallow a dose of maribavir or rabeprazole. 
7.2 
Exclusion Criteria 
Participants must not be enrolled in the study if they meet any of the following criteria before the 
first dose: 
1. History or presence of gastritis, GI tract disorder, hepatic disorder or cholecystectomy, 
history of treated or untreated Helicobacter pylori, ulcer disease or other clinical condition 
which, in the opinion of the Investigator or designee, may affect the absorption, distribution, 
metabolism, or elimination of the study drugs. 
2. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or 
psychiatric disease, gall bladder removal, or current recurrent disease that could affect the 
action, absorption, or disposition of the study drugs, or clinical or laboratory assessments. 
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3. Current or relevant history of physical or psychiatric illness, any medical disorder that may 
require treatment or make the participant unlikely to fully complete the study, or any 
condition that presents undue risk from the study drugs or procedures. 
4. Known or suspected intolerance or hypersensitivity to maribavir or rabeprazole (Part 2 only), 
closely related compounds, or any of the stated ingredients and excipients. 
5. Significant illness, as judged by the Investigator or designee, within 2 weeks of the first dose 
of the ID. 
6. Has diarrhea within 4 hours of the first dose of the ID. 
7. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to 
receiving the first dose of the ID. 
8. Within 30 days prior to the first dose of the ID: 
• Have used any investigational product (if elimination half-life is <6 days, otherwise 
5 half-lives). 
• Have been enrolled in a clinical study (including vaccine studies) that, in the 
Investigator or designee’s opinion, may impact this Takeda-sponsored study. 
• Have had any substantial changes in eating habits, as assessed by the Investigator or 
designee. 
9. Systolic blood pressure >140 mmHg or <90 mmHg, and/or diastolic blood pressure 
>90 mmHg or <50 mmHg, at the screening visit. 
10. Twelve lead-ECG demonstrating QTc >450 msec at the screening visit. If QTc exceeds 
450 msec, the ECG should be repeated two more times and the average of the three QTc 
values should be used to determine the participant’s eligibility. 
11. Known history of alcohol or other substance abuse within the last year. 
12. Male participants who consume more than 21 units of alcohol per week or three units per 
day. Female participants who consume more than 14 units of alcohol per week or two units 
per day (one alcohol unit = one beer or one wine [5 oz/150 mL] or one liquor [1.5 oz/40 mL] 
or 0.75 oz alcohol). 
13. A positive screen for alcohol or drugs of abuse at the screening visit or on Day -1 of 
Treatment Period 1. Urine samples are to be tested for amphetamines, barbiturates, 
benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine. 
14. A positive HIV, HBsAg, or HCV antibody screen at the screening visit. 
15. Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products 
in any form (eg, gum, patch). Ex-users must self-report that they have stopped using tobacco 
for at least 3 months prior to receiving the first dose. 
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16. Routine consumption of more than two units of caffeine per day or participants who 
experience caffeine withdrawal headaches (One caffeine unit is contained in the following 
items: one 6-oz [180 mL] cup of coffee, two 12-oz [360 mL] cans of cola, one 12-oz cup of 
tea, three 1-oz [85 g] chocolate bars). Decaffeinated coffee, tea, or cola are not considered to 
contain caffeine. 
17. Current use of any prescription medication with the exception of hormonal contraceptives 
and hormonal replacement therapy. Current use is defined as use within 30 days of the first 
dose. Current use of any over-the-counter medication (including over-the-counter 
multi-vitamin, herbal, or homeopathic preparations) within 14 days of the first dose. 
Hormonal contraceptives (refer to Appendix D) and hormonal replacement therapy may be 
permitted if the female participant has been on the same stable dose for at least 3 months 
prior to first dose. Appropriate sources (eg, Flockhart TableTM) will be consulted to confirm 
lack of PK/pharmacodynamic interaction with maribavir and/or rabeprazole (Part 2 only).  
18. Current use of antacids, PPIs, or H2 antagonists within 14 days of the first dose, except for 
on-study rabeprazole. 
19. Inability or unwillingness to consume 100 percent of the high-fat, high-calorie meal 
(including participants with lactose or gluten intolerance). 
20. Female participants with a positive pregnancy test at the screening visit or on Day -1 of 
Treatment Period 1 or who are lactating. 
21. Participants on a diet incompatible with the on-study diet, in the opinion of the Investigator 
or designee, within the 30 days prior to the first dosing and throughout the study. 
22. Recent history (within 1 month) of oral/nasal cavity infections, history of gastroesophageal 
reflux, asthma treatment with albuterol, or zinc supplementation. 
23. Participants with dry mouth syndrome or burning mouth syndrome or participants suffering 
from dysgeusia. 
7.3 
Excluded Medications, Supplements, Dietary Products 
Concomitant medications will be prohibited as listed in the exclusion criteria in Section 7.2. 
After the first dose, acetaminophen (up to 2 g per 24-hour period) may be administered at the 
discretion of the Investigator or designee. Hormonal contraceptives (refer to Appendix D) and 
hormonal replacement medication may be permitted if the female participant has been on the 
same stable dose for at least 3 months prior to the first dose. 
If deviations occur, the Investigator or designee in consultation with the Sponsor if needed will 
decide on a case-by-case basis whether the participant may continue participation in the study. 
All medications taken by participants during the course of the study will be recorded. 
Use of excluded agents (prescription or non-prescription) or dietary products is outlined in  
Table 7.a and Section 7.4. 
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Table 7.a 
Excluded Medications, Supplements, and Dietary Products 
Category 
Prohibited Between Screening and the First 
Dosing (Day -28 to predose [Day 1 of 
Treatment Period 1]) 
Prohibited After the First 
Dosing (Day 1) to Follow-Up  
Alcohol 
From 48 hours prior to the first dosing. 
From the first dosing until the end 
of PK collection in Treatment 
Period 3 (Part 1) and Treatment 
Period 2 (Part 2). 
Xanthine and/or caffeine 
From 72 hours prior to the first dosing. 
Medications  
See Section 7.1and Section 7.2. 
See Section 7.1 and Section 7.2. 
Nicotine- and tobacco-
containing products 
From 3 months prior to the first dosing. 
From the first dosing until the end 
of PK collection in Treatment 
Period 3 (Part 1) and Treatment 
Period 2 (Part 2). 
Food 
Grapefruit/Seville orange 
From 14 days prior to the first dosing. 
From the first dosing until the end 
of PK collection in Treatment 
Period 3 (Part 1) and Treatment 
Period 2 (Part 2). 
Pine nuts 
From 7 days prior to the first dosing. 
7.4 
Diet, Fluid, Activity  
7.4.1 
Diet and Fluid 
Water (except water provided with each dosing) will be restricted between one hour prior to and 
one hour after each dosing, but will be allowed ad libitum at all other times. Other fluids may be 
given as part of meals and snacks but will be restricted at all other times throughout the 
confinement period. 
In Treatments A, B, and D, participants will fast overnight for at least 10 hours prior to dosing. 
Participants will continue the fast for at least four hours postdose. 
In Treatment C, participants will fast overnight for at least 10 hours until 30 minutes prior to 
their scheduled morning dose, when they will be given a high-fat/high-calorie meal, as presented 
in Table 7.b which will be entirely consumed within 25 minutes. Participants will fast for at least 
four hours postdose. 
In Treatment E, participants will fast overnight for at least 10 hours prior to maribavir dosing on 
Day 5. Participants will continue the fast for at least four hours post maribavir dose. For all other 
doses in Treatment Period 2, participants will be required to fast for at least one hour prior to 
rabeprazole dosing and until at least two hours after rabeprazole dosing. 
When confined, standard meals and snacks will be provided at appropriate times, except when 
they are required to fast. When confined in the CRU, participants will be required to fast from all 
food and drink (including gum, mints, etc). Only water will be allowed between meals and 
snacks. 
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Each meal and/or snacks served at the CRU will be standardized and will be similar in caloric 
content and composition (except for the meal served as part of Treatment C) and will be taken at 
approximately the same time in each treatment period. 
Table 7.b 
Examples of High-Fat/High-Calorie Meals and Breakdown of Calories and 
Contents 
 
High-Fat/High-Calorie Meal (Treatment C) 
Total calories (kCal) 
800-1000 
Protein calories (kCal) (% of total calories; 
weight) 
150 (19%; 38 grams)  
Carbohydrate calories (kCal) (% of total 
calories; weight) 
250 (31%; 63 grams) 
Fat calories (kCal) (% of total calories; 
weight) 
500-600 (50%; 55-65 grams) 
Example of breakfast 
• 
Eight ounces of whole milk 
• 
Two eggs fried in butter 
• 
Two strips of bacon 
• 
Two slices of toast with butter 
• 
Four ounces of hash brown potatoes 
(This meal’s fat content accounts for approximately 50% of total 
kCal) 
The high-fat/high-calorie meal proposed here for this study is based on FDA-recommended high-fat meal [13]. 
7.4.2 
Activity 
Participants will remain ambulatory or seated upright for the first four hours post maribavir dose, 
except when they are supine or semi reclined for study procedures. There is no posture restriction 
around the dosing of rabeprazole when administered alone. 
However, should AEs occur at any time, participants may be placed in an appropriate position or 
will be permitted to lie down on their right side. 
Participants will be instructed to refrain from strenuous physical activity which could cause 
muscle aches or injury, including contact sports at any time from screening until completion of 
the study. 
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7.5 
Criteria for Discontinuation or Withdrawal of a Participant 
The primary reason for discontinuation or withdrawal of the participant from the study or 
maribavir or rabeprazole dosing should be recorded in the case report form (CRF) using the 
following categories 
1. AE: The participant has experienced an AE that requires early termination because continued 
participation imposes an unacceptable risk to the participant’s health or the participant is 
unwilling to continue because of the AE. 
Liver Function Test (LFT) Abnormalities: 
Maribavir or rabeprazole should be discontinued immediately with appropriate clinical 
follow-up (including repeat laboratory tests, until a participant’s laboratory profile has 
returned to normal/baseline status, see Section 9.2.8), if the following circumstances 
occur at any time during treatment: 
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >8 × upper 
limit of normal (ULN), or  
• ALT or AST >5 × ULN and persists for more than two weeks, or  
• ALT or AST >3 × ULN in conjunction with elevated total bilirubin >2 × ULN, or  
• ALT or AST >3 × ULN with appearance of fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, fever, rash and/or eosinophilia (>5%). 
2. Significant protocol deviation: The discovery post-enrollment that the participant failed to 
meet protocol entry criteria or did not adhere to protocol requirements, and continued 
participation poses an unacceptable risk to the participant’s health. 
3. Lost to follow-up: Attempts to contact the participants were unsuccessful. Attempts to 
contact the participant must be documented in the participant’s source documents. 
4. Voluntary withdrawal: The participant (or participant’s legally acceptable representative) 
wishes to withdraw from the study. The reason for withdrawal, if provided, should be 
recorded in the CRF. 
Note: All attempts should be made to determine the underlying reason for the withdrawal 
and, where possible, the primary underlying reason should be recorded (ie, withdrawal due to 
an AE should not be recorded in the “voluntary withdrawal” category). If a participant 
chooses to withdraw from study participation due to personal concerns related to the 
Coronavirus disease 2019 (COVID-19) pandemic (other than a COVID-19-related AE), this 
should be specified as the reason for participant withdrawal in the CRF. 
5. Study termination: The Sponsor, Institutional Review Board (IRB), or regulatory agency 
terminates the study. 
6. Pregnancy: as described in Appendix D. 
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7. Participants may be withdrawn from the study by the Investigator or designee for the 
following reasons: 
• Difficulties in blood collection. 
• Positive urine drug or alcohol test. 
8. Other. The specific reasons for discontinuation should be entered into the CRF including 
unavoidable circumstances such as COVID-19. Participants may be withdrawn from the 
study at any time at the discretion of the Investigator or Sponsor for safety reasons which 
should be entered into the CRFs. 
7.6 
Procedures for Discontinuation or Withdrawal of a Participant 
The Investigator may discontinue a participant’s study participation at any time during the study 
when the participant meets the study termination criteria described in Section 7.5. In addition, a 
participant may discontinue his or her participation without giving a reason at any time during 
the study. Should a participant’s participation be discontinued, the primary criterion for 
termination must be recorded by the Investigator. In addition, efforts should be made to perform 
all procedures scheduled for the end-of-study or early termination as described in Section 3.0. 
7.7 
Participant Replacement 
Replacement of discontinued or withdrawn participants due to any reason will be assessed on a 
case-by-case basis by the Sponsor and Investigator to ensure a minimum of 12 PK-evaluable 
participants complete the study in each study part. 
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8.0 
CLINICAL STUDY MATERIAL MANAGEMENT 
8.1 
Clinical Investigational Drug 
Product Name: 
Maribavir (TAK-620) 
Strength: 
200-mg 
Dose: 
200 mg 
Dosage Form/Formulation: 
Tablet (commercial formulation) 
Pediatric powder-for-oral suspension formulation 
Dosing Regimen: 
Single dose 
Route of Administration: 
Oral 
Interacting Drug (Part 2 only) 
Product Name:  
 
Rabeprazole 
Strength:  
 
20-mg 
Dose:  
 
20 mg 
Dosage Form/Formulation:   
Tablet 
Dosing regimen:  
Multiple dose (QD) 
Route of Administration:  
Oral 
Preference for generic or brand name:  
Generic. 
8.1.1 
Clinical Study Drug Labeling 
Maribavir and rabeprazole containers will be affixed with a clinical label in accordance with 
local regulatory requirements. 
8.1.2 
Clinical Study Drug Inventory and Storage 
The Sponsor will supply sufficient quantities of maribavir to allow completion of this study. 
Celerion will supply sufficient quantities of rabeprazole to allow completion of this study 
(Part 2). 
The same lot number will be used throughout the study. The lot numbers and expiration dates 
(where available) of the study drugs supplied will be recorded in the final report. Study drugs 
will be stored according to the product labels provided with the product. 
Records will be made of the receipt, preparation, dispensing, and final disposition of the study 
drugs supplied. 
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8.1.3 
Clinical Study Drug Blinding 
This is an open-label study.  
8.1.4 
Randomization Code Creation and Storage (Part 1) 
In Part 1, a computerized randomization scheme will be created by a Celerion statistician. 
Treatments A, B, and C will be randomized to one of six sequences as indicated in Table 8.a. 
Table 8.a 
Randomization Sequences in Part 1 
Sequences 
Number of participants (N) 
Treatment 
Period 1 
Treatment 
Period 2 
Treatment 
Period 3 
1 
3 
A 
B 
C 
2 
3 
A 
C 
B 
3 
3 
B 
A 
C 
4 
3 
B 
C 
A 
5 
3 
C 
A 
B 
6 
3 
C 
B 
A 
Treatment A: Maribavir single dose (200 mg) administered as commercial tablet under fasting conditions. 
Treatment B: Maribavir single dose (200 mg) administered as powder-for-oral suspension under fasting conditions. 
Treatment C: Maribavir single dose (200 mg) administered as powder-for-oral suspension under fed conditions. 
8.1.5 
Assignment to Treatments (Part 2) 
Each participant will be assigned a unique identification number upon at the screening visit. 
Participants who complete the study screening assessments and meet all the eligibility criteria 
will be assigned a unique identification number, different from the screening number, and will 
receive the corresponding product.  
Participants will receive each treatment on one occasion. 
8.1.6 
Clinical Study Blind Maintenance/Unblinding Procedure 
Not applicable 
8.1.7 
Accountability and Destruction of Sponsor-Supplied Drugs 
Records will be made of the receipt and dispensing of the study drugs supplied. At the 
conclusion of the study, any unused study drug will be retained by Celerion, returned to the 
Sponsor or designee, or destroyed, as per Sponsor instructions. If no supplies remain, this fact 
will be documented in the pharmacy product accountability records. 
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9.0 
STUDY PROCEDURES 
9.1 
Administrative Procedures 
9.1.1 
Informed Consent Procedure 
The purpose of the study, the procedures to be carried out and the potential hazards will be 
described to the participants in non-technical terms. Participants will be required to read, sign, 
and date an ICF, and will be assured that they may withdraw from the study at any time without 
jeopardizing their medical care. 
Participants will be given a copy of their signed ICF. 
9.1.1.1 
Assignment of Screening and Randomization Numbers  
Each participant will be assigned a unique identification number upon screening. Participants 
who complete the study screening assessments and meet all the eligibility criteria will be 
assigned a unique randomization identification number at the time of the first dose, different 
from the screening number and will receive the corresponding product, according to a 
randomization sequence (Section 8.1.4). 
If replacement participants are used, the replacement participant number will be 100 more than 
the original (eg, Participant No. 1201 will replace Participant No. 1101). 
9.1.1.2 
Study Drug Assignment 
All participants will receive the treatments as detailed in Section 8.1. 
9.1.2 
Inclusion and Exclusion  
Please refer to Section 7.1 and Section 7.2. 
9.1.3 
Medical History/Demography 
Medical history and demographic data, including name, sex, age, race, ethnicity, and history of 
tobacco use will be recorded. 
9.1.4 
Concomitant Medications 
Concomitant medications will be prohibited as listed in Section 7.3. All medications taken by 
participants during the course of the study will be recorded. 
9.2 
Clinical Procedures and Assessments 
The Schedule of Study Procedures (Section 3.0) summarizes the clinical procedures to be 
performed at each visit. Individual clinical procedures are described in detail below. Additional 
evaluations/testing may be deemed necessary by the Investigator or designee and/or the Sponsor 
for reasons related to participant safety. 
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For this study, collection of blood for maribavir PK is the critical parameter and needs to be 
collected as close to the exact time point as possible. All other procedures should be completed 
as close to the prescribed/scheduled time as possible, but can be performed prior to or after the 
prescribed/scheduled time. 
Any nonscheduled procedures required for urgent evaluation of safety concerns take precedence 
over all routine scheduled procedures. 
9.2.1 
Full Physical Exam 
A full physical examination will be performed as outlined in the Schedule of Study Procedures 
(Section 3.0). Additional physical examinations may be performed at other times, if deemed 
necessary by the Investigator or designee. 
9.2.2 
Height and Weight 
Body height (cm) and weight (kg) will be reported as outlined in the Schedule of Study 
Procedures (Section 3.0). 
9.2.3 
BMI 
BMI will be calculated based on the height and weight measured at screening. 
9.2.4 
Vital Signs 
Single measurements of temperature, respiration rate, blood pressure, and pulse rate, will be 
measured as outlined in the Schedule of Study Procedures (Section 3.0). Additional vital signs 
may be taken at any other times, if deemed necessary. 
Blood pressure and pulse rate measurements will be performed with participants in a supine 
position, except when they are semi-reclined because of study procedures and/or AEs 
(eg, nausea, dizziness) or if deemed necessary by the Investigator or designee. Participants 
should be in the appropriate position for at least five minutes prior to obtaining vital signs. 
Blood pressure and pulse rate will be measured within two hours prior to Day 1 dosing in each 
treatment period for the predose time point. At all other predose time points, vital signs will be 
collected within two hours prior to dosing. When scheduled postdose, vital signs will be 
performed within approximately 15 minutes of the scheduled time point.  
9.2.5 
12-Lead ECG 
Single 12-lead ECGs will be performed as outlined in the Schedule of Study Procedures 
(Section 3.0). Additional ECGs may be taken at any other times, if deemed necessary by the 
Investigator or designee. 
At screening, if QTc exceeds 450 msec, the ECG should be repeated two more times and the 
average of the three QTc values should be used to determine the participant’s eligibility. 
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ECGs will be performed with participants in a supine position. All ECG tracings will be 
reviewed by the Investigator or designee. The participant must be resting in the supine position 
for at least five minutes prior to collecting the ECG. 
At all predose time points, ECGs will be collected within two hours prior to dosing. When 
scheduled postdose, ECGs will be performed within approximately 20 minutes of the scheduled 
time point. 
9.2.6 
Study Drug Administration 
The study drugs will be provided as described in Section 8.1. 
Treatments are described in Table 2.c. 
The pharmacy at the CRU will provide each dose in individual unit dose containers for each 
participant, as appropriate. 
All tablets will be administered with approximately 240 mL of water. When maribavir pediatric 
powder-for-oral suspension formulation is administered, a total of approximately 240 mL of 
water will be used, taking into account the volume of maribavir pediatric powder-for-oral 
suspension (20 mL) as described in the pharmacy manual. 
Participants will be instructed not to crush, split, or chew the tablets. 
Dosing should occur at approximately the same time in each treatment period. For Treatment C, 
a meal will be provided 30 minutes prior to dosing. For Treatment E, doses of rabeprazole on 
Days 2-5 will be administered ±1 hour of the time of rabeprazole dosing on Day 1. 
The exact clock time of dosing will be recorded. 
A qualified designee will be responsible for monitoring the administration of the assigned doses. 
For tablets, a mouth check will be performed by the qualified designee to ensure that the 
participants have swallowed the study drugs. Once a participant has finished the dosing water, 
the qualified designee will use a flashlight and a tongue depressor to check the participant’s 
mouth. Participant’s hands will also be verified to ensure that the study drug was ingested. 
9.2.7 
AE Monitoring 
Participants will be monitored throughout the study for TEAEs and/or procedures as described in 
Section 10.0. 
9.2.8 
Laboratory Procedures and Assessments 
All tests listed below will be performed as outlined in the Schedule of Study Procedures 
(Section 3.0). In addition, laboratory safety tests may be performed at various unscheduled time 
points, if deemed necessary by the Investigator or designee. 
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9.2.8.1 
Clinical Laboratory Tests 
Hematology 
Hematology will consist of the following tests: 
Hemoglobin 
Red blood cell count 
Hematocrit  
Platelet count 
Total and differential leukocyte count 
 
 
Chemistry  
Serum chemistry tests will be performed after at least an 8-hour fast; however, in case of 
dropouts or rechecks, participants may not have fasted for 8 hours prior to when the serum 
chemistry sample being taken. 
Chemistry evaluations will consist of the following standard chemistry panel: 
Blood Urea Nitrogen 
Albumin 
Bilirubin (total and direct) 
Sodium 
Alkaline phosphatase 
Potassium 
AST 
Chloride 
ALT 
Glucose (fasting) 
FT4 ** 
Creatinine * 
TSH ** 
 
* At screening, creatinine clearance will be calculated using the Cockcroft-Gault formula. 
** At screening only 
Urinalysis  
Urinalysis will consist of the following tests: 
pH 
Bilirubin 
Specific gravity 
Blood * 
Protein * 
Nitrite * 
Glucose 
Urobilinogen 
Ketones 
Leukocyte esterase * 
* If urinalysis is positive for protein, blood, nitrite and/or leukocyte esterase, a microscopic examination (for red 
blood cells, white blood cells, bacteria, casts, and epithelial cells) will be performed. 
 
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Other  
HIV test 
Urine drug screen 
- 
Opiates (includes morphine, heroin 
[diacetylmorphine], codeine, 6-acetylmorphine, 
dihydrocodeine, hydrocodone, thebaine, and, 
hydromorphone) 
- 
Amphetamines 
- 
Barbiturates 
- 
Benzodiazepines 
- 
Cocaine 
- 
Cannabinoids 
- 
Methadone 
- 
Phencyclidine 
HBsAg 
HCV 
Urine alcohol screen 
Serum pregnancy test (for females only) 
Follicle stimulating hormone (FSH; for 
postmenopausal females only) 
COVID-19 (Severe acute respiratory syndrome-
Coronavirus-1 [SARS-CoV-2] polymerase chain 
reaction test or equivalent) 
9.3 
PK Samples 
Samples for maribavir PK assessment will be collected as outlined in the Schedule of Study 
Procedures (Section 3.0). 
Instructions for PK sample collection, processing, and shipping will be provided in separate 
documents.  
Primary specimen collection parameters are provided in Table 9.a and allowed windows for PK 
sample collection are provided in Table 9.b. 
Table 9.a 
Primary Specimen Collections 
Specimen Name 
Primary 
Specimen 
Primary 
Specimen 
Derivative 
Description of Intended Use 
Sample 
Collection 
Plasma sample for PK 
Blood 
Plasma 
Plasma sample for PK analysis 
Mandatory 
Table 9.b 
PK Sampling Collection Window 
Sample Collection Time 
Sampling Window 
Predose 
< -1 hour 
>0 - ≤4 hours postdose 
± 5 minutes 
>4 - ≤24 hours postdose 
± 15 minutes 
 
9.3.1 
PK Measurements  
Samples from all participants will be analyzed even if the participants do not complete the study. 
Samples for determination of maribavir in plasma will be analyzed using validated bioanalytical 
methods. 
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PK parameters of maribavir will be calculated from the individual concentration-time profiles 
from all evaluable participants using NCA methods. Actual sampling times, rather than 
scheduled sampling times, will be used in all computations involving sampling times.  
9.3.1.1 
Plasma for PK Measurements 
The following PK parameters will be calculated from plasma concentrations of maribavir, unless 
otherwise specified: 
AUClast: 
Area under the concentration-time curve from time 0 to the time of the 
last quantifiable concentration. 
AUC∞: 
Area under the concentration-time curve from time 0 to infinity, 
calculated using the observed value of the last quantifiable concentration. 
AUC12h: 
Area under the concentration-time curve from time 0 to 12 hours 
postdose. 
AUCextrap%: 
Area under the curve from the last quantifiable concentration to infinity, 
calculated using the observed value of the last quantifiable concentration, 
expressed as a percentage of AUC∞. 
CL/F: 
Apparent clearance after oral administration, calculated using the 
observed value of the last quantifiable concentration. 
Cmax: 
Maximum observed concentration. 
C12h: 
Concentration at 12 hours postdose. 
Cτ: 
Projected trough concentration at 12 hours postdose after BID dosing. 
tmax: 
Time to first occurrence of Cmax. 
tlag: 
Lag time to first quantifiable concentration in plasma. 
λz: 
Terminal disposition phase rate constant. 
t½z: 
Terminal disposition phase half-life. 
Vz/F: 
Apparent volume of distribution during the terminal disposition phase 
after oral administration, calculated using the observed value of the last 
quantifiable concentration. 
No value for AUC∞, AUCextrap%, CL/F, Vz/F, λz, or t½z will be reported for cases that do not 
exhibit a terminal log-linear phase in the concentration versus time profile. 
PK parameters will not be calculated for subjects with less than five consecutive postdose time 
points with quantifiable concentrations. 
Additional PK parameters may be estimated as appropriate. 
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9.3.2 
Biomarker Measurements  
Not applicable. 
9.3.3 
PGx Measurements  
Not applicable. 
9.4 
Palatability 
In Part 1, all participants who receive the maribavir pediatric formulation will undergo a 
palatability assessment as outlined in the Schedule of Study Procedures (Section 3.0). 
Each participant performing the palatability evaluation will verbally respond to a series of 
questions asked by a trained clinical staff member utilizing the participant’s fluent language 
(ie, English or U.S. Spanish). Participant will be isolated from other participants during the 
evaluation session and will be asked not to talk amongst themselves to discuss results to not 
influence their responses. 
9.5 
Confinement 
Participants will be housed on Day -1 of Treatment Period 1, at the time indicated by the CRU, 
until completion of study procedures on Day 2 of Treatment Period 3 (Part 1) and Day 6 of 
Treatment Period 2 (Part 2) as outlined in the Schedule of Study Procedures (Section 3.0). 
At all times, a participant may be required to remain at the CRU for longer at the discretion of 
the Investigator or designee. 
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10.0 
ADVERSE EVENTS 
10.1 
Definitions and Elements of AEs 
An AE is defined as any untoward medical occurrence in a clinical investigation participant who 
has signed informed consent to participate in a study; it does not necessarily have to have a 
causal relationship with the treatment. 
An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant 
abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, 
whether or not it is considered related to the drug. 
An untoward finding generally may: 
• Indicate a new diagnosis or unexpected worsening of a preexisting condition. 
(Intermittent events for pre-existing conditions or underlying disease should not be 
considered AEs.) 
• Necessitate therapeutic intervention. 
• Require an invasive diagnostic procedure. 
• Require discontinuation or a change in dose of maribavir or rabeprazole or a 
concomitant medication. 
• Be considered unfavorable by the Investigator for any reason. 
Diagnoses versus signs and symptoms: 
• Each event should be recorded to represent a single diagnosis. Accompanying signs 
(including abnormal laboratory values or ECG findings) or symptoms should NOT 
be recorded as additional AEs. If a diagnosis is unknown, sign(s) or symptom(s) 
should be recorded appropriately as an AE(s). 
Laboratory values and ECG findings: 
• Changes in laboratory values or ECG parameters maybe considered AEs if they are 
judged to be clinically significant (ie, if some action or intervention is required or if 
the Investigator judges the change to be beyond the range of normal physiologic 
fluctuation). A laboratory re-test and/or continued monitoring of an abnormal value 
are not considered an intervention. In addition, repeated or additional noninvasive 
testing for verification, evaluation or monitoring of an abnormality is not considered 
an intervention. 
• If abnormal laboratory values or ECG findings are the result of pathology for which 
there is an overall diagnosis (eg, increased creatinine in renal failure), the diagnosis 
only should be reported appropriately as an AE. 
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Pre-existing conditions: 
• A pre-existing condition (present at the time of signing of informed consent) is 
considered a concurrent medical history condition and should NOT be recorded as 
an AE. A baseline evaluation (eg, laboratory test, ECG, X-ray, etc.) should NOT be 
recorded as an AE unless related to a study procedure. However, if the participant 
experiences a worsening or complication of such a concurrent medical history 
condition, the worsening or complication should be recorded appropriately as an AE 
(worsening or complication occurs after informed consent is signed). Investigators 
should ensure that the event term recorded captures the change in the condition 
(eg, “worsening of…”). 
• If a participant has a pre-existing episodic condition (eg, asthma, epilepsy), any 
occurrence of an episode should only be captured as an AE if the episodes become 
more frequent, serious, or severe in nature, that is, Investigators should ensure that 
the AE term recorded captures the change from Baseline in the condition 
(eg, “worsening of…”). 
• If a participant has a degenerative concurrent condition (eg, cataracts, rheumatoid 
arthritis), worsening of the condition should only be captured as an AE if occurring 
to a greater extent to that which would be expected. Again, Investigators should 
ensure that the AE term recorded captures the change in the condition 
(eg, “worsening of…”). 
Worsening of AEs: 
• If the participant experiences a worsening or complication of an AE after the first 
administration of maribavir or rabeprazole or after any change in study drug, the 
worsening or complication should be recorded as a new AE. Investigators should 
ensure that the AE term recorded captures the change in the condition 
(eg, “worsening of…”). 
Changes in severity of AEs: 
• If the participant experiences a change in the severity of an AE that is not associated 
with a change in study drug, the event should be captured once with the maximum 
severity recorded. 
Preplanned surgeries or procedures: 
• Preplanned procedures (surgeries or therapies) that were scheduled prior to signing 
of informed consent are not considered AEs. However, if a preplanned procedure is 
performed early (eg, as an emergency) due to a worsening of the pre-existing 
condition, the worsening of the condition should be captured appropriately as an AE. 
Complications resulting from any planned surgery should be reported as AEs. 
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Elective surgeries or procedures: 
• Elective procedures performed where there is no change in the participant’s medical 
condition should not be recorded as AEs but should be documented in the 
participant’s source documents. Complications resulting from an elective surgery 
should be reported as AEs. 
Overdose: 
• An overdose is defined as a known deliberate or accidental administration of 
ID/study drug, to or by a study participant, at a dose above that which is assigned to 
that individual participant according to the study protocol. It is up to the Investigator 
or the reporting physician to decide whether a dose is to be considered an overdose, 
in consultation with the Sponsor. 
• All cases of overdose (with or without associated AEs) will be documented on an 
Overdose page of the (e)CRF, in order to capture this important safety information 
consistently in the database. AEs associated with an overdose will be documented on 
AE CRF(s) according to Section 10.0. 
• Serious adverse events (SAEs) of overdose should be reported according to the 
procedure outlined in Section 10.2.8. 
• In the event of drug overdose, the participant should be treated symptomatically. 
10.1.1 
SAEs 
An SAE is defined as any untoward medical occurrence that at any dose: 
1. Results in DEATH. 
2. Is LIFE THREATENING. 
• The term “life threatening” refers to an event in which the participant was at risk of death 
at the time of the event; it does not refer to an event that hypothetically might have 
caused death if it were more severe. 
3. Requires inpatient HOSPITALIZATION or prolongation of existing hospitalization. 
4. Results in persistent or significant DISABILITY/INCAPACITY. 
5. Is a CONGENITAL ANOMALY/BIRTH DEFECT. 
6. Is an IMPORTANT MEDICAL EVENT that satisfies any of the following: 
• May require intervention to prevent items 1 through 5 above. 
• May expose the participant to danger, even though the event is not immediately life 
threatening or fatal or does not result in hospitalization. 
COVID-19-related disease and COVID-19 pneumonia should be reported as Medically 
Significant AE. 
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AEs that fulfill one or more of the serious criteria above are to be considered SAEs and should 
be reported and followed up in the same manner (see Section 10.1 and Section 10.1.1). 
10.1.2 
Adverse Events of Special Interest 
Adverse events of special interest (AESIs) for maribavir include: 
• Dysgeusia 
• GI-related events (ie, nausea, vomiting, and diarrhea). 
10.2 
AE Procedures 
10.2.1 
Assigning Severity/Intensity of AEs 
The different categories of severity/intensity are: 
Mild: 
An AE that is usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with usual 
activities of daily living. 
Moderate: 
An AE that is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, 
causing discomfort but poses no significant or permanent risk of harm to the 
research participant. 
Severe: 
An AE that interrupts usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention. 
10.2.2 
Assigning Causality of AEs 
The relationship of each AE to the study drug will be assessed using the following categories: 
 
Related: 
An AE that follows a reasonable temporal sequence from administration of a 
drug (including the course after withdrawal of the drug), or for which a 
causal relationship is at least a reasonable possibility, ie, the relationship 
cannot be ruled out, although factors other than the drug, such as underlying 
diseases, complications, concomitant drugs and concurrent treatments, may 
also be responsible. 
Not Related: 
An AE that does not follow a reasonable temporal sequence from 
administration of a drug and/or that can reasonably be explained by other 
factors, such as underlying diseases, complications, concomitant medications 
and concurrent treatments. 
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In addition, relationship (causality) to COVID-19 should be determined for all AEs. The 
relationship should be assessed as related if the Investigator considers that there is reasonable 
possibility that an event is due to COVID-19. Otherwise, the relationship should be assessed as 
not related. 
Similarly, relationship (causality) to COVID-19 vaccines should be determined for all AEs. The 
relationship should be assessed as related if the Investigator considers that there is reasonable 
possibility that an event is due to COVID-19 vaccines. Otherwise, the relationship should be 
assessed as not related. If the AE has relationship to vaccination, specific verbatim term should 
be used, eg, post-vaccination fever, vaccination site burning. 
In addition, if the causality assessment done by the Investigator determines that AEs are related 
or possible related to COVID-19 or the COVID-19 vaccine, the events should be assessed as not 
related to the study drug. If the AE is related to COVID-19 vaccination, specific verbatim 
term(s) should be used, eg, post-vaccination fever, vaccination site burning. 
10.2.3 
Start Date  
The start date of the AE is the date that the first signs/symptoms were noted by the participant 
and/or Investigator. 
10.2.4 
End Date  
The end date of the AE is the date at which the participant recovered, the event resolved but with 
sequelae or the participant died. 
10.2.5 
Pattern of Adverse Event (Frequency)  
Episodic AEs (eg, headache) or those which occur repeatedly over a period of consecutive days 
are intermittent. All other events are continuous. 
10.2.6 
Action Taken With Study Treatment 
• Drug withdrawn – the study drug is stopped due to the particular AE. 
• Dose not changed – the particular AE did not require stopping the study drug 
• Unknown – only to be used if it has not been possible to determine what action has 
been taken. 
• Not applicable – the study drug was stopped for a reason other than the particular 
AE eg, the study has been terminated, the participant died, dosing with the study 
drug had not yet started or dosing with the study drug was already stopped before the 
onset of the AE. 
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10.2.7 
Outcome  
• Recovered/resolved – participant returned to first assessment status with respect to 
the AE. 
• Recovering/resolving – the intensity is lowered by one or more stages: the diagnosis 
has or signs/symptoms have almost disappeared; the abnormal laboratory value 
improved, but has not returned to the normal range or to the baseline value; the 
participant died from a cause other than the particular AE with the condition 
remaining “recovering/resolving.” 
• Not recovered/not resolved – there is no change in the diagnosis, signs or symptoms; 
the intensity of the diagnosis, signs/symptoms or laboratory value on the last day of 
the observed study period has become worse than when it started; is an irreversible 
congenital anomaly; the participant died from another cause with the particular AE 
state remaining “Not recovered/not resolved.” 
• Recovered/resolved with sequelae – the participant recovered from an acute AE but 
was left with permanent/significant impairment (eg, recovered from a cardiovascular 
accident but with some persisting paresis). 
• Fatal – an AE that is considered as the cause of death. 
• Unknown – the course of the AE cannot be followed up due to hospital change or 
residence change at the end of the participant’s participation in the study. 
10.2.8 
Collection and Reporting of AEs, SAEs, AESIs, and Abnormal LFTs 
10.2.8.1 
Collection Period 
Collection of AEs (ie, AEs, SAEs, AESIs, and Abnormal LFTs) will commence at the time the 
participant signs the informed consent. Routine collection of AEs will continue until the 
follow-up contact on Day 7 (±4) days, after the last dose. For participants who discontinue prior 
to the administration of the study drug, AEs will be followed until the participant discontinues 
study participation.  
10.2.8.2 
Reporting AEs 
At each treatment period, the Investigator will assess whether any subjective AEs have occurred. 
A neutral question, such as “How have you been feeling?” may be asked. Participants may report 
AEs occurring at any other time during the study. Participants experiencing an SAE prior to the 
first exposure to maribavir must be monitored until the symptoms subside and any clinically 
relevant changes in laboratory values have returned to Baseline or there is a satisfactory 
explanation for the change. Nonserious AEs that begin prior to the first exposure to the study 
drug, related or unrelated to the study procedure, need not be followed-up for the purposes of the 
protocol. 
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All participants experiencing AEs, whether considered associated with the use of the study drug 
or not, must be monitored until the symptoms subside and any clinically relevant changes in 
laboratory values have returned to Baseline or until there is a satisfactory explanation for the 
changes observed. All AEs will be documented in the AE page of the CRF, whether or not the 
Investigator concludes that the event is related to the drug treatment. The following information 
will be documented for each event: 
• Event term. 
• Start and end date and time. 
• Pattern of AE (frequency). 
• Severity/Intensity. 
• Causality (Investigator’s opinion of the causal relationship between the event and 
administration of the study drug). 
• Relationship to COVID-19. 
• Relationship to COVID-19 vaccine. 
• Action taken with study drug. 
• Outcome of event. 
• Seriousness. 
10.2.8.3 
Reporting SAEs 
When an SAE occurs through the AE collection period it should be reported according to the 
procedure outlined below: 
A Takeda SAE form must be completed, in English and signed by the Investigator immediately 
or within 24 hours of first onset or notification of the event. The information should be 
completed as fully as possible but contain, at a minimum: 
• A short description of the event and the reason why the event is categorized as 
serious. 
• Participant identification number. 
• Investigator’s name. 
• Name of the study drug. 
• Causality assessment. 
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The SAE form should be transmitted within 24 hours to the attention of the contact listed in 
Section 14.1.1. 
Any SAE spontaneously reported to the Investigator following the AE collection period should 
be reported to the Sponsor if considered related to study participation. 
Reporting of SAEs that begin before first administration of the study drug will follow the same 
procedure for SAEs occurring on treatment. 
SAE Follow-Up 
If information is not available at the time of the first report becomes available at a later date, the 
Investigator should complete a follow-up SAE form or provide other written documentation and 
fax it immediately within 24 hours of receipt. Copies of any relevant data from the hospital notes 
(eg, ECGs, laboratory tests, discharge summary, postmortem results) should be sent to the 
addressee, if requested. 
All SAEs should be followed up until resolution or permanent outcome of the event. The 
timelines and procedure for follow-up reports are the same as those for the initial report. 
10.2.8.4 
Reporting AESIs  
AESIs for maribavir include dysgeusia and GI-related events (ie, nausea, vomiting, and 
diarrhea). 
10.2.8.5 
Reporting of Abnormal LFTs 
If a participant is noted to have ALT or AST elevated >3×ULN on 2 consecutive occasions, the 
abnormality should be recorded as an AE. In addition, an LFT Increases CRF must be completed 
providing additional information on relevant recent history, risk factors, clinical signs and 
symptoms and results of any additional diagnostic tests performed. 
If a participant is noted to have ALT or AST >3×ULN and total bilirubin >2×ULN for which an 
alternative etiology has not been identified, the event should be recorded as an SAE and reported 
as per Section 10.2.8.3. The Investigator must contact the Medical Monitor to discuss the 
relevant participant details and possible alternative etiologies, such as acute viral hepatitis A or B 
or other acute liver disease. Follow-up laboratory tests as described in Section 9.2.8 must also be 
performed. In addition, an LFT Increases CRF must be completed and transmitted with the 
Takeda SAE form (as per Section 10.2.9).  
10.2.9 
Safety Reporting to Investigators, IRBs, and Regulatory Authorities  
The Sponsor will be responsible for reporting all suspected unexpected serious adverse reactions 
(SUSARs) and any other applicable SAEs to regulatory authorities, Investigators, and IRBs in 
accordance with national regulations. Relative to the first awareness of the event by/or further 
provision to the Sponsor or Sponsor’s designee, SUSARs will be submitted within 7 days for 
fatal and life-threatening events and 15 days for other serious events, unless otherwise required 
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by national regulations. The Sponsor will also prepare an expedited report for other safety issues 
where these might materially alter the current benefit-risk assessment of an ID or that would be 
sufficient to consider changes in the ID administration or in the overall conduct of the study. The 
investigational site also will forward a copy of all expedited reports to his or her IRB in 
accordance with national regulations. 
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11.0 
STATISTICAL METHODS 
11.1 
Statistical and Analytical Plans 
Detailed methodology for data summary and statistical analyses of the data collected in this 
study will be documented in a statistical analysis plan (SAP). The SAP will be prepared by 
Celerion and agreed upon with the Sponsor. This document may modify the plans outlined in the 
protocol; however, any major modifications of the primary endpoints definition and/or its 
analysis will also be reflected in a protocol amendment. Additional statistical analyses other than 
those described in this section may be performed if deemed appropriate. 
11.1.1 
Analysis Sets 
11.1.1.1 
PK Set 
All participants who received at least one dose of maribavir, did not vomit or had diarrhea within 
four hours of the maribavir dosing, and have five or more postdose time points with evaluable 
postdose maribavir concentration values that enable NCA will be included in PK set. 
11.1.1.2 
Safety Set 
All participants who received at least one dose of maribavir will be included in the safety 
evaluations. 
11.1.1.3 
Palatability Set (Part 1 only) 
All participants who received at least one dose of maribavir pediatric formulation and have 
provided at least one response to the palatability questionnaire will be included in the Palatability 
Set. 
11.1.2 
Analysis of Demography and Other Baseline Characteristics 
Continuous demographic data (ie, age, weight, height, and BMI) will be listed and summarized 
using appropriate summary statistics. Categorical demographic data (ie, gender, race, and 
ethnicity) will also be listed and tabulated. 
11.1.3 
PK Analysis 
PK analysis will be based on the PK set. For both Part 1 and Part 2 of the study, individual 
maribavir plasma concentrations and PK parameters will be listed by participant and treatment 
and summarized by treatment (maribavir plasma concentrations and PK parameters) and nominal 
time (maribavir plasma concentrations). PK parameters (including but not limited to AUClast, 
AUC∞, Cmax, AUCextrap%, AUC12h, tmax, λz, CL/F, Vz/F, tlag, t½z, C12h, and Cτ) will be computed 
using standard NCA analysis. Additionally, the primary PK endpoints will be descriptively 
analyzed, and graphically displayed. Selected plasma PK parameters may be statistically 
analyzed, if appropriate. PK analysis will be fully specified in the CPAP. 
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Part 1 – Relative bioavailability and food effect estimation 
This analysis will be based on the PK set (Part 1 data).  
A mixed-effects model will be applied to log-transformed Cmax, AUClast, and AUC∞ with 
treatment, period and sequence as fixed effects, and participant within sequence as a random 
effect. Point estimates and their associated 90% CIs will be constructed for the differences 
between Treatment B (test) versus Treatment A (reference), and Treatment C (test) versus 
Treatment B (reference). The point estimates and their associated 90% CIs will be then back 
transformed to provide point estimates and 90% CIs for the ratios of Treatment B (test) versus 
Treatment A (reference), and Treatment C (test) versus Treatment B (reference).  
Additionally, analysis of tmax and tlag will be performed by nonparametric Wilcoxon Signed-Rank 
test. 
Part 2 – PPI effect estimation 
This analysis will be based on the PK set (Part 2 data). 
A mixed-effects model will be applied to log-transformed Cmax, AUClast, and AUC∞ with 
treatment as a fixed effect, and participant as a random effect. Point estimates and their 
associated 90% CIs will be constructed for the differences between Treatment E (test) versus 
Treatment D (reference). The point estimates and their associated 90% CIs will be then back 
transformed to provide point estimates and 90% CIs for the ratios of Treatment E (test) versus 
Treatment D (reference). 
Additionally, analysis of tmax and tlag will be performed by nonparametric Wilcoxon Signed-Rank 
test. 
11.1.4 
Pharmacodynamic Analysis 
Not applicable. 
11.1.5 
Safety Analysis 
Dosing dates and times will be listed by participant. 
Safety analysis will be based on safety data set. 
TEAEs will be tabulated. Quantitative safety data as well as the difference to baseline, when 
appropriate, will be summarized using the appropriate descriptive statistics. 
11.1.5.1 
AEs 
AEs will be coded using the most current version of Medical Dictionary for Regulatory 
Activities® (MedDRA®) available at Celerion and summarized by treatment for the number of 
participants reporting the TEAE and the number of TEAEs reported. Summaries in terms of 
severity, seriousness, and relationship to maribavir and/or rabeprazole will also be provided. 
Treatment-emergent SAEs and AESIs will be summarized separately in a similar fashion. A 
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by-participant AE data listing including verbatim term, coded term, treatment, severity, and 
relationship to treatment will be provided. 
TEAEs are defined as those with a start date on or after the first dose, or with a start date before 
the date of first dose of maribavir but increasing in severity after the first dose. 
11.1.5.2 
Clinical Laboratory Evaluation 
Clinical laboratory results will be summarized by treatment and point of collection time and a 
shift table describing out of normal range shifts will be provided. 
Individual results meeting PCS criteria for safety clinical laboratory assessments will be listed 
and summarized. The number and percentages of participants with at least one postdose result 
considered as a PCS will be provided. More detail will be provided in the SAP. 
11.1.5.3 
Vital Signs 
Vital signs assessments will be summarized by treatment and point of time of collection. 
Vital signs results meeting PCS criteria for vital signs assessments will be listed and 
summarized. The number and percentages of participants with at least one postdose result 
considered as a PCS will be provided. More detail will be provided in the SAP. 
11.1.5.4 
Other Safety Parameters 
ECGs will be summarized by treatment and point of time of collection. ECG results meeting 
PCS criteria for safety ECGs will be listed and summarized. The number and percentages of 
participants with at least one postdose result considered as a PCS will be provided. More detail 
will be provided in the SAP. 
Medical history, including concurrent conditions, will be coded using the MedDRA® and 
concomitant medications will be coded using the World Health Organization (WHO) drug 
dictionary and will be summarized by treatment. 
11.1.6 
Exploratory Analysis 
In Part 1, palatability data collected from the palatability questionnaire will be summarized 
descriptively using the Palatability Set for Treatments B and C (pediatric formulation) only. 
Percentages will be reported, based on the number of participants in the Palatability Set with any 
response to the corresponding question in each treatment. 
Additional exploratory analyses may be conducted and reported separately. 
11.2 
Interim Analysis and Criteria for Early Termination 
Not applicable. 
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12.0 
QUALITY CONTROL AND QUALITY ASSURANCE 
12.1 
Study-Site Monitoring Visits 
Monitoring visits to the study site will be made periodically during the study to ensure that all 
aspects of the protocol are followed. Due to COVID-19, monitoring visits may also be conducted 
remotely. Source documents will be reviewed for verification of data recorded on the CRFs. 
Source documents are defined as original documents, data, and records. The Investigator and 
study site guarantee access to source documents by the Sponsor or its designee and by the IRB. 
All aspects of the study and its documentation will be subject to review by the Sponsor or the 
Sponsor’s designee (as long as blinding is not jeopardized), including but not limited to the 
Investigator’s Binder, study drug, participant medical records, informed consent documentation, 
and review of CRFs and associated source documents. It is important that the Investigator and 
other study personnel are available during the monitoring visits and that sufficient time is 
devoted to the process. 
12.2 
Protocol Deviations 
The Investigator or study personnel should not deviate from the protocol, except where necessary 
to eliminate an immediate hazard to study participants. Should other unexpected circumstances 
arise that will require deviation from protocol-specified procedures, the Investigator should 
consult with the sponsor or designee (and IRB) to determine the appropriate course of action. 
There will be no exemptions (a prospectively approved deviation) from the inclusion or 
exclusion criteria. 
For COVID-19-related protocol deviations, the specific protocol deviation, the reason for the 
deviation, and the relationship to COVID-19 should be documented using CRU standard 
processes. 
Significant deviations include, but are not limited to, those that involve fraud or misconduct, 
increase the health risk to the participant, or confound interpretation of primary study 
assessment.  
12.3 
Quality Assurance Audits and Regulatory Agency Inspections 
The study site also may be subject to quality assurance audits by the Sponsor or designees. In 
this circumstance, the Sponsor-designated auditor will contact the site in advance to arrange an 
auditing visit. The auditor may ask to visit the facilities where laboratory samples are collected, 
where the medication is stored and prepared, and any other facility used during the study. In 
addition, there is the possibility that this study may be inspected by regulatory agencies (such as 
FDA), including those of foreign governments (eg, the FDA, the United Kingdom Medicines and 
Healthcare Products Regulatory Agency - MHRA, the Pharmaceuticals and Medical Devices 
Agency of Japan - PMDA). If the study site is contacted for an inspection by a regulatory body, 
the Sponsor should be notified immediately. The Investigator guarantees access for quality 
assurance auditors to all study documents as described in Section 12.1. 
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13.0 
ETHICAL ASPECTS OF THE STUDY 
This study will be conducted with the highest respect for the individual participants according to 
the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the 
International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for GCP 
[14]. Each Investigator will conduct the study according to applicable local or regional 
regulatory requirements and align his or her conduct in accordance with the “Responsibilities of 
the Investigator” that are listed in Appendix A. The principles of Helsinki are addressed through 
the protocol and through appendices containing requirements for informed consent and 
Investigator responsibilities. 
13.1 
IRB Approval 
IRBs must be constituted according to the applicable state and federal/local requirements of each 
participating region. The Sponsor or designee will require documentation noting all names and 
titles of members who make up the respective IRB. If any member of the IRB has direct 
participation in this study, written notification regarding his or her abstinence from voting must 
also be obtained. Those Americas sites unwilling to provide names and titles of all members due 
to privacy and conflict of interest concerns should instead provide a Federal Wide Assurance 
Number or comparable number assigned by the Department of Health and Human Services. 
The Sponsor or designee will supply relevant documents for submission to the respective IRB for 
the protocol’s review and approval. This protocol, the IB, a copy of the ICF, a copy of the 
palatability questionnaire, and, if applicable, participant recruitment materials and/or 
advertisements and other documents required by all applicable laws and regulations, must be 
submitted to a central or local IRB for approval. The IRB’s written approval of the protocol and 
participant informed consent must be obtained and submitted to the Sponsor or designee before 
commencement of the study (ie, before shipment of the Sponsor-supplied drug or study specific 
screening activity). The IRB approval must refer to the study by exact protocol title, number, and 
version date; identify versions of other documents (eg, ICF) reviewed; and state the approval 
date. The Sponsor will ship drug/notify site once the Sponsor has confirmed the adequacy of site 
regulatory documentation and, when applicable, the Sponsor has received permission from 
competent authority to begin the study. Until the site receives drug/notification no protocol 
activities, including screening, may occur. 
Sites must adhere to all requirements stipulated by their respective IRB. This may include 
notification to the IRB regarding protocol amendments, updates to the ICF, recruitment materials 
intended for viewing by participants, local safety reporting requirements, reports and updates 
regarding the ongoing review of the study at intervals specified by the respective IRB, and 
submission of the Investigator’s final status report to IRB. All IRB approvals and relevant 
documentation for these items must be provided to the Sponsor or its designee. 
Participant incentives should not exert undue influence for participation. Payments to 
participants must be approved by the IRB and Sponsor. 
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13.2 
Participant Information, Informed Consent, and Participant Authorization 
Written consent documents will embody the elements of informed consent as described in the 
Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all 
applicable laws and regulations. The ICF, participant authorization form (if applicable), and 
participant information sheet (if applicable) describe the planned and permitted uses, transfers, 
and disclosures of the participant’s personal and personal health information for purposes of 
conducting the study. The ICF and the participant information sheet (if applicable) further 
explain the nature of the study, its objectives, and potential risks and benefits, as well as the date 
informed consent is given. The ICF will detail the requirements of the participant and the fact 
that he or she is free to withdraw at any time without giving a reason and without prejudice to his 
or her further medical care. 
The Investigator is responsible for the preparation, content, and IRB approval of the ICF and, if 
applicable, the participant authorization form. The ICF, participant authorization form (if 
applicable), and participant information sheet (if applicable) must be approved by both the IRB 
and the Sponsor prior to use. 
The ICF, participant authorization form (if applicable), and participant information sheet (if 
applicable) must be written in a language fully comprehensible to the prospective participant. It 
is the responsibility of the Investigator to explain the detailed elements of the ICF, participant 
authorization form (if applicable), and participant information sheet (if applicable) to the 
participant. Information should be given in both oral and written form whenever possible and in 
the manner deemed appropriate by the IRB. In the event the participant is not capable of 
rendering adequate written informed consent, then the participant’s legally acceptable 
representative may provide such consent for the participant in accordance with applicable laws 
and regulations. 
The participant, or the participant’s legally acceptable representative, must be given ample 
opportunity to: (1) inquire about details of the study, and (2) decide whether or not to participate 
in the study. If the participant, or the participant’s legally acceptable representative, determines 
he or she will participate in the study, then the ICF and participant authorization form (if 
applicable) must be signed and dated by the participant, or the participant’s legally acceptable 
representative, at the time of consent and prior to the participant entering into the study. The 
participant or the participant’s legally acceptable representative should be instructed to sign 
using their legal names, not nicknames, using blue or black ballpoint ink. The Investigator must 
also sign and date the ICF and participant authorization (if applicable) at the time of consent and 
prior to participant entering into the study; however, the Sponsor may allow a designee of the 
Investigator to sign to the extent permitted by applicable law. 
Once signed, the original ICF, participant authorization form (if applicable), and participant 
information sheet (if applicable) will be stored in the Investigator’s site file. The Investigator 
must document the date the participant signs the informed consent in the participant’s medical 
record. Copies of the signed ICF, the signed participant authorization form (if applicable), and 
participant information sheet (if applicable) shall be given to the participant. 
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All revised ICFs must be reviewed and signed by relevant participants or the relevant 
participant’s legally acceptable representative in the same manner as the original informed 
consent. The date the revised consent was obtained should be recorded in the participant’s 
medical record, and the participant should receive a copy of the revised ICF. 
13.3 
Participant Confidentiality 
The Sponsor and designees affirm and uphold the principle of the participant’s right to protection 
against invasion of privacy. Throughout this study, a participant’s source data will only be linked 
to the Sponsor’s clinical study database or documentation via a unique identification number. As 
permitted by all applicable laws and regulations, limited participant attributes, such as sex, age, 
or date of birth, and participant initials may be used to verify the participant and accuracy of the 
participant’s unique identification number. 
To comply with ICH Guidelines for GCP and to verify compliance with this protocol, the 
Sponsor requires the Investigator to permit its monitor or designee’s monitor, representatives 
from any regulatory authority (eg, FDA, MHRA, PMDA), the Sponsor’s designated auditors, 
and the appropriate IRBs to review the participant’s original medical records (source data or 
documents), including, but not limited to, laboratory test result reports, ECG reports, admission 
and discharge summaries for hospital admissions occurring during a participant’s study 
participation, and autopsy reports. Access to a participant’s original medical records requires the 
specific authorization of the participant as part of the informed consent process (see 
Section 13.2). 
Copies of any participant source documents that are provided to the Sponsor must have certain 
personally identifiable information removed (ie, participant name, address, and other identifier 
fields not collected on the participant’s CRF). 
13.4 
Publication, Disclosure, and Clinical Study Registration Policy 
13.4.1 
Publication and Disclosure 
The Investigator is obliged to provide the Sponsor with complete test results and all data derived 
by the Investigator from the study. During and after the study, only the Sponsor may make study 
information available to other study Investigators or to regulatory agencies, except as required by 
law or regulation. Except as otherwise allowable in the clinical study site agreement, any public 
disclosure (including publicly accessible websites) related to the protocol or study results, other 
than study recruitment materials and/or advertisements, is the sole responsibility of the Sponsor. 
The Sponsor may publish any data and information from the study (including data and 
information generated by the Investigator) without the consent of the Investigator. Manuscript 
authorship for any peer-reviewed publication will appropriately reflect contributions to the 
production and review of the document. All publications and presentations must be prepared in 
accordance with this section and the Clinical Study Site Agreement. In the event of any 
discrepancy between the protocol and the Clinical Study Site Agreement, the Clinical Study Site 
Agreement will prevail. 
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13.4.2 
Clinical Study Registration  
In order to ensure that information on clinical trials reaches the public in a timely manner and to 
comply with applicable laws, regulations and guidance, Takeda will, at a minimum register all 
interventional clinical trials it Sponsors anywhere in the world on ClinicalTrials.gov and/or other 
publicly accessible websites before start of study, as defined in Takeda Policy/Standard. Takeda 
contact information, along with Investigator’s city, state (for Americas / United States 
Investigators), country, and recruiting status will be registered and available for public viewing.  
For some registries, Takeda will assist callers in locating study sites closest to their homes by 
providing the Investigator name, address, and phone number to the callers requesting trial 
information. Once participants receive Investigator contact information, they may call the site 
requesting enrollment into the trial. The investigative sites are encouraged to handle the trial 
inquiries according to their established participant screening process. If the caller asks additional 
questions beyond the topic of trial enrollment, they should be referred to the Sponsor. 
Any Investigator who objects to the Sponsor providing this information to callers must provide 
the Sponsor with a written notice requesting that their information not be listed on the registry 
site. 
13.4.3 
Clinical Study Results Disclosure  
Takeda will post the results of clinical studies on ClinicalTrials.gov or other publicly accessible 
websites, as required by Takeda Policy/Standard, applicable laws and/or regulations. 
13.5 
Insurance and Compensation for Injury 
Each participant in the study must be insured in accordance with the regulations applicable to the 
site where the participant is participating. If a local underwriter is required, then the Sponsor or 
Sponsor’s designee will obtain clinical study insurance against the risk of injury to study 
participants. Refer to the study site agreement regarding the Sponsor’s policy on participant 
compensation and treatment for injury. If the Investigator has questions regarding this policy, he 
or she should contact the Sponsor or Sponsor’s designee. 
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14.0 
ADMINISTRATIVE AND REFERENCE INFORMATION 
14.1 
Administrative Information 
14.1.1 
Study Contact Information  
Contact Type / Role 
Contact 
Serious adverse event and pregnancy reporting 
Pharmacovigilance 
Takeda Development Center Americas, Inc. 
Fax:  +1 484-595-8155 
Email: GPSE@Takeda.com 
 
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14.1.2 
INVESTIGATOR AGREEMENT  
I confirm that I have read and that I understand this protocol, the IB, package insert and any 
other product information provided by the Sponsor. I agree to conduct this study in accordance 
with the requirements of this protocol and also to protect the rights, safety, privacy, and 
well-being of study participants in accordance with the following: 
• The ethical principles that have their origin in the Declaration of Helsinki. 
• International Council on Harmonisation, E6[R2] Good Clinical Practice: Consolidated 
Guideline [14]. 
• All applicable laws and regulations, including, without limitation, data privacy laws and 
regulations. 
• Regulatory requirements for reporting serious adverse events defined in Section 10.2.9 of this 
protocol. 
• Terms outlined in the study site agreement. 
• Responsibilities of the Investigator (Appendix A). 
I further authorize that my personal information may be processed and transferred in accordance 
with the uses contemplated in Appendix C of this protocol. 
Signature of Investigator 
Date 
Investigator Name (print or type) 
Investigator’s Title 
Location of Facility (City, State/Provence) 
Location of Facility (Country) 
 
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14.1.3 
Study-Related Responsibilities  
The Sponsor will perform all study-related activities with the exception of those identified in the 
Study-Related Responsibilities template. The vendors identified for specific study-related 
activities will perform these activities in full or in partnership with the Sponsor. 
14.1.4 
List of Abbreviations 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
AUC 
Area under the concentration-time curve 
AUC12h 
Area under the concentration-time curve, from time 0 to 12 hours postdose 
AUC∞ 
Area under the concentration-time curve, from time 0 to infinity 
AUCextrap% 
Percent of AUC∞ extrapolated 
AUClast 
Area under the concentration-time curve, from time 0 to the last quantifiable 
concentration. 
BCS 
Biopharmaceutics Classification System 
BID 
Twice daily 
BMI 
Body mass index 
bpm 
Beats per minute 
C12h 
Concentration at 12 hours postdose 
Cτ 
Projected concentration at 12 hours postdose  
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CL/F 
Apparent clearance after oral administration 
cm 
Centimeter 
Cmax 
Maximum observed concentration  
CMV 
Cytomegalovirus 
COVID-19 
Coronavirus disease 2019 
CPAP 
Clinical Pharmacology Analysis Plan 
CRF 
Case report form 
CRU 
Clinical Research Unit 
CSR 
Clinical study report 
CV 
Coefficient of variance 
CYP 
Cytochrome P450 
DDI 
Drug-drug interactions 
DNA 
Deoxyribonucleic acid  
ECG 
Electrocardiogram 
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FSH 
Follicle stimulating hormone 
FT4 
Free thyroxine 
g 
Gram 
GCP 
Good Clinical Practice 
GI 
Gastrointestinal 
GMR 
Geometric mean ratio 
HBsAg 
Hepatitis B surface antigen 
hCG 
Human chorionic gonadotropin 
HCV 
Hepatitis C virus  
HIV 
Human immunodeficiency virus 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
ID 
Investigational drug 
IRB 
Institutional Review Board 
kg 
Kilogram 
L 
Liter 
LFT 
Liver function test 
m2 
Meters squared 
MedDRA® 
Medical Dictionary for Regulatory Activities® 
mg 
Milligram 
mL 
Milliliter 
mmHg 
Millimeter of mercury 
msec 
Millisecond 
NCA 
Non-compartmental analysis 
NDA 
New drug applications 
PCS 
Potentially clinically significant 
PK 
Pharmacokinetic(s) 
PMDA 
Pharmaceuticals and Medical Devices Agency  
PPI 
Proton pump inhibitor 
QD 
once daily 
QTc 
Corrected QT interval 
QTcF 
QT interval corrected for heart rate using Fridericia’s formula 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
SUSAR 
Suspected unexpected serious adverse reaction 
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t½z 
Terminal disposition phase half-life 
TEAE 
Treatment-emergent adverse event 
tlag 
Lag time to first quantifiable concentration in plasma 
tmax 
Time to first occurrence of Cmax 
TSH 
Thyroid-stimulating hormone 
ULN 
Upper limit of normal 
US 
United States 
USA 
United States of America 
Vz/F 
Apparent volume of distribution during the terminal disposition phase after 
oral administration 
WHO 
World Health Organization 
λz 
Terminal disposition phase rate constant 
 
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15.0 
DATA HANDLING AND RECORDKEEPING 
The full details of procedures for data handling will be documented in the Data Management 
Plan. AEs, medical history, and concurrent conditions will be coded using the MedDRA®. Drugs 
will be coded using the WHO Drug Dictionary. 
15.1 
CRFs (Electronic and Paper) 
Celerion standard CRFs will be supplied. CRFs are produced, stored electronically, and are 
available to the designated study team members. Each CRF is reviewed and signed by the 
Investigator. The final signed CRFs are provided to the Sponsor in the format as decided upon 
between Celerion and the Sponsor (eg, electronically, compact disc, flashdrive, Secure File 
Transfer Protocol). This will be documented in the Data Management Plan (if applicable). 
After completion of the entry process, computer logic checks will be run to identify items, such 
as inconsistent dates, missing data, and questionable values. Queries may be issued by Takeda 
personnel (or designees) and will be answered by the site.  
Corrections are recorded in an audit trail that captures the old information, the new information, 
identification of the person making the correction, the date the correction was made, and the 
reason for change. Reasons for significant corrections should additionally be included.  
The Investigator must review the CRFs for completeness and accuracy and must sign and date 
the appropriate CRFs as indicated. Furthermore, the Investigator must retain full responsibility 
for the accuracy and authenticity of all data entered on the CRFs. 
After the lock of the clinical study database, any change of, modification of, or addition to the 
data on the CRFs should be made by the Investigator with use of change and modification 
records of the CRFs. The Investigator must review the data change for completeness and 
accuracy, and must sign and date. 
CRFs will be reviewed for completeness and acceptability at the study site during periodic visits 
by study monitors. The Sponsor or its designee will be permitted to review the participant’s 
medical and hospital records pertinent to the study to ensure accuracy of the CRFs. The 
completed CRFs are the sole property of the Sponsor and should not be made available in any 
form to third parties, except for authorized representatives of appropriate governmental health or 
regulatory authorities, without written permission of the Sponsor. 
15.2 
Record Retention 
The Investigator agrees to keep the records stipulated in Section 15.1 and those documents that 
include (but are not limited to) the study-specific documents, the identification log of all 
participating participants, medical records, temporary media such as thermal sensitive paper, 
source worksheets, all original signed and dated ICFs, participant authorization forms regarding 
the use of personal health information (if separate from the ICFs), electronic copy of CRFs, 
including the audit trail, and detailed records of drug disposition to enable evaluations or audits 
from regulatory authorities, the Sponsor or its designees. Any source documentation printed on 
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degradable thermal sensitive paper should be photocopied by the site and filed with the original 
in the participant’s chart to ensure long-term legibility. Furthermore, ICH E6 Section 4.9.5 
requires the Investigator to retain essential documents specified in ICH E6 (Section 8) until at 
least 2 years after the last approval of a marketing application for a specified drug indication 
being investigated or, if an application is not approved, until at least 2 years after the 
investigation is discontinued and regulatory authorities are notified. In addition, ICH E6 
Section 4.9.5 states that the study records should be retained until an amount of time specified by 
applicable regulatory requirements or for a time specified in the Clinical Study Site Agreement 
between the Investigator and Sponsor. 
Refer to the Clinical Study Site Agreement for the Sponsor’s requirements on record retention. 
The Investigator and the head of the institution should contact and receive written approval from 
the Sponsor before disposing of any such documents. 
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16.0 
REFERENCES 
1. LIVTENCITYTM (maribavir milled tablets): US Prescribing Information. 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215596lbl.pdf. 
2. Avery RK, Alain S, Alexander BD, Blumberg EA, Chemaly RF, et al. Maribavir for 
refractory cytomegalovirus infections with or without resistance post-transplant: results from 
a phase 3 randomized clinical trial. Clin Infect Dis. 2022 Sept 10;75(4):690-701. 
doi:10.1093/cid/ciab988. 
3. Biron KK, Harvey RJ, Chamberlain SC, Good SS, Smith A, et al. 2002. Potent and selective 
inhibition of human cytomegalovirus replication by 1263W94, a benzimidazole L-riboside 
with a unique mode of action. Antimicrob Agents Chemother; 2002 Aug;46(8):2365-72. doi: 
10.1128/AAC.46.8.2365-2372.2002. 
4. SHP620 (Maribavir). Investigator’s Brochure Edition 22.0 (24 Jan 2023). 
5. LIVTENCITY EPAR SmPC. Summary of Product characteristics.  
https://www.ema.europa.eu/en/documents/product-information/livtencity-epar-product-
information_en.pdf. 
6. Genentech, Inc. Valcyte (valganciclovir hydrochloride) [package insert]. U.S. Food and Drug 
Administration website. 
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dc548ff9-e8ea-4d6e-b9b4-
e31f53ac4078 Revised June 2017. Accessed January 10, 2023.  
7. Ishizaki T, Horai Y. Review article: cytochrome P450 and the metabolism of proton pump 
inhibitors--emphasis on rabeprazole. Aliment Pharmacol Ther. 1999 Aug;13 Suppl 3:27-36. 
doi: 10.1046/j.1365-2036.1999.00022. 
8. Vo L, Simonian HP, Doma S, Fisher RS, Parkman HP. The effect of rabeprazole on regional 
gastric acidity and the postprandial cardia/gastro-oesophageal junction acid layer in normal 
subjects: a randomized, double-blind, placebo-controlled study. Aliment Pharmacol Ther; 
2005 Jun 1;21(11):1321-30. doi: 10.1111/j.1365-2036.2005.02489.x. 
9. Dash RP, Rais R, Srinivas NR. Stereoselective and non-stereoselective pharmacokinetics of 
rabeprazole – an overview. Xenobiotica; 2018 Apr;48(4):422-432. 
10. Miner JR P, Katz PO, Chen Y, Sostek M. Gastric acid control with esomeprazole, 
lansoprazole, omeprazole, pantoprazole, and rabeprazole: a five-way crossover study. Am J 
Gastroenterol; 2003 Dec;98(12):2616-20. doi: 10.1111/j.1572-0241.2003.08783. 
11. ACIPHEX® (rabeprazole sodium) Delayed-Release Tablets, for oral use, prescribing 
information published on FDA website (document revised: 12/2014). Available at: 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf. 
12. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance 
for Industry: Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing 
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Agents: Study Design, Data Analysis, and Clinical Implications. March 2023. Available at: 
https://www.fda.gov/media/166156/download. 
13. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance 
for Industry: Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical 
Pharmacology Considerations. June 2022. Available at: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/assessing-effects-food-drugs-inds-and-ndas-
clinical-pharmacology-considerationsand. 
14. ICH harmonized guideline Integrated addendum to ICH 6[R1]: Guideline for Good Clinical 
Practice E6[R2], Step 4 version, November 2016. Available at: 
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. 
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17.0 
APPENDICES 
Appendix A Responsibilities of the Investigator 
Clinical research studies sponsored by the Sponsor are subject to ICH GCP and all the applicable 
local laws and regulations. The responsibilities imposed on Investigators by the FDA are 
summarized in the “Statement of Investigator” (Form FDA 1572), which must be completed and 
signed before the Investigator may participate in this study. 
The Investigator agrees to assume the following responsibilities by signing a Form FDA 1572: 
1. Conduct the study in accordance with the protocol. 
1. Personally conduct or supervise the staff that will assist in the protocol. 
2. If the Investigator/institution retains the services of any individual or party to perform trial-
related duties and functions, the Investigator/institution should ensure that this individual or 
party is qualified to perform those trial-related duties and functions and should implement 
procedures to ensure the integrity of the trial-related duties and functions performed and any 
data generated. 
3. Ensure that study related procedures, including study specific (nonroutine/nonstandard panel) 
screening assessments are NOT performed on potential participants, prior to the receipt of 
written approval from relevant governing bodies/authorities. 
4. Ensure that all colleagues and employees assisting in the conduct of the study are informed 
of these obligations. 
5. Secure prior approval of the study and any changes by an appropriate IRB that conform to 
21 CFR Part 56, ICH, and local regulatory requirements. 
6. Ensure that the IRB will be responsible for initial review, continuing review, and approval of 
the protocol. Promptly report to the IRB all changes in research activity and all anticipated 
risks to participants. Make at least yearly reports on the progress of the study to the IRB, and 
issue a final report within 3 months of study completion. 
7. Ensure that requirements for informed consent, as outlined in 21 CFR Part 50, ICH and local 
regulations, are met. 
8. Obtain valid informed consent from each participant who participates in the study, and 
document the date of consent in the participant’s medical chart. Valid informed consent is the 
most current version approved by the IRB. Each ICF should contain a participant 
authorization section that describes the uses and disclosures of a participant’s personal 
information (including personal health information) that will take place in connection with 
the study. If an ICF does not include such a participant authorization, then the Investigator 
must obtain a separate participant authorization form from each participant or the 
participant’s legally acceptable representative. 
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9. Prepare and maintain adequate case histories of all persons entered into the study, including 
CRFs, hospital records, laboratory results, etc, and maintain these data for a minimum of 
2 years following notification by the Sponsor that all investigations have been discontinued 
or that the regulatory authority has approved the marketing application. The Investigator 
should contact and receive written approval from the Sponsor before disposing of any such 
documents. 
10. Allow possible inspection and copying by the regulatory authority of GCP-specified essential 
documents. 
11. Maintain current records of the receipt, administration, and disposition of Sponsor-supplied 
drugs, and return all unused Sponsor-supplied drugs to the Sponsor.  
12. Report adverse reactions to the Sponsor promptly. In the event of an SAE, notify the Sponsor 
within 24 hours. 
 
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Appendix B Elements of the Participant Informed Consent 
In seeking informed consent, the following information shall be provided to each participant: 
1. A statement that the study involves research. 
2. An explanation of the purposes of the research. 
3. The expected duration of the participant’s participation. 
4. A description of the procedures to be followed, including invasive procedures. 
5. The identification of any procedures that are experimental. 
6. The estimated number of participants involved in the study. 
7. A description of the participant’s responsibilities. 
8. A description of the conduct of the study. 
9. A statement describing the treatment(s) and the probability for random assignment to each 
treatment. 
10. A description of the possible side effects of the treatment that the participant may receive. 
11. A description of any reasonably foreseeable risks or discomforts to the participant and, when 
applicable, to an embryo, fetus, or nursing infant. 
12. A description of any benefits to the participant or to others that reasonably may be expected 
from the research. When there is no intended clinical benefit to the participant, the participant 
should be made aware of this. 
13. Disclosures of appropriate alternative procedures or courses of treatment, if any, that might 
be advantageous to the participant and their important potential risks and benefits. 
14. A statement describing the extent to which confidentiality of records identifying the 
participant will be maintained, and a note of the possibility that regulatory agencies, 
auditor(s), IRB, and the monitor may inspect the records. By signing a written ICF, the 
participant or the participant’s legally acceptable representative is authorizing such access. 
15. For research involving more than minimal risk, an explanation as to whether any 
compensation and an explanation as to whether any medical treatments are available if injury 
occurs and, if so, what they consist of or where further information may be obtained. 
16. The anticipated prorated payment(s), if any, to the participant for participating in the study. 
17. The anticipated expenses, if any, to the participant for participating in the study. 
18. An explanation of whom to contact for answers to pertinent questions about the research 
(Investigator), participant’s rights, and IRB and whom to contact in the event of a 
research-related injury to the participant. 
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19. A statement that participation is voluntary, that refusal to participate will involve no penalty 
or loss of benefits to which the participant otherwise is entitled, and that the participant or the 
participant’s legally acceptable representative may discontinue participation at any time 
without penalty or loss of benefits to which the participant is otherwise entitled. 
20. The consequences of a participant’s decision to withdraw from the research and procedures 
for orderly termination of participation by the participant. 
21. A statement that the participant or the participant’s legally acceptable representative will be 
informed in a timely manner if information becomes available that may be relevant to the 
participant’s willingness to continue participation in the study. 
22. The foreseeable circumstances or reasons under which the participant’s participation in the 
study may be terminated. 
23. A written participant authorization (either contained within the ICF or provided as a separate 
document) describing to the participant the contemplated and permissible uses and 
disclosures of the participant’s personal information (including personal health information) 
for purposes of conducting the study. The participant authorization must contain the 
following statements regarding the uses and disclosures of the participant’s personal 
information: 
a) that personal information (including personal health information) may be processed by or 
transferred to other parties in other countries for clinical research and safety reporting 
purposes, including, without limitation, to the following: (1) Takeda, its affiliates, and 
licensing partners; (2) business partners assisting Takeda, its affiliates, and licensing 
partners; (3) regulatory agencies and other health authorities; and (4) IRBs; 
b) it is possible that personal information (including personal health information) may be 
processed and transferred to countries that do not have data protection laws that offer 
participants the same level of protection as the data protection laws within this country; 
however, Takeda will make every effort to keep your personal information confidential, 
and your name will not be disclosed outside the clinic unless required by law; 
c) that personal information (including personal health information) may be added to 
Takeda’s research databases for purposes of developing a better understanding of the 
safety and effectiveness of the ID(s), studying other therapies for patients, developing a 
better understanding of disease, and improving the efficiency of future clinical studies; 
d) that participants agree not to restrict the use and disclosure of their personal information 
(including personal health information) upon withdrawal from the study to the extent that 
the restricted use or disclosure of such information may impact the scientific integrity of 
the research; and 
e) that the participant’s identity will remain confidential in the event that study results are 
published. 
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24. Female participants of childbearing potential (eg, nonsterilized, premenopausal female 
participants) who are sexually active must use highly effective contraception (as defined in 
the informed consent) from signing the informed consent and throughout the duration of the 
study, and for 1 month after the last dose. If a participant is found to be pregnant during 
study, dosing will be discontinued.  
25. Male participants must use an effective contraception (as defined in the informed consent) 
from signing the informed consent throughout the duration of the study and for 3 months 
after the last dose. 
26. A statement that clinical trial information from this trial will be publicly disclosed in a 
publicly accessible website, such as ClinicalTrials.gov. 
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Appendix C Investigator Consent to the Use of Personal Information  
Takeda will collect and retain personal information of Investigator, including his or her name, 
address, and other personally identifiable information. In addition, Investigator’s personal 
information may be transferred to other parties located in countries throughout the world (eg, the 
United Kingdom, United States, and Japan), including the following: 
• Takeda, its affiliates, and licensing partners. 
• Business partners assisting Takeda, its affiliates, and licensing partners. 
• Regulatory agencies and other health authorities. 
• IRBs. 
Investigator’s personal information may be retained, processed, and transferred by Takeda and 
these other parties for research purposes including the following: 
• Assessment of the suitability of Investigator for the study and/or other clinical studies. 
• Management, monitoring, inspection, and audit of the study. 
• Analysis, review, and verification of the study results. 
• Safety reporting and pharmacovigilance relating to the study. 
• Preparation and submission of regulatory filings, correspondence, and communications to 
regulatory agencies relating to the study. 
• Preparation and submission of regulatory filings, correspondence, and communications to 
regulatory agencies relating to other medications used in other clinical studies that may 
contain the same chemical compound present in the study drug. 
• Inspections and investigations by regulatory authorities relating to the study. 
• Self-inspection and internal audit within Takeda, its affiliates, and licensing partners. 
• Archiving and audit of study records. 
• Posting Investigator site contact information, study details and results on publicly accessible 
clinical trial registries, databases, and websites. 
Investigator’s personal information may be transferred to other countries that do not have data 
protection laws that offer the same level of protection as data protection laws in Investigator’s 
own country. 
Investigator acknowledges and consents to the use of his or her personal information by Takeda 
and other parties for the purposes described above. 
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Appendix D Pregnancy and Contraception 
Contraception and Pregnancy Avoidance Procedure 
Male Participants 
From signing of informed consent, throughout the duration of the study, and for 3 months after 
last dose of study drug, nonsterilized** male participants who are sexually active with a female 
partner of childbearing potential* must use barrier contraception (eg, condom with or without 
spermicidal cream or jelly). In addition, they must be advised not to donate sperm during this 
period. 
Female Participants and Their Males Partners 
From signing of informed consent, throughout the duration of the study, and for 1 month after 
last dose of study drug, female participants of childbearing potential* who are sexually active 
with a nonsterilized male partner** must use a highly effective/effective method of contraception 
(from the list below). In addition they must be advised not to donate ova during this period. 
Definitions and Procedures for Contraception and Pregnancy Avoidance 
The following definitions apply for contraception and pregnancy avoidance procedures. 
* A woman is considered a woman of childbearing potential, ie fertile, following menarche and 
until becoming post-menopausal unless permanently sterile. Permanent sterilization methods 
include hysterectomy, and bilateral oophorectomy. A postmenopausal state is defined as no 
menses for 12 months without an alternative medical cause. A high FSH level in the 
postmenopausal range (FSH >40 IU/L) may be used to confirm a post-menopausal state in 
younger women (eg, those <45 year old) or women who are not using hormonal contraception or 
hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single 
FSH measurement is insufficient. 
** Sterilized males should be at least 1 year post-bilateral vasectomy and have confirmed that 
they have obtained documentation of the absence of sperm in the ejaculate or have had bilateral 
orchidectomy. 
The following procedures apply for contraception and pregnancy avoidance. 
1. Highly effective methods of contraception are defined as “those, alone or in combination, 
that result in a low failure rate (ie, less than 1% failure rate per year when used consistently 
and correctly). In this study, where medications and devices containing hormones are 
included, the only acceptable methods of contraception are:  
Non-Hormonal Methods:  
– Intrauterine device. 
– Bilateral tubal occlusion. 
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– Vasectomy, provided that partner is the sole sexual partner of the study participant 
and that the vasectomised partner has received medical assessment of the surgical 
success. 
– True sexual abstinence, only if this is in line with the preferred and usual lifestyle of 
the participant. True abstinence is defined as refraining from heterosexual intercourse 
during the entire period of the study, from 1 month prior to the first dose of study 
drug until 1 month after last dose of study drug for female participants of childbearing 
potential* and 3 months after the last dose of study drug for male participants. 
Hormonal Methods: 
– Combined (estrogen and progestogen) hormonal contraception associated with 
inhibition of ovulation initiated at least 3 months prior to the first dose of study drug 
OR combined with a barrier method (male condom, female condom or diaphragm) if 
for shorter duration until she has been on contraceptive for 3 months; 
Oral 
Intravaginal (eg, ring) 
Transdermal 
– Progestogen-only hormonal contraception associated with inhibition of ovulation1 
initiated at least 3 months prior to the first dose of study drug OR combined with a 
barrier method (male condom, female condom or diaphragm) if shorter till she has 
been on contraceptive for 3 months; 
Oral 
Injectable 
Implantable 
Intrauterine device 
2. In addition, effective methods of contraception (there may be a higher than 1% failure rate) 
are:  
- 
Female participant: Double-barrier method (contraceptive sponge, diaphragm or cervical 
cap with spermicidal jellies or creams PLUS male condom). 
- 
Female participant: Progestogen only hormonal contraception, where inhibition of 
ovulation is not the primary mode of action PLUS condom with or without spermicide. 
- 
Male participant with female partner of childbearing potential: A barrier method 
(condom with or without spermicidal cream or jelly). 
3. Unacceptable methods of contraception are: 
- 
Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods). 
- 
Spermicides only. 
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- 
Withdrawal. 
- 
No method at all. 
- 
Use of female and male condoms together. 
- 
Cap/diaphragm/sponge without spermicide and without condom. 
- 
Sexual abstinence is NOT an acceptable method of contraception, unless it is true sexual 
abstinence. 
4. Participants will be provided with information on highly effective/effective methods of 
contraception as part of the participant informed consent process and will be asked to sign a 
consent form stating that they understand the requirements for avoidance of pregnancy, 
donation of ova, and sperm donation during the course of the study. 
5. During the course of the study, regular serum human chorionic gonadotropin (hCG) 
pregnancy tests will be performed only for women of childbearing potential and all 
participants (male and female) will receive continued guidance with respect to the avoidance 
of pregnancy and sperm donation as part of the study procedures. Such guidance should 
include a reminder of the following: 
f) contraceptive requirements of the study 
g) reasons for use of barrier methods (ie, condom) in males with pregnant partners 
h) assessment of participant compliance through questions such as 
i. Have you used the contraception consistently and correctly since the last visit? 
ii. Have you forgotten to use contraception since the last visit?  
iii. Are your menses late (even in women with irregular or infrequent menstrual cycles a 
pregnancy test must be performed if the answer is “yes”) 
iv. Is there a chance you could be pregnant? 
6. In addition to a negative serum hCG pregnancy test at the screening visit, female participants 
of childbearing potential must also have confirmed menses in the month before first dose of 
study drug (no delayed menses; with the exception of female participants using a protocol 
acceptable contraception method that has a known side effect of delayed or irregular 
menses), and, a negative serum hCG pregnancy test prior to receiving any dose of study 
drugs. In addition, participants must also have a negative serum hCG pregnancy test within 
28 days prior to receiving first dose of study drug. 
General Guidance With Respect to the Avoidance of Pregnancy 
Such guidance should include a reminder of the following: 
• contraceptive requirements of the study. 
• reasons for use of barrier methods (ie, condom) in males with pregnant partners. 
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• assessment of participant compliance through questions such as: 
– Have you used the contraception consistently and correctly since the last visit? 
– Have you forgotten to use contraception since the last visit? 
– Are your menses late (even in women with irregular or infrequent menstrual 
cycles a pregnancy test must be performed if the answer is “yes”) 
– Is there a chance you could be pregnant? 
Pregnancy 
If a female participant is found to be pregnant during the study she should be withdrawn and any 
sponsor-supplied drug should be immediately discontinued. In addition, any pregnancies in the 
partner of a male participant during the study or for 3 months after the last dose, should also be 
recorded following authorization from the participant’s partner.  
If the female participant and/or female partner of a male participant agrees to the primary care 
physician being informed, the Investigator should notify the primary care physician of her or her 
male partner (ie, male participant) participation in a clinical study at the time she became 
pregnant and provide details of study drug the female participant or her male partner (ie, male 
participant) received. 
All pregnancies, including female partners of male participants, in participants on active study 
drug (including comparator, if applicable) will be followed up to final outcome, using the 
pregnancy form. Pregnancies will remain blinded to the study team. The outcome, including any 
premature termination, must be reported to the Sponsor. An evaluation after the birth of the child 
will also be conducted. 
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