Clinical trial NCT03660839
Conditions: Plasmodium Falciparum Infection
Sponsor: Sanofi
Start date: 2018-09-11; Completion date: 2019-11-06
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) for the effect and the area under the curve (AUC) of OZ439 as pharmacokinetic (PK) predictor.

Secondary Objectives:

* To evaluate the exposure-response of OZ439 combined with FQ on crude Day 28 ACPR.
* To evaluate the dose response of OZ439 combined with FQ on PCR-corrected and crude Day 28 ACPR.
* To evaluate the dose-response of OZ439 combined with FQ on selected secondary endpoints.
* To evaluate the safety and tolerability of different dosages of OZ439 in combination with FQ and FQ alone.
* To characterize the PK of OZ439 in plasma, and of FQ and its active metabolite SSR97213 in blood.

Detailed description:
The duration of the study was up to 32 days, including up to 1 day screening period before the single-dose treatment, 5 days of post-treatment surveillance (included 2 to 4 days hospitalization) and 24±2 days follow-up period.

Arms: arm 1: On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition. arm 2: On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension. arm 3: On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension. arm 4: On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension.
Interventions: intervention 1: Artefenomel (OZ439) intervention 2: Ferroquine (SSR97193)
Intervention descriptions: intervention 1: Pharmaceutical form: Granules for oral suspension Route of administration: Oral intervention 2: Pharmaceutical form: Capsule Route of administration: Oral

Protocol documents:
Prot_000.pdf: 
Any and all information presented in this document shall be treated as confidential and shall remain the exclusive property of Sanofi (or any of its 
affiliated companies). The use of such confidential information must be restricted to the recipient for the agreed purpose and must not be 
disclosed, published or otherwise communicated to any unauthorized persons, for any reason, in any form whatsoever without the prior written 
consent of Sanofi (or the concerned affiliated company); ‘affiliated company’ means any corporation, partnership or other entity which at the date 
of communication or afterwards (i) controls directly or indirectly Sanofi, (ii) is directly or indirectly controlled by Sanofi, with ‘control’ meaning 
direct or indirect ownership of more than 50% of the capital stock or the voting rights in such corporation, partnership or other entity 
According to template: Version Sanofi dated 01-JUN-2017 based on TransCelerate CPT version 3 
Page 1 
CLINICAL TRIAL PROTOCOL  
Protocol title: 
A Randomized, Open label, Parallel-group, Single Dose 
Regimen, Phase 2a Study, to Investigate the Clinical 
and Parasiticidal Activity and the Pharmacokinetics of 3 
dose levels of Artefenomel (OZ439) given in 
combination with Ferroquine (FQ) and FQ alone, in 
African Patients with Uncomplicated Plasmodium 
falciparum Malaria 
Protocol number: 
ACT14655 
Amendment number: 
Not applicable 
Compound number 
(Trademark/INN): 
OZ439 (artefenomel) and SSR97193 (ferroquine)  
Short title: 
A Randomized, Open, Parallel-group, Single Dose, 
Phase 2a Study, to Investigate the Clinical and 
Parasiticidal Activity and the Pharmacokinetics of 3 
dose levels of Artefenomel in combination with 
Ferroquine (FQ) and FQ alone, in African Patients with 
Uncomplicated Plasmodium falciparum Malaria 
Sponsor name and legal 
registered address: 
Regulatory agency identifying numbers: 
IND number: 
FQ: IND115244 
OZ439: IND104549 
UTN number: 
U1111-1191-5573 
Approval Date: 
13-Nov-2017
Total number of pages: 93 
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NCT03660839


Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi Group - strictly confidential 
Page 2 
Sponsor Signatory: 
 
 
 
 
 
 
 
 
 
 
 
Monitoring Team’s Representative 
Name and Contact Information: 
 
 
 
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Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi Group - strictly confidential 
Page 3 
TABLE OF CONTENTS 
CLINICAL TRIAL PROTOCOL.......................................................................................................................1 
TABLE OF CONTENTS..................................................................................................................................3 
LIST OF TABLES ...........................................................................................................................................6 
LIST OF FIGURES..........................................................................................................................................6 
1 
SYNOPSIS.......................................................................................................................................7 
2 
SCHEDULE OF ACTIVITIES (SOA) .............................................................................................11 
3 
INTRODUCTION............................................................................................................................15 
3.1 
STUDY RATIONALE......................................................................................................................15 
3.2 
BACKGROUND .............................................................................................................................16 
3.3 
BENEFIT/RISK ASSESSMENT.....................................................................................................16 
4 
OBJECTIVES AND ENDPOINTS .................................................................................................18 
4.1 
APPROPRIATENESS OF MEASUREMENTS ..............................................................................19 
5 
STUDY DESIGN ............................................................................................................................21 
5.1 
OVERALL DESIGN........................................................................................................................21 
5.2 
PARTICIPANT AND STUDY COMPLETION ................................................................................22 
5.3 
END OF STUDY DEFINITION.......................................................................................................22 
5.4 
SCIENTIFIC RATIONALE FOR STUDY DESIGN.........................................................................23 
5.5 
JUSTIFICATION FOR DOSE ........................................................................................................23 
6 
STUDY POPULATION ..................................................................................................................25 
6.1 
INCLUSION CRITERIA..................................................................................................................25 
6.2 
EXCLUSION CRITERIA ................................................................................................................26 
6.3 
LIFESTYLE RESTRICTIONS ........................................................................................................28 
6.3.1 
Meals and dietary restrictions ........................................................................................................28 
6.4 
SCREEN FAILURES......................................................................................................................28 
7 
TREATMENTS...............................................................................................................................29 
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7.1 
TREATMENTS ADMINISTERED ..................................................................................................29 
7.1.1 
Investigational Medicinal Products.................................................................................................29 
7.1.2 
Noninvestigational Medicinal Products ..........................................................................................30 
7.2 
DOSE MODIFICATION..................................................................................................................30 
7.3 
METHOD OF TREATMENT ASSIGNMENT .................................................................................30 
7.4 
BLINDING ......................................................................................................................................31 
7.5 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY.......................................................31 
7.6 
TREATMENT COMPLIANCE ........................................................................................................32 
7.7 
CONCOMITANT THERAPY ..........................................................................................................32 
7.7.1 
Rescue medicine............................................................................................................................33 
7.8 
TREATMENT AFTER THE END OF THE STUDY........................................................................34 
8 
DISCONTINUATION/WITHDRAWAL CRITERIA.........................................................................35 
8.1 
DISCONTINUATION OF STUDY TREATMENT ...........................................................................35 
8.2 
WITHDRAWAL FROM THE STUDY .............................................................................................35 
8.3 
LOST TO FOLLOW UP .................................................................................................................35 
9 
STUDY ASSESSMENTS AND PROCEDURES ...........................................................................37 
9.1 
EFFICACY ASSESSMENTS .........................................................................................................37 
9.1.1 
MEASUREMENT OF PARASITEMIA............................................................................................37 
9.2 
ADVERSE EVENTS.......................................................................................................................39 
9.2.1 
Time period and frequency for collecting AE and SAE information...............................................41 
9.2.2 
Method of detecting AEs and SAEs...............................................................................................41 
9.2.3 
Follow-up of AEs and SAEs...........................................................................................................41 
9.2.4 
Regulatory reporting requirements for SAEs .................................................................................41 
9.2.5 
Cardiovascular and death events ..................................................................................................42 
9.2.6 
Disease-related events and/or disease-related outcomes not qualifying as AEs or SAEs ...........42 
9.2.7 
Pregnancy......................................................................................................................................42 
9.2.8 
Guidelines for reporting product complaints ..................................................................................42 
9.3 
TREATMENT OF OVERDOSE......................................................................................................42 
9.4 
SAFETY ASSESSMENTS .............................................................................................................43 
9.4.1 
Physical examinations ...................................................................................................................43 
9.4.2 
Vital signs.......................................................................................................................................43 
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9.4.3 
Electrocardiograms ........................................................................................................................44 
9.4.4 
Clinical safety laboratory assessments..........................................................................................44 
9.5 
PHARMACOKINETICS..................................................................................................................44 
9.6 
PHARMACODYNAMICS ...............................................................................................................47 
9.7 
GENETICS.....................................................................................................................................47 
9.8 
BIOMARKERS ...............................................................................................................................47 
9.9 
MEDICAL RESOURCE UTILIZATION AND HEALTH ECONOMICS ...........................................47 
10 
STATISTICAL CONSIDERATIONS..............................................................................................48 
10.1 
SAMPLE SIZE DETERMINATION.................................................................................................48 
10.2 
POPULATIONS FOR ANALYSES.................................................................................................48 
10.3 
STATISTICAL ANALYSES ............................................................................................................49 
10.3.1 
Efficacy analyses ...........................................................................................................................49 
10.3.2 
Safety analyses..............................................................................................................................51 
10.3.3 
PK analyses ...................................................................................................................................53 
10.3.4 
Other analyses...............................................................................................................................53 
10.3.5 
Interim analyses.............................................................................................................................54 
11 
REFERENCES...............................................................................................................................55 
12 
APPENDICES................................................................................................................................57 
APPENDIX 1 ABBREVIATIONS ................................................................................................................58 
APPENDIX 2 CLINICAL LABORATORY TESTS.......................................................................................60 
APPENDIX 3 STUDY GOVERNANCE CONSIDERATIONS.....................................................................61 
APPENDIX 4 ADVERSE EVENTS: DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW-UP, AND REPORTING.........................................................................65 
APPENDIX 5 CONTRACEPTIVE GUIDANCE AND COLLECTION OF PREGNANCY 
INFORMATION..............................................................................................................................70 
APPENDIX 6 FORBIDDEN MEDICATION ................................................................................................73 
APPENDIX 7 LIVER AND OTHER SAFETY: SUGGESTED ACTIONS AND FOLLOW-UP 
ASSESSMENTS ............................................................................................................................82 
APPENDIX 8 SAMPLE SIZE DETERMINATION.......................................................................................90 
APPENDIX 9 COUNTRY-SPECIFIC REQUIREMENTS ...........................................................................93 
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LIST OF TABLES 
Table 1 - Objectives and endpoints...............................................................................................................18 
Table 2 - Overview of treatments administered ............................................................................................29 
Table 3 – Numbering of PK samples.............................................................................................................45 
 
Table 5 – Summary of handling procedure of PK plasma samples..............................................................46 
Table 6 – Summary of PK bioanalytical methods .........................................................................................46 
Table 7 - Populations for analyses ................................................................................................................48 
Table 8 - Efficacy analyses ...........................................................................................................................49 
Table 9 - Safety analyses..............................................................................................................................51 
Table 10 - PK analyses .................................................................................................................................53 
Table 11 - Protocol-required safety laboratory assessments........................................................................60 
Table 12 - Highly effective contraceptive methods .......................................................................................71 
 
LIST OF FIGURES 
Figure 1 - Graphical study design .................................................................................................................22 
 
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1 
SYNOPSIS 
Protocol title: A Randomized, Open label, Parallel-group, Single Dose Regimen, Phase 2a 
Study, to Investigate the Clinical and Parasiticidal Activity and the 
Pharmacokinetics of 3 dose levels of Artefenomel (OZ439) given in combination 
with Ferroquine (FQ) and FQ alone, in African Patients with Uncomplicated 
Plasmodium falciparum Malaria 
Short title: 
A Randomized, Open, Parallel-group, Single Dose, Phase 2a Study, to Investigate 
the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 dose levels 
of Artefenomel in combination with Ferroquine (FQ) and FQ alone, in African 
Patients with Uncomplicated Plasmodium falciparum Malaria 
Rationale: 
Plasmodium falciparum (P. falciparum) malaria remains a deadly endemic parasitic disease, with 
212 million new cases and over 429,000 deaths reported in 2015. World Health Organization 
(WHO) guidelines recommend that artemisinin-based combination therapies (ACT) are used to 
treat uncomplicated P. falciparum malaria, which is administrated in a 3-day regimen. Sanofi and 
Medicines for Malaria Venture (MMV) are co-developing a fixed dose combination (FDC) of FQ 
and artefenomel (OZ439) for a single dose treatment of uncomplicated malaria in adults and 
children. Per Food and Drug Administration (FDA) guidance for co-development of 2 new 
investigational drugs for use in combination, it is recommended to demonstrate the contribution of 
each individual component to the effect of the combination. This phase 2a study will test clinical 
and parasiticidal activity, pharmacokinetics (PK) and safety of 3 doses of OZ439 associated with 
a fixed dose of FQ and FQ alone. 
Objectives and endpoints 
Objective 
Endpoint 
Primary 
• 
To show the contribution of OZ439 to the clinical and 
parasiticidal effect of OZ439/FQ combination by 
analyzing exposure-response of OZ439 measured by 
Day 28 polymerase chain reaction (PCR)-corrected 
adequate clinical and parasitological response 
(ACPR) for the effect and the area under the 
concentration time curve up to infinity (AUC) of 
OZ439 as PK predictor 
• 
Day 28 PCR-corrected ACPR 
Secondary 
• 
To evaluate the dose response of OZ439 combined 
with FQ on PCR-corrected and crude Day 28 ACPR 
• 
Day 28 PCR-corrected ACPR 
• 
Day 28 crude ACPR 
• 
To evaluate the dose-response of OZ439 combined 
with FQ on selected secondary endpoints  
• 
Parasitemia at baseline then every 6 h during the first 
36 h then at 48 h and every 24 h until Day 7 
• 
Observed parasite reduction rate (PRR) at 24 h, 
48 h, and 72 h 
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Clinical Trial Protocol 
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• 
Time to 99% parasite reduction  
• 
Time to parasite clearance 
• 
Parasite clearance rate 
• 
Time to recrudescence or re-infection 
• 
time elapsed below limit of quantification (LOQ) of 
parasitemia 
• 
To evaluate the safety and tolerability of different 
dosages of OZ439 in combination with FQ and FQ 
alone 
• 
Adverse events (AEs) including  Serious AEs (SAEs), 
AEs of Special Interest (AESIs) and Treatment 
Emergent AEs (TEAEs)  
• 
Clinical laboratory  tests (including liver function tests 
[LFT]), vital signs, and electrocardiogram (ECG) 
including QTc assessment 
• 
Physical examination and clinical signs and 
symptoms related to uncomplicated P. falciparum 
malaria (fever, dizziness, headache, nausea, 
anorexia, vomiting, diarrhea, itching, urticaria, skin 
rash, abdominal pain, joint pain, muscle pain, 
palpitations, sleep problems, confusion, hearing 
problems, vision problems, and fatigue). 
• 
To characterize the PK of OZ439 in plasma, and of 
FQ and its active metabolite SSR97213 in blood 
• 
Concentrations of OZ439 in plasma, and of FQ and 
SSR97213 in blood at specific time points  
• 
PK parameters for OZ439 in plasma, and for FQ and 
SSR97213 in blood, including: 
- 
maximal concentration (Cmax) 
- 
time to reach Cmax (tmax) 
- 
concentration at 168 h post dose (C168h) 
- 
AUC 
- 
terminal half-life (t1/2) 
- 
area under the concentration time curve from T0 
to Day 28 (AUC0-Day28) for FQ and SSR97213 
only 
Overall design: 
A phase 2a, randomized, open label, parallel-group study, single-dose regimen, testing 3 dose 
levels of OZ439 given in combination with FQ and FQ alone in participants with uncomplicated 
P. falciparum malaria. Adults up to 69 years old and adolescents as of 14 years old will be 
included in 4 parallel arms in a 1:1:1:1 randomization ratio. Randomization will occur the day of 
or up to 1 day after screening procedures. 
Participants will receive one of the 4 treatments: FQ 400 mg alone or combined with 
OZ439 300 mg, 600 mg, or 1000 mg.  
Participants will be hospitalized for the first 48 hours or up to 4 days or longer upon investigator’s 
judgment. 
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Clinical Trial Protocol 
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Number of participants: 
Participants will be screened to achieve 140 randomly assigned to study treatment and 120 
evaluable participants for an estimated total of 30 evaluable participants per treatment group. 
Details on sample size determination are provided in Section 10.1.  
Evaluable participants are defined as all randomized participants with parasitologically confirmed 
malaria at baseline, who received the single administration of investigational medicinal product 
(IMP) and having parasitemia data post-randomization (Section 10.2). 
Treatment groups and duration: 
Study will last for up to 32 days for each participant: 
• 
Up to 1 day screening period before the single-dose treatment 
• 
5 days of post-treatment surveillance, including 2 to 4 days hospitalization 
• 
24±2 days follow-up 
Study treatments 
Study treatments include FQ (all participants including arm A), OZ439 + FQ (participants of 
study arms B, C, and D), and a rescue therapy (all participants). 
IMP: FQ (SSR97193) 
• 
Formulation: 100 mg capsules 
• 
Route of administration: oral 
• 
Dose regimen: single dose of 400 mg given before OZ439 
IMP: Artefenomel (OZ439) 
• 
Formulation: sachet of 300 mg, 400 mg, and 600 mg of OZ439-alpha tocopherol 
polyethylene glycol 1000 succinate (TPGS) formulation + sachet of sucrose 
• 
Route of administration: oral 
• 
Dose regimen: single dose given after FQ, depending on the treatment arm: 0 mg for 
arm A, 300 mg for arm B, 600 mg for arm C, and 1000 mg for arm D 
Noninvestigational medicinal products: rescue therapy 
• 
A rescue treatment will be systematically administered at Day 28 for participants who 
reach Day 28 without having received a rescue medication 
• 
The use of established anti-malarial drug combination per WHO recommendations and per 
local regulations and the choice of the best therapeutic option is left at investigator’s 
decision. 
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Clinical Trial Protocol 
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Statistical considerations: 
• 
Primary analysis: Logistic regression with p: probability of a response in PCR-corrected 
ACPR at Day 28 and OZ439 AUC and FQ AUC0-Day28 (SSR97213 AUC0-Day28 will be 
considered also) and baseline parasitemia as covariates will be fitted. The Wald test will 
be used to test the OZ439 exposure effect on PCR-corrected ACPR at Day 28. 
• 
Analysis of secondary endpoints:  
- 
Dose effect analysis:  
A generalized multiple comparison procedures-modeling (MCP-Mod) approach will 
be used with PCR-corrected and crude ACPR at Day 28. Both linear and log model 
will be fitted. Then the dose response signal will be tested via contrasts based on dose-
response shape. 
Clearance rate estimation according to worldwide antimalarial resistance network 
(WWARN) (1). 
- 
Other activity endpoints:  
Cox model will be used for time to event endpoints with OZ439 doses and parasitemia 
at baseline as covariates, potential interaction will be explored.  
Mean values or percentage of participants, per treatment arm, reaching each of the 
secondary endpoints, will be calculated according to the type of endpoint (quantitative 
or qualitative) with the corresponding 95% confidence interval (CI). 
Safety analyses will be descriptive.  
The on-treatment phase will be defined as the time of the first IMP administration 
(included) up to Day 28 (included). 
The PK parameters for different entities will be estimated through Bayesian analysis 
using previously developed population PK models. 
Descriptive statistics for OZ439, FQ and SSR97213 concentrations and PK parameters 
(Cmax, tmax, C168h, AUC, and t1/2 for all entities, AUC0-Day28 for FQ and SSR97213 only) 
will be provided.  
 
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2 
SCHEDULE OF ACTIVITIES (SOA) 
 
Treatment Period and post-treatment surveillance (Days) 
Follow-up (Days) 
0a 
1 
2 
3 
4 
5 
6 
7 
Hours post-dose 
Procedure 
Screening 
(up to 1 
day before 
Day 0) 
0 
1 2 
4 
6 
8 
12 
18 
24 
30 
36 
48 
72 
96 
120 
144 
168 
10 
14
±1 
21
±
2 
28 
±2 
Visit 
1b 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13c 
Notes 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demography, medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/ exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRT call 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hospitalization 
Å======================================================Æ••••••••••••Æ 
 
 
 
 
 
 
 
All patients hospitalized for 
48 h post dosing or  up to 
4 days in case malaria 
symptoms and/or 
parasitemia persist at the 
end of day 2 or longer upon 
investigator’s judgment 
Treatment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FQ  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OZ439 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dosing in fasted 
condition (see Section 
6.3.1) 
Rescue therapyd 
 
Å 
•••    •••    •••   •••    •••    •••    •••  
••• 
••• 
••• 
••• 
••• 
••• 
••• 
••• 
••• 
••• 
•• 
X 
 
Prior and concomitant medication 
X 
X 
 
 
 
 
 
 
 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
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Clinical Trial Protocol 
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Treatment Period and post-treatment surveillance (Days) 
Follow-up (Days) 
0a 
1 
2 
3 
4 
5 
6 
7 
Hours post-dose 
Procedure 
Screening 
(up to 1 
day before 
Day 0) 
0 
1 2 
4 
6 
8 
12 
18 
24 
30 
36 
48 
72 
96 
120 
144 
168 
10 
14
±1 
21
±
2 
28 
±2 
Visit 
1b 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13c 
Notes 
Activity 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical exam & malaria signs & 
symptoms 
X 
 
 
 
 
 
 
X 
 
X 
 
X 
X 
(X) 
(X) 
 
 
X 
 
 
 
X 
Physical exam to be 
performed at discharge 
from the hospital 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight 
X 
 
 
 
 
 
 
 
 
 
 
 
(X) 
(X) 
(X) 
 
 
 
 
 
 
X 
Weight to be taken at 
discharge from hospital 
Temperature (single)e 
X 
 
X X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Asexual & sexual parasite count 
(thick & thin blood films)e 
X 
 
 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
qPCR, parasite genotyping, RT-
qPCR gametocyte detection 
samplingf 
X 
 
 
 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Measurement required 
within 4 hours prior to 
dosing 
 
Safety 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-Lead ECGg 
X 
X 
 
X X X 
X 
X 
 
X 
 
 
X 
(X) 
(X) 
 
 
X 
 
 
 
 
72 and 96 h post-dose if 
participant still hospitalized 
Vital signs   
X 
 
 
 
 
X 
 
X 
 
X 
 
 
X 
(X) 
(X) 
 
X 
X 
X 
X 
X 
X 
Vital signs to be taken at 
discharge from the hospital 
AEs 
Å====================================================================================================Æ 
 
Laboratory testing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical laboratory safetyh 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
(X) 
(X) 
 
 
X 
 
X 
X 
X 
72 and 96 h post-dose if 
participant still hospitalized 
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Treatment Period and post-treatment surveillance (Days) 
Follow-up (Days) 
0a 
1 
2 
3 
4 
5 
6 
7 
Hours post-dose 
Procedure 
Screening 
(up to 1 
day before 
Day 0) 
0 
1 2 
4 
6 
8 
12 
18 
24 
30 
36 
48 
72 
96 
120 
144 
168 
10 
14
±1 
21
±
2 
28 
±2 
Visit 
1b 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13c 
Notes 
Viral hepatitis serology 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
rapid spot test (HAV IgM, 
HBsAg, HCV Ab), and/or 
HCV RNA (if known) 
Pregnancy test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Urine beta-HCG is the 
minimum acceptable test. 
Result must be confirmed 
negative prior to dosing. 
PK OZ439i 
 
X 
X X X 
X 
 
X 
 
X 
 
 
X 
X 
 
X 
 
X 
 
X 
 
 
Not measured in Arm A; 
Plasma samples 
PK FQ (+metabolite)i 
 
X 
X 
 
X 
X 
X 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
a Day 0 is defined as the day of single dose treatment to comply with WHO guidelines (2). 
b Visit 1 may occur on the same day as Visit 2 provided that all baseline assessments and biology results (including parasitemia and laboratory safety) are obtained before patient randomization. 
c In case of study discontinuation, all assessments planned on Day 28, including rescue therapy administration, should be performed as far as possible. 
d Administered at Day 28 for participants who reach Day 28 without having received a rescue medication. At each contact post-dosing, conditions for treatment failure will be assessed and rescue therapy will be 
given accordingly. See details in Section 7.7.1. 
e Local thick and thin blood films performed at the site, before Informed Consent signature, according to local standard procedures and within 4 hours prior to dosing, can be used  as screening/ pre-dose 
parasitemia assessments (Section 9.1.1.1) provided that a standard procedure is in place at site and blood films staining is performed according to the study operational manual. Blood films (thick and thin) and 
temperature measurements need to be confirmed as follows: when 1st parasite clearance and 1st temperature < 37.5 °C,  measurements need to be confirmed with second reading 6 to 12 hours after the first 
measurement (ie, to determine Parasite Clearance and Fever Clearance). The first measurement (if confirmed) will be considered the 'Clearance Time'. Asexual and sexual counts will be measured separately: 
only asexual count will be used as parasitemia for evaluation of study endpoints. If parasites have not cleared within 72 hours after IMP administration and criteria for rescue medication are not met at 72 hours 
post-dose, blood films should continue to be taken according to site standard practice (or at minimum every 8 hours) until parasite clearance is shown or until criteria for rescue medication are met (see 
Section 7.7.1). If these additional blood smears are taken they should be recorded as unscheduled visits in the e-CRF. Axillary temperature should be recorded, if the axillary method is not possible, an alternative 
route (oral, tympanic, rectal) may be used. Within an individual participant the same method of temperature measure should be used throughout the study. 
f 
RT-qPCR and qPCR will be performed at all parasitemia time-points (To be collected, according to the schedule and the instructions reported in the study operational manual). Parasite genotyping analysis will be 
performed on previously collected blood spot sample only in case of a positive blood film after initial parasite clearance: one pre-dose sample and one sample at 18 or 24 hours post dosing. A further sample will be 
analyzed at the time point at which recrudescence/re-infection occurs (if applicable). 
g Single local ECG reading for inclusion purpose and triplicate central ECG reading for safety evaluation during study. 
h Laboratory safety will be performed locally: hematology, clinical chemistry, and urinalysis (see Appendix 2 for details). 
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i 
Where timepoints coincide, the PK samples should be taken after measurement of vital signs, temperature, and ECG. A PK sample (OZ439 and FQ) should be obtained if possible when QTcF >500 ms or QTcF is 
prolonged by >60 ms from baseline, or when increased ALT is measured (see Section 9.2). PK samples numbering is detailed in Table 3. 
AE: adverse event; e-CRF: electronic case report form; ECG: electrocardiogram; FQ: ferroquine; HAV IgM: hepatitis A immunoglobulin M; HBsAg: hepatitis B surface antigen; HCG: human chorionic gonadotropin; 
HCV Ab: hepatitis C virus antibody; HCV RNA: hepatitis C virus ribonucleic acid; IMP: investigational medicinal product; IRT: Interactive response technology; PK: pharmacokinetics; qPCR: quantitative polymerase 
chain reaction; RT-qPCR: quantitative reverse transcription polymerase chain reaction; WHO: World Health Organization 
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3 
INTRODUCTION 
Sanofi and MMV are co-developing an FDC of FQ (investigational new drug IND-115244) and 
artefenomel (OZ439) (IND-104549) for a single dose treatment of uncomplicated malaria in 
adults and children.  
OZ439 is a novel, synthetic trioxolane that shows promising parasiticidal activity as a peroxidic 
anti-malarial agent. Refer to the investigator’s brochure (IB) (3) for details. 
Ferroquine is a new 4-aminoquinoline analogue (ferrocenyl derivative of chloroquine) active 
against chloroquine-resistant and sensitive P. falciparum strains. Ferroquine is metabolized into 
one major metabolite (N-demethyl derivative, SSR97213), equally active in vitro on chloroquine-
sensitive strain.  
3.1 
STUDY RATIONALE 
When the clinical development of OZ439/FQ will be completed with phase 3 studies, Sanofi and 
MMV intend to submit a new drug application (NDA) for registration at United States Food and 
Drug Administration (USFDA). 
Per FDA guidance (4) for co-development of 2 new investigational drugs or new chemical entities 
for use in combination, it is recommended to demonstrate the contribution of each individual 
component to the effect of the combination.  
Contribution of FQ to the combination will be demonstrated in the ongoing OZ439/FQ phase 2b 
trial (DRI12805) in which clinical efficacy of 4 doses of FQ (400, 600, 900 and 1200 mg) 
associated with a fixed dose of 800 mg of OZ439 will be analyzed using an efficacy endpoint to 
show a dose effect.  
This phase 2a study will evaluate the contribution of OZ439 to the effect of the combination by 
testing clinical and parasiticidal activity, PK and safety of 3 doses of OZ439 associated with a 
fixed dose of FQ and FQ alone in African adults and adolescents as of 14 years of age and 
affected with uncomplicated P. falciparum malaria. The reason for not including younger children 
in the study is to avoid administering sub-therapeutic treatment to a young population that is more 
susceptible to severe malaria. In addition, it is common to perform an activity phase 2a study in an 
adult population. 
The primary objective of the study will be to show the contribution of OZ439 to the clinical and 
parasiticidal effect of OZ439/FQ combination by analyzing exposure-response of OZ439 
measured by Day 28 PCR-corrected ACPR for the effect and the AUC of OZ439 as PK predictor.  
Provided that the 400 mg FQ dose administered to all patients in this study is the minimal dose 
tested in the Phase 2b study (DRI12805) and that the present study will investigate the role of 
OZ439, a drug with a short/mid half-life, in the activity of the drug association, a 28 days follow-
up may be sufficient to properly evaluate the activity while ensuring good safety assessment. 
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3.2 
BACKGROUND 
Despite a decline of 41% of malaria incidence rate and 62% of malaria mortality from 2000 to 
2015, P. falciparum malaria remains a deadly endemic parasitic disease, with 212 million new 
cases reported in 2015. P. falciparum malaria killed over 429,000 people in 2015, 92% of them 
living in Africa and 70% being children less than 5 years of age (5).  Malaria is curable and 
preventable: principal control strategies including rapid diagnosis, effective treatment and 
personal protection with bed nets. World Health Organization guidelines (6) recommend that 
ACTs are used to treat uncomplicated P. falciparum malaria to counter the threat of resistance of 
P. falciparum to monotherapies and to improve treatment outcome. Artemisinin derivatives 
produce rapid clearance of parasitemia and resolution of symptoms and needs a 3 day regimen 
when given in combination with slowly eliminated anti-malarial drugs such as 4-aminoquinoline 
drugs. With this shorter 3-day course, the complete clearance of all parasites is dependent on the 
partner medicine being effective and persisting at parasiticidal concentrations until all infecting 
parasites have been killed. 
However evidence suggests that access to ACTs and compliance to the 3-day treatment course is 
not optimal, particularly in children (7). A once daily dosing has been proven to offer improved 
adherence as compared to twice daily regimen (5), while 3 days ACTs have improved adherence 
as comparted to longer regimens used before (6). A single dose antimalarial treatment could offer, 
for the first time, the realistic potential for optimal adherence. 
In addition, evidence of emergence of potential plasmodial resistance to artemisinin 
(8,9,10,11,12,13) and more recently piperaquine phosphate (PQP) (14,15) suggests that resistance 
to ACT components may become an issue in the coming years. Thus, new drug combinations with 
new mode of action are required to treat sensitive and resistant genotypes of P. falciparum, and 
effective single exposure combination treatments in particular are likely to lead to significant 
improvement in real-life effectiveness. 
Ferroquine has been tested on various clinical isolates (chloroquine-sensitive, chloroquine-
resistant, artemisinin and PQP resistant and multi-drug resistant), from South East Asia and from 
Africa, and displayed a very potent antimalarial activity against P. falciparum with no cross-
resistance with other anti-malaria drugs. Refer to the FQ IB (16) for details. 
3.3 
BENEFIT/RISK ASSESSMENT 
The benefit and risk assessment of OZ439/FQ administered in combination in the Phase 2a 
ACT14655 study and the safety evaluation are based on nonclinical data and on clinical data from 
completed studies as of cut-off date of the referring respective IBs.  
The primary AEs reported were mainly gastrointestinal (nausea, vomiting) and nervous system 
(headache, dizziness) events. However, based on nonclinical and clinical data analyses of OZ439 
and FQ, hepatic effect (elevated liver enzymes) and proarrhythmic effect (QT interval corrected 
using Fridericia formula [QTcF] prolongation) are the identified risks for the individual 
components OZ439 and FQ given alone or in combination. Participants will be closely monitored 
for hepatic and cardiac conduction effects. Since this is an investigational study designed to 
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determine the contribution of OZ439 to the effect of the combination OZ439/FQ, participants 
enrolled in some of the 4 arms of the study might receive sub-therapeutic drug treatment. This risk 
will be properly mitigated by the fact that only adults and adolescents as of 14 years of age and 
presenting with uncomplicated P. falciparum malaria are eligible, and that participants will be 
hospitalized in a well-equipped health center for at least 48 h or up to 4 days in case malaria 
symptoms and/or parasitemia persist, or longer upon investigator’s judgment. Participants will 
receive a standard rescue therapy as soon as there is evidence of treatment failure or 
systematically on Day 28 for the ones who reach Day 28 without having received a rescue 
medication.  
Justification for the selected doses of IMP is provided in Section 5.5. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of OZ439 and FQ may be found in the respective IBs (3, 16). 
 
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4 
OBJECTIVES AND ENDPOINTS 
Table 1 - Objectives and endpoints 
Objectives 
Endpoints 
Primary 
• 
To show the contribution of OZ439 to 
the clinical and parasiticidal effect of 
OZ439/FQ combination by analyzing 
exposure-response of OZ439 measured 
by Day 28 PCR-corrected ACPR for the 
effect and the AUC of OZ439 as PK 
predictor 
• 
Day 28 PCR-corrected ACPR (see 
Section 10.3.1.1 for details) 
 
Secondary 
• 
To evaluate the dose response of OZ439 
combined with FQ on PCR-corrected 
and crude Day 28 ACPR 
• 
Day 28 PCR-corrected ACPR (see 
Section 10.3.1.1 for details) 
• 
Day 28 crude ACPR (see Section 
10.3.1.1 for details) 
• 
To evaluate the dose-response of OZ439 
combined with FQ on selected 
secondary endpoints  
• 
Parasitemia (/µl) at baseline then every 
6 h during the first 36 h then at 48 h and 
every 24 h until Day 7 
• 
observed PRR at 24 h, 48 h, and 72 h 
• 
time (h) to 99% parasite reduction  
• 
time (h) to parasite clearance 
• 
Parasite clearance rate 
• 
time (h) to recrudescence or re-infection 
• 
time (h) elapsed below LOQ of 
parasitemia 
• 
To evaluate the safety and tolerability of 
different dosages of OZ439 in 
combination with FQ and FQ alone 
• 
AEs including  SAEs, AESIs and 
TEAEs  
• 
Clinical laboratory  tests (including 
LFT), vital signs, and ECG including 
QTc assessment 
• 
Physical examination and clinical signs 
and symptoms related to uncomplicated 
P. falciparum malaria (fever, dizziness, 
headache, nausea, anorexia, vomiting, 
diarrhea, itching, urticaria, skin rash, 
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Objectives 
Endpoints 
abdominal pain, joint pain, muscle pain, 
palpitations, sleep problems, confusion, 
hearing problems, vision problems, and 
fatigue). 
• 
To characterize the PK of OZ439 in 
plasma, and of FQ and its active 
metabolite SSR97213 in blood 
• 
Concentrations of OZ439 in plasma, 
and of FQ and SSR97213 in blood at 
specific time points  
• 
PK parameters for OZ439 in plasma, 
and for FQ and SSR97213 in blood, 
including: 
- 
Cmax 
- 
tmax 
- 
C168h 
- 
AUC 
- 
t1/2 
• 
AUC0-Day 28 for FQ and SSR97213 only 
Tertiary/exploratory 
• 
To explore the impact of study 
treatment on functional gametocytemia 
• 
Quantitative reverse transcription 
Polymerase Chain Reaction (RT-qPCR) 
to measure gametocyte maturation stage 
(expression of Pfs25 mRNA)   
• 
To evaluate the relationship between 
parasitemia and concentration of 
OZ439/FQ  
• 
Quantitative Polymerase Chain 
Reaction (qPCR) and RT-qPCR to 
explore, at all parasitemia time-points, 
the PK/PD of OZ439/FQ (to be reported 
in a separate report). 
• 
To evaluate the relationship between 
QTc and concentration of OZ439/FQ 
• 
QTcF to explore, at all ECG time-
points, the PK/PD of OZ439/FQ 
4.1 
APPROPRIATENESS OF MEASUREMENTS 
Day 28 PCR-corrected ACPR is an appropriate measure of the clinical and parasitological activity 
of the OZ439/FQ combination on the P. falciparum infection, reflecting both early parasite 
clearance and long lasting sterilization along a 28 days period.  
A previous exposure-response analysis of data from MMV_OZ439_13_003 has demonstrated that 
both OZ439 and PQP contributed to the overall efficacy of the combination (17). Then, exposure 
(AUC) has been selected as PK predictor in the primary analysis based on previous internal data 
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(from MMV in the context of OZ439/PQP and from sanofi in the context of FQ/artesunate) 
indicative that it is a good predictive marker of parasiticidal activity (similar to C168h).  
At this stage of the clinical development, the effective dose of OZ439 and FQ selected to be tested 
in large scale phase 3 trials is unknown and the range of exposure and effect associated with the 
3 individual selected OZ439 doses cannot be anticipated.  
Modeling and simulations (M&S) show that OZ439 exposure-effect analysis may be a proper way 
to analyze and conclude on OZ439 contribution as well as dose-effect analysis, while needing 
fewer  participants and maintaining an appropriate statistical power. A PK/PD model will be built 
specifically for OZ439/FQ combination. A similar model was used in an OZ439/PQP phase 2b 
study and it demonstrated the contribution of OZ439 in the OZ439/PQP combination using the 
same endpoint and analysis method (17).  
Secondary objectives of the study will evaluate the dose-response of OZ439 on Day 28 PCR 
corrected ACPR and selected secondary activity endpoints (time to parasite clearance, time to 
99% parasite reduction, ratio of participants with parasitemia at Day 4, observed PRR, estimated 
parasite clearance rate (1), time to recrudescence or re-infection, time LOQ of parasitemia, Day 28 
crude ACPR). Secondary objectives will also evaluate the safety and tolerability of OZ439/FQ 
combination with dose ranging of OZ439 and will characterize the PK of OZ439 in plasma, and 
of FQ and its active metabolite SSR97213 in blood. 
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5 
STUDY DESIGN 
5.1 
OVERALL DESIGN 
This is a phase 2a, randomized, open label, parallel-group study, single-dose regimen, testing 
3 dose levels of OZ439 given in combination with FQ and FQ alone in patients with 
uncomplicated P. falciparum malaria. 
The study will be organized in up to 10 sites in Sub Saharan African countries with malaria 
transmission. Adults up to 69 years old and adolescents as of 14 years old will be included in 
4 parallel arms in a 1:1:1:1 randomization ratio.  
Participants will receive one of the 4 combinations: FQ 400 mg alone or combined with 
OZ439 300 mg, 600 mg or 1000 mg. Doses will not be adjusted to participant weight. 
Participants will be hospitalized for the first 48 hours or up to 4 days in case malaria symptoms 
and/or parasitemia persist, or longer upon investigator’s judgment. Following discharge, 
participants will return to the site for further assessments up to Day 28. A rescue treatment will be 
systematically administered on Day 28 for participants who reach Day 28 without having received 
a rescue medication. 
Study will last for up to 32 days for each participant: 
• 
Up to 1 day screening period before the single-dose treatment 
• 
5 days of post-treatment surveillance, including 2 to 4 days hospitalization 
• 
24±2 days follow-up 
 
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Figure 1 - Graphical study design 
V1
Screening
1 day
V2
Day -1
admission
Screening 
procedures
Day 0
Inclusion 
Randomization
IMP administration
V3
V4
V5
V6
V7
V8
V9
V10
V11
V12
V13
D1
D2
D3 D4 D5 D6
D7
D10
D14 +/- 1
D21 +/- 2
D28 +/- 2
Hospitalization
Treatment Period and
post-treatment
surveillance
Follow-Up
N 
participants
Single dose 
OZ439 (mg)
Single Dose 
FQ (mg)
Arm A
~35
0
400
Arm B
~35
300
400
Arm C
~35
600
400
Arm D
~35
1000
400
4 arms
Note: Visits 1 & 2 can occur on the same day ; Visit 13 : assessment of primary endpoint
   IMP: Investigational Medicinal Product 
5.2 
PARTICIPANT AND STUDY COMPLETION 
Participants will be screened to achieve 140 randomly assigned to study treatment and 
120 evaluable participants for an estimated total of 30 evaluable participants per treatment group. 
Details on sample size determination are provided in Section 10.1.  
Evaluable participants are defined as all randomized participants with parasitologically confirmed 
malaria at baseline, who received the single administration of IMP and who have parasitemia data 
post-randomization (Section 10.2). 
5.3 
END OF STUDY DEFINITION 
A participant is considered to have completed the study if he/she has completed all phases of the 
study including the last visit (ie, Day 28). 
The end of the study is defined as the date of the last visit of the last participant in the study. 
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5.4 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
There are 3 aspects to consider to define most appropriate baseline parasitemia for the selection of 
the participants in the study: 
• Baseline parasitemia is a strong covariate of parasiticidal activity and clinical efficacy. A 
phase 2b study testing OZ439 and PQP performed by MMV (MMV_OZ439_13_003) 
showed that baseline parasitemia is strongly correlated with clinical efficacy (Day 28 
PCR-corrected ACPR), meaning that efficacy may increase when baseline parasitemia 
decreases, making more difficult to show a significant difference in efficacy across study 
arms. On the other hand increasing baseline parasitemia may not facilitate the recruitment 
of adult participants living in endemic places.  
• There is also a need to minimize the risk of re-infection during the trial in participants 
receiving FQ 400 mg to keep sufficient evaluable patients in each arm while allowing to 
enroll 140 patients in a reasonable timeframe and discriminating levels of activity across 
study groups. A baseline parasitemia of ≥3000 parasites/µl is a good compromise that 
would meet both requisites and allow participants recruitment in places with moderate 
transmission and low risk of re-infection during the study. 
• 
A baseline parasitemia ≥3000 parasites/µl is deemed to enlarge candidate site list, 
accelerate participant recruitment and minimize risk of re-infection during the study while 
keeping an adequate power. It will also minimize the risk of progression to severe malaria 
in a context of low dose of OZ439 in some groups. 
5.5 
JUSTIFICATION FOR DOSE 
Malaria therapy is constrained by WHO’s guidance that is recommending to treat an 
uncomplicated P. falciparum malaria with a combination of 2 highly potent and active drugs 
having a different mode of action with the objective to treat the infection and prevent resistance to 
the drugs (6). 
The efficient minimal dose of FQ will be confirmed in the ongoing phase 2b trial (DRI12805). 
However, there is some evidence that FQ is a highly potent drug. Therefore it may be difficult to 
show a significant effect ranging of OZ439 within the combination if the FQ dose level is too 
high.  
In this study, a dose of 400 mg of FQ was selected (this is one of the doses tested in the 
DRI12805). This dose is low enough to leave room for added efficacy attributed to OZ439. This 
dose will minimize the risk to see FQ effect hiding OZ439 effect and optimize the chance to show 
an effect ranging across the 4 groups tested in this study. Modeling and simulations indicate that 
efficacy of FQ 400 mg when given alone (PCR corrected Day 28 ACPR) may be around 72%, 
leaving room for increased efficacy related to OZ439 to less than 20%. 
Participants enrolled in some of the 4 groups of the study might receive sub-therapeutic dose of 
drug combination, however only adults and adolescents as of 14 years of age and presenting with 
uncomplicated malaria with ≤50,000 asexual parasites/µL of blood will be enrolled, both 
measures mitigating the risk of development of a severe malaria. They will be hospitalized for at 
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least 48 h in a well-equipped health center and will receive a standard rescue therapy as soon as 
there is evidence of treatment failure. In addition to initial hospitalization, patients will have 
frequent assessments (biweekly after the hospitalization through Day14 and weekly thereafter 
through the end of the study), and they will receive a rescue therapy at Day 28 even without signs 
of treatment failure. All these measures will mitigate the risk of malaria management failure.  
To optimize the likelihood to observe a difference on the primary endpoint (Day 28 PCR 
corrected ACPR) over the various doses of OZ439, FQ 400 mg will be administered alone or with 
OZ439 at a dose of 300, 600 or 1000 mg, while OZ439 800 mg is being tested in the ongoing 
OZ439/FQ DRI12805 phase 2b study. 
The rationale to include a group receiving 1000 mg of OZ439 is based on: 
• OZ439 was tested in phase 2a studies up to a single dose of 1200 mg (powder in bottle 
formulation with a glass of milk), with no particular safety issue, 
• Increasing the range of effect across the 4 study groups. M&S show that including extreme 
doses (0 and 1000 mg) will help. 
 
 
• Modeling and simulation show a significant exposure-effect with good power and limited 
number of participants, 
• 
An interest in framing the 800 mg OZ439 dose that is being tested in the Phase 2b, to 
comfort the assumption that this will be the optimal dose to carry forward into phase 3 
trials. 
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6 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
6.1 
INCLUSION CRITERIA 
Participants are eligible to be included in the study only if all of the following criteria apply: 
Age 
I 01. Participant must be 14 to 69 years of age inclusive, at the time of signing the informed 
consent. 
Type of participant and disease characteristics 
I 02. Participants who present with uncomplicated P. falciparum malaria, with a fever as 
defined with axillary temperature ≥37.5 degree Celsius (°C) or oral/ rectal/ tympanic 
temperature ≥38°C or history of fever in the previous 24 hours (history of fever must be 
documented), with a mono-infection with P. falciparum and parasitemia (microscopically, 
blood smear) ≥3,000 and ≤50,000 asexual parasites/µL of blood. 
Weight 
I 03. Body weight within 35 and 90 kg (inclusive). 
Sex 
I 04. Male and female 
a) Male participants: A male participant must agree to use contraception as detailed in 
Appendix 5 of this protocol for 3 months after the last dose of study treatment and 
refrain from donating sperm during this period.  
b) Female participants: A female participant is eligible to participate if she is not pregnant 
(see Appendix 5), not breastfeeding, and at least one of the following conditions 
applies: 
- 
Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 
OR 
- 
A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 for 
3 months after the last dose of study treatment. 
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Informed Consent 
I 05. Capable of giving signed informed consent (if the patient is ≥age defining majority) as 
described in Appendix 3, which includes compliance with the requirements and restrictions 
listed in the informed consent form (ICF) and in this protocol. Informed consent signed by 
the legally acceptable representative (LAR) of the minor patient (<18 years of age or 
<other age locally defining majority). In addition, in accordance with local regulation, 
minor participants with capacity for writing could sign off on an Assent Form. For those 
who are able to understand but with no capacity for writing the Assent Form would be 
read. In that case, an impartial witness could certify the document was read to the child. 
6.2 
EXCLUSION CRITERIA  
Participants are excluded from the study if any of the following criteria apply: 
Medical conditions 
E 01. Presence of severe malaria (6, 7) 
E 02. Known history or evidence of clinically significant gastrointestinal, cardiovascular, 
hepatic, renal, hematological, respiratory, endocrine, immunological, infectious, 
neurological (in particular convulsions), malignancy,  psychiatric disease or symptoms 
which, in the judgment of the investigator, might confuse the interpretation of the safety 
information 
E 03. Severe vomiting defined as more than 3 times in the 24 hours prior to enrollment in the 
study or inability to tolerate oral treatment or severe diarrhea defined as 3 or more watery 
stools per day 
E 04. Severe malnutrition defined as a body mass index of less than 16 kg/m² (18) for adults and 
for children Z-score <-3 or weight for age (%) of the median <60 
E 05. Splenectomized participants or presence of surgical scar on left hypochondrium 
E 06. Known history of hypersensitivity, allergic, or anaphylactoid reactions to FQ or other 
amino quinolines or to OZ439 or OZ277 or any of the excipients 
Prior/concomitant therapy 
E 07. Participant treated with anti-malarial treatment: 
- 
With PQP-based compound, mefloquine, naphthoquine or 
sulphadoxine/pyrimethamine within the previous 6 weeks. 
- 
With amodiaquine or chloroquine within the previous 4 weeks. 
- 
With quinine, halofantrine, lumefantrine-based compounds and any other anti-malarial 
treatment or antibiotics with antimalarial activity (including cotrimoxazole, 
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tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 
14 days. 
- 
With any herbal products or traditional medicines, within the past 7 days 
E 08. Previous treatment within 5 times the half-life or within the last 14 days, whichever the 
longest, which are: strong CYP2C or CYP3A inhibitors and/or moderate inhibitors but 
inhibiting both CYP2C and CYP3A and/or CYP inducers (Appendix 6) 
E 09. Any treatment known to induce a prolongation of QT interval (Appendix 6) 
Prior/concurrent clinical study experience 
E 10. Participated in any trial investigating OZ439 and/or FQ compounds 
E 11. Previous participation in any malaria vaccine study or received malaria vaccine in any 
other circumstance 
E 12. Enrolled in another clinical trial within the past 4 weeks or during the study period 
Diagnostic assessments 
E 13. Mixed Plasmodium infection 
E 14. Presence of Hepatitis A – immunoglobulin M (HAV-IgM), Hepatitis B surface antigen 
(HBs Ag) or Hepatitis C virus antibody (HCV Ab) and/or known to have active Hepatitis 
C virus RNA (HCV RNA) 
E 15. Laboratory parameters with abnormalities deemed clinically significant by the investigator.  
E 16. Abnormal LFT: aspartate transferase (AST) >2 upper limit of normal range (ULN), or 
alanine transferase (ALT) >2 ULN or total bilirubin >1.5 ULN 
E 17. Positive pregnancy test at study screening for female participants of childbearing potential 
E 18. QTcF >450 ms at screening or pre-dose 
E 19. Hypokalemia (<3.5 mmol/L), hypocalcemia (<2.0 mmol/L) or hypomagnesemia 
(<0.5 mmol/L) at screening or pre-dose 
Other exclusions 
E 20. Any country-related specific regulation that would prevent the subject from entering the 
study - see Appendix 9 (country specific requirements) 
E 21. Family history of sudden death or of congenital prolongation of the QT interval or known 
congenital prolongation of the QT-interval or any clinical condition known to prolong the 
QT interval e.g., participants with a history of symptomatic cardiac arrhythmias including 
atrial fibrillation (AF) or with clinically relevant bradycardia 
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E 22. Patient not suitable for participation, whatever the reason, as judged by the Investigator, 
including medical or clinical conditions, or patients potentially at risk of noncompliance to 
study procedures or unable to drink 
6.3 
LIFESTYLE RESTRICTIONS 
6.3.1 Meals and dietary restrictions 
1. No food or milk is allowed within 3 hours before dosing and until 2 hours after dosing. 
2. No water is allowed until 2 hours after dosing, after which time, water is allowed ad 
libitum. 
6.4 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently randomly assigned to study treatment. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants to meet the 
Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to respond 
to queries from regulatory authorities. Minimal information includes demography, screen failure 
details, eligibility criteria, and any SAE. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened only for a subsequent malaria episode. 
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7 
TREATMENTS 
Study treatment is defined as any investigational treatment(s), marketed product(s), placebo, or 
medical device(s) intended to be administered to a study participant according to the study 
protocol. 
7.1 
TREATMENTS ADMINISTERED 
Table 2 - Overview of treatments administered 
Study treatment name 
Arm A 
Arm B 
Arm C 
Arm D 
Dosage formulation 
FQ 
FQ + OZ439 
FQ + OZ439 
FQ + OZ439 
Dosage level :  
FQ 
 
 
OZ439 
400 mg 
- 
400 mg 
300 mg 
400 mg 
600 mg 
400 mg 
1000 mg 
Route of administration 
oral 
oral 
oral 
oral 
Dosing instructions 
Single dose 
Fasted condition 
 
Single dose 
Fasted condition 
FQ then OZ439 
Single dose 
Fasted condition 
FQ then OZ439 
Single dose 
Fasted condition 
FQ then OZ439 
Packaging and labeling 
Study treatment will be provided in open label treatment box. Each box will be labeled as required 
per country requirement. Packaging is in accordance with the administration schedule. 
Content of each box: 
1 wallet of FQ 400 mg 
1 wallet of 400 mg FQ, 
1 sachet of 300 mg 
OZ439 +TPGS, and 1 
sachet of 5.625 g 
sucrose 
1 wallet of 400 mg 
FQ, 1 sachet of 
600 mg OZ439 
+TPGS, and 1 sachet 
of 11.25 g sucrose 
1 wallet of 400 mg 
FQ, 1 sachet of 
400 mg OZ439 
+TPGS, 1 sachet of 
600  mg OZ439 
+TPGS, and 1 sachet 
of 18.75 mg sucrose 
Manufacturer 
SANOFI Montpellier 
SANOFI Montpellier 
SANOFI Montpellier 
SANOFI Montpellier 
7.1.1 Investigational Medicinal Products 
All details regarding the preparation of IMPs, including suspension OZ439, will be described in 
the operational manual. 
7.1.1.1 Ferroquine 
A combination of the 100 mg FQ capsules will be used to compose the 400 mg FQ single dose. 
FQ will be administered orally on Day 0 in fasted condition (see Section 6.3.1 for details). 
No re-dosing of FQ will be performed if a patient vomits during or after FQ administration but 
before OZ439 administration. In that case, OZ439 will not be administered and the patient will 
receive a rescue therapy as per Section 7.7.1. 
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7.1.1.2 OZ439 
Individual sachets contain OZ439 granules (dose strengths 300, 400 and 600 mg) and TPGS 
granules for oral suspension. Sucrose granules for oral suspension will be provided in separate 
sachets and will be added to the OZ439 + TPGS aqueous oral suspension to make it palatable. 
OZ439 will be administered orally after the FQ administration. The suspension will have to be 
drunk within 2 hours and 20 minutes of the start of its preparation, as quickly as possible and over 
a maximum of 30-minute period. 
• 
If a participant vomits within 5 minutes of the start of dosing with OZ439, they will be re-
dosed with a freshly prepared new suspension from a new individual patient treatment kit 
assigned via interactive response technology (IRT). No re-dosing of FQ will be performed.  
- 
If the participant vomits again within 35 minutes after re-dosing, they will receive a 
rescue therapy as per Section 7.7.1. 
• 
If vomiting occurs from 5 minutes to 35 minutes post start of OZ439, they will continue to 
take the OZ439 dose (if any left), but will not be re-dosed. 
• 
If a patient vomits after 35 minutes from the start of OZ439 dosing, they will not be re-
dosed. 
7.1.2 Noninvestigational Medicinal Products 
Rescue therapy will be administered to all participants, either before Day 28 if demanded by the 
participants health status (see Section 7.7.1 for details), or at Day 28 for participants who reach 
Day 28 without treatment failure. 
Rescue therapy consists of established anti-malarial drug combination per WHO 
recommendations (6) and per local regulations and the choice of the best therapeutic option is left 
at investigator’s decision. 
7.2 
DOSE MODIFICATION 
Not applicable: this is a single-dose study. 
7.3 
METHOD OF TREATMENT ASSIGNMENT 
The randomized treatment kit number list will be generated centrally by Sanofi. The IMPs will be 
packaged in accordance with this list. 
Participants will be randomized to one of the treatment arms via a centralized randomization 
system using IRT. A participant will be considered randomized when the treatment number has 
been provided by the IRT, as documented in the IRT log file. 
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At the screening visit (Visit 1), the site will contact the IRT to obtain a participant number for 
each participant who gave an informed consent. The participant number will be associated with 
the center and allocated in chronological order in each center. 
IRT will manage one participant randomization list and allocate the treatment number and the 
corresponding treatment kit to the participant. 
Approximately 140 participants will be randomized to one of the 4 treatment arms of OZ439/FQ. 
The randomization ratio is 1:1:1:1 with FQ fixed at 400 mg and OZ439 doses will be 0, 300, 600 
and 1000 mg. 
A participant can be randomized only once. 
Centralized randomization and IRT-related procedures will be detailed in the study operational 
manual. 
7.4 
BLINDING 
Not applicable since this is an open label study using central randomization via IRT; the specific 
treatment to be taken by a participant will be assigned using IRT. The site will contact IRT prior 
to the start of study treatment administration for each participant.  
7.5 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
All details regarding the preparation of IMP will be described in the study operational manual. 
1. The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatment received and any discrepancies are 
reported and resolved before use of the study treatment. 
2. Only participants enrolled in the study may receive study treatment and only authorized 
site staff may supply or administer study treatment. All study treatments must be stored in 
a secure, environmentally controlled, and monitored (manual or automated) area with 
access limited to the investigator and authorized site staff in accordance with local 
regulations, labeled storage conditions, policies, and procedures. 
3. The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study treatment accountability, reconciliation, and record maintenance (ie, 
receipt, reconciliation, and final disposition records). 
4. Further guidance and information for the final disposition of unused study treatment are 
provided in the study operational manual.  
Any quality issue noticed with the receipt or use of an IMP/NIMP (deficiency in condition, 
appearance, pertaining documentation, labeling, expiration date, etc) must be promptly notified to 
the Sponsor. Some deficiencies may be recorded through a complaint procedure (see 
Section 9.2.8). 
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A potential defect in the quality of IMP/NIMP may be subject to initiation of a recall procedure 
by the Sponsor. In this case, the Investigator will be responsible for promptly addressing any 
request made by the Sponsor, in order to recall the IMP/NIMP and eliminate potential hazards. 
Under no circumstances will the Investigator supply IMP/NIMP to a third party, allow the 
IMP/NIMP to be used other than as directed by this clinical trial protocol, or dispose of 
IMP/NIMP in any other manner. 
7.6 
TREATMENT COMPLIANCE 
Measures taken to ensure and document treatment compliance and IMP accountability include: 
• 
The investigator or his/her delegate among the study personnel will monitor the 
administration of IMP and the IMP uptake will be recorded in the electronic case report 
form (e-CRF) 
• 
Proper recording of treatment kit number or packaging number as required on appropriate 
e-CRF page for accounting purposes 
• 
The pharmacist or designee will prepare the kit assigned by IRT, will complete the 
corresponding treatment log form, and will perform reconciliation by checking the 
consistency of the treatment number between IRT assignment notification, the treatment 
number printed on the kit boxes and the treatment log forms 
• 
IMP will also be recorded and tracked on the site IMP inventory forms 
• 
The monitor in charge of the study will check the data entered on the e-CRF by comparing 
them with the IMP that has been retrieved and the treatment log form 
• 
A detailed treatment log of the destroyed IMP will be established with the Investigator (or 
the pharmacist) and countersigned by the Investigator and the monitoring team. The 
Investigator will not destroy the unused IMP unless the Sponsor provides written 
authorization 
7.7 
CONCOMITANT THERAPY 
All drugs other than oral contraceptives, paracetamol (acetaminophen) at the maximum dose of 
40 mg/kg/day, metoclopramide if repeated vomiting and beta-lactams for any infection needing an 
antibiotic treatment are prohibited over the entire study period unless medically justified. The 
dosage and number of dose(s) will be recorded. The use of other contraceptive methods may be 
discussed. Traditional and herbal remedies are not permitted during the study. 
Appendix 6 is listing drugs that can interfere with OZ439 or FQ metabolism (strong cytochrome 
P450 [CYP] 2C or CYP3A inhibitors, moderate inhibitors inhibiting both CYP2C and CYP3A, 
and CYP inducers) or can be affected by OZ439 and FQ in their metabolism (CYP2D6 main 
substrates, P-glycoprotein [P-gp] substrate) and drugs that can increase QT interval. 
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Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, 
and/or herbal supplements) that the participant is receiving at the time of enrollment or receives 
during the study must be recorded along with: 
• 
Reason for use 
• 
Dates of administration including start and end dates 
• 
Dosage information including dose and frequency 
The Medical Monitor should be contacted if there are any questions regarding concomitant or 
prior therapy. 
7.7.1 Rescue medicine 
The study site will supply rescue medication that will be obtained locally upon local 
recommendation.  
The use of established anti-malarial drug combination per WHO recommendations (6) and per 
local regulations and the choice of the best therapeutic option is left at investigator’s decision. 
The use of rescue medications is allowed as soon as  
• 
vomiting occurs during FQ dosing or after FQ dosing but before OZ439 administration, 
• 
vomiting occurs within 35 minutes after OZ439 re-dosing (see Section 7.1.1.2), or 
• 
there is evidence of treatment failure (see definition below).  
If no rescue medication is administered before Day 28, it will be administered on Day 28. 
Treatment failure is defined according to WHO recommendations (2) as follows: 
Early treatment failure (one the following) 
• 
danger signs or severe malaria on Day 1, 2, or 3 in the presence of parasitemia; 
• 
parasite count on Day 2 higher than on Day 0, irrespective of axillary temperature; 
• 
parasitemia on Day 3 with axillary temperature ≥37.5°C; 
• 
parasite count on Day 3 ≥25% on Day 0. 
Late clinical failure 
• 
danger signs or severe malaria on any day between Day 4 and Day 28 in the presence of 
parasitemia, without previously meeting any of the criteria of early treatment failure; 
• 
presence of parasitemia and axillary temperature ≥37.5°C (or history of fever) on any day 
between Day 4 and Day 28, without previously meeting any of the criteria of early 
treatment failure. 
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Late parasitological failure 
• 
presence of parasitemia on any day between Day 7 and Day 28 and axillary temperature 
<37.5°C, without previously meeting any of the criteria of early treatment failure or late 
clinical failure. 
Before giving a rescue therapy before Day 28, where possible: 
• 
a PK (OZ439 and FQ) sample should be taken 
• 
blood films, parasite genotyping, RT-qPCR, and qPCR  must be taken 
Following administration of rescue therapy before Day 28, patients should be managed according 
to local standard of care practices. Safety data, parasitemia (blood films), and PK data should 
continue to be collected in the e-CRF, according to the study schedule, and up to the end of the 
study (Day 28) even if re-emergence is confirmed. 
7.8 
TREATMENT AFTER THE END OF THE STUDY 
No treatment will be provided after the end of the study. 
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8 
DISCONTINUATION/WITHDRAWAL CRITERIA  
8.1 
DISCONTINUATION OF STUDY TREATMENT  
Not applicable: this is a single-dose study. 
8.2 
WITHDRAWAL FROM THE STUDY 
A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. 
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, he/she may request destruction of any samples taken 
and not tested, and the investigator must document this in the site study records. 
See SoA for data to be collected at the time of study discontinuation and follow-up and for any 
further evaluations that need to be completed. 
All study withdrawals should be recorded by the Investigator in the appropriate screens of the e-
CRF and in the participant’s medical records. In the medical record, at least the date of the 
withdrawal and the reason should be documented. 
Withdrawal of consent for follow-up visits should be distinguished from withdrawal of consent 
for non-patient contact follow-up, eg, medical record checks. The site should document any case 
of withdrawal of consent. 
Participants who have withdrawn from the study cannot be rerandomized (treated) in the study. 
Their inclusion and treatment numbers must not be reused.  
8.3 
LOST TO FOLLOW UP 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site.  
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• 
The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant wishes to and/or should continue in 
the study. 
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• 
Before a participant is deemed lost to follow up, the investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, if 
necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record. 
• 
Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up.  
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9 
STUDY ASSESSMENTS AND PROCEDURES 
Protocol waivers or exemptions are not allowed. 
Immediate safety concerns should be discussed with the sponsor immediately upon occurrence or 
awareness to determine if the participant should continue or discontinue study treatment. 
Adherence to the study design requirements, including those specified in the SoA, is essential and 
required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential participants 
meet all eligibility criteria. The investigator will maintain a screening log to record details of all 
participants screened and to confirm eligibility or record reasons for screening failure, as 
applicable.  
Procedures conducted as part of the participant’s routine clinical management (eg, blood count) 
and obtained before signing of the ICF may be utilized for screening or baseline purposes 
provided the procedures met the protocol-specified criteria and were performed within the time 
frame defined in the SoA. 
The maximum amount of blood collected from each participant over the duration of the study, 
including any extra assessments that may be required, will not exceed 110 mL. Repeat or 
unscheduled samples may be taken for safety reasons or for technical issues with the samples. 
9.1 
EFFICACY ASSESSMENTS  
9.1.1 MEASUREMENT OF PARASITEMIA 
Blood sampling for parasitology can be done usually by means of finger prick except when the 
timing for parasitology assessments coincide with time for clinical laboratory tests, in which case 
blood films can be done using the venous blood collected for clinical laboratory analyses. Parasite 
density, for asexual parasite and for gametocyte counts, expressed as the number of parasites per 
microliter of blood, will be recorded separately throughout the study. 
Two qualified microscopists should independently read the stained thick and thin films. Parasite 
densities will be calculated by averaging the two counts. Blood smears with non-concordant 
results (differences between the two microscopists in species diagnosis, or differences in parasite 
density by >50%) will be re-examined by a third, independent microscopist: if discordance relates 
to parasite density, it will be calculated by averaging the two most concordant counts; if 
discordance relates to species diagnosis, it will be determined by the third microscopist. 
Blood samples or blood spots will be collected for qPCR genotyping analysis and for RT-qPCR 
gametocyte detection (see Section 9.1.1.4 and Section 9.1.1.5). 
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For full details of slide preparation, determination of parasitemia and quality control, refer to the 
study operational manual. 
9.1.1.1 Screening/Pre-dose Blood Films 
Three slides (two thick films and one thin film) collected at the same timepoint should be 
prepared using samples taken within 4 hours of dosing. Local thick and thin blood films 
performed at the site, before Informed Consent signature, according to local standard procedures 
and within 4 hours prior to dosing, can be used for screening/pre-dose parasitemia assessment, 
provided that a standard procedure is in place at site and blood films staining is performed 
according to Study Parasitology Procedures Manual. 
The parasite count from the first thick film will be used to calculate the screening parasitemia 
value. 
The second thick film slide will be used to calculate a more accurate pre-dose parasitemia count 
(asexual). 
The thin film slide is used for parasite speciation. Only patients with P. falciparum mono-
infection should be recruited in the study. 
9.1.1.2 Post-dose Blood Films 
Three slides (two thick films and one thin film) will be prepared at each planned time point (see 
SoA for detailed time schedule). The first thick film slide will be used to determine parasite 
counts. The second thick film slide should be kept as contingency. The thin film slide is used 
specifically for parasite speciation which should be recorded at each time point. 
Additional unscheduled films may be prepared to confirm parasite clearance as described below. 
9.1.1.3 Definition of Parasite Clearance (by Microscopy) 
A blood film will be considered 'negative' when the examination of 1000 white blood cells reveals 
no asexual parasites (see the study operational manual for more detail). Parasite clearance time is 
defined as the time of the first negative film, to be confirmed with a second negative film prepared 
within 6 to 12 hours of the first one. Parasite clearance will be concluded following confirmation 
of the second negative film.  
If parasites have not cleared by 72 hours after IMP administration and criteria for rescue 
medication are not met at 72h, blood films should continue to be taken according to site standard 
practice (or at minimum every 8 hours) until parasite clearance is shown or until criteria for rescue 
medication are met (see Section 7.7.1). 
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9.1.1.4 Quantitative PCR, parasite genotyping analysis 
Blood samples to measure parasitemia by qPCR will be taken according to SoA; qPCR analysis 
will be performed by the testing laboratory at all scheduled time points. 
Blood samplings for genotyping will be collected according to SoA and at the time-points when 
recrudescence or re-infection after initial parasite clearance was shown on the blood slide. Parasite 
genotyping analysis will be performed by the testing laboratory on previously collected blood spot 
sample only in case of a positive blood film after initial parasite clearance: one pre-dose sample 
and one sample at 18 or 24 hours post dosing. A further sample will be analyzed at the time point 
at which recrudescence/re-infection occurs. 
9.1.1.5 Gametocyte Detection (RT-qPCR) 
Blood samples for RT-qPCR gametocyte detection will be taken according to SoA. RT-qPCR 
analysis will be performed by the testing laboratory at all scheduled time points to detect 
submicroscopic gametocytemia and characterize gametocyte maturation stage using the 
expression of Pfs25 in mRNA. 
9.2 
ADVERSE EVENTS 
Adverse event of special interest 
An AESI) is an AE (serious or nonserious) of scientific and medical concern specific to the 
Sponsor’s product or program, for which ongoing monitoring and immediate notification by the 
Investigator to the Sponsor is required. Such events may require further investigation in order to 
characterize and understand them. Adverse events of special interest may be added, modified or 
removed during a study by protocol amendment. 
• 
Pregnancy of a female subject entered in a study as well as pregnancy occurring in a 
female partner of a male subject entered in a study with IMP/NIMP;  
- 
Pregnancy occurring in a female patient entered in the clinical trial or in a female 
partner of a male patient entered in the clinical trial. It will be qualified as an SAE only 
if it fulfills one of the seriousness criteria (see Appendix 4). 
- 
Follow-up of the pregnancy in a female participant or in a female partner of a male 
participant is mandatory until the outcome has been determined (see Appendix 5) 
• 
Symptomatic overdose (serious or nonserious) with IMP/noninvestigational medicinal 
product (NIMP) 
- 
An overdose (accidental or intentional) with the IMP/NIMP is an event suspected by 
the Investigator or spontaneously notified by the patient (not based on systematic pills 
count) and defined as at least twice the intended dose.  
Of note, asymptomatic overdose has to be reported as a standard AE. 
• 
Increase in alanine transaminase (ALT) ): ALT ≥3 ULN (if baseline ALT <ULN) or, 
ALT ≥2 times the baseline value (if baseline ALT ≥ULN) will be reported as AESI.  
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Cases of ALT >3 ULN will be monitored according to the procedures indicated in 
Appendix 7. 
Patients with abnormal ALT values at Day 28 will be followed up until ALT returns to 
normal values. A PK sample will be made at time of event for OZ439 and FQ 
(& SSR97213) concentration measurement. 
An ALT increase ≥3ULN is reportable as an SAE in any of the following situation: 
- 
Possible Hy’s law: ALT or AST >3x ULN and bilirubin >2x ULN (>35% direct 
bilirubin) in the absence of a serum alkaline phosphatase level >2x ULN. [If 
fractionation is unavailable, record presence of detectable urinary bilirubin on dipstick 
indicating direct bilirubin elevations and suggesting liver injury]) or 
- 
when ALT  >10 x ULN, 
- 
when associated with jaundice or, 
- 
when associated with coagulation disorder (prothrombin time <50%) or, 
- 
in presence of signs of hepatic encephalopathy. 
• 
Other project specific AESI: 
- 
QTcF ≥500 ms or QTcF prolongation > 60 ms from baseline 
In the event of QTcF interval ≥500 ms (automatic measurement) or a QTcF prolongation 
>60 ms (automatic measurement) from baseline, the patient should be placed under 
supervision in a specialized setting.  
Subsequent ECG monitoring of the patient should then be performed on a regular and 
clinically responsible basis until the QTc interval returns to their baseline QTcF value. 
In case of QTcF ≥500 ms (automatic measurement) or QTcF prolongation >60 ms from 
baseline, patient will have blood drawn for measurement of OZ439 and FQ (& SSR97213) 
concentration.  
The Investigator will report an AESI only if QTcF ≥500 ms or QTcF prolongation >60 ms 
from baseline is confirmed by central reading. 
The definitions of an AE or SAE can be found in Appendix 4. 
AE will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the 
participant's legally authorized representative).  
The investigator and any designees are responsible for detecting, documenting, and recording 
events that meet the definition of an AE or SAE and remain responsible for following up AEs that 
are serious, considered related to the study treatment or study procedures, or that caused the 
participant to discontinue the study (see Section 8).  
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9.2.1 Time period and frequency for collecting AE and SAE information  
All SAEs will be collected from the signing of the ICF until Day 28 at the time points specified in 
the SoA (Section 2). 
All AE will be collected from the signing of the ICF until Day 28 at the time points specified in 
the SoA (Section 2). 
All SAEs and AESIs will be recorded and reported to the sponsor or designee within 24 hours, as 
indicated in Appendix 4. The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available. 
Investigators are not obligated to actively seek AE or SAE in former study participants. However, 
if the investigator learns of any SAE, including a death, at any time after a participant has been 
discharged from the study, and he/she considers the event to be reasonably related to the study 
treatment or study participation, the investigator must promptly notify the sponsor. 
The method of recording, evaluating, and assessing causality of AE and SAE and the procedures 
for completing and transmitting SAE reports are provided in Appendix 4. 
9.2.2 Method of detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.  
9.2.3 Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, and non-serious AEs of special interest (as defined in 
Section 9.2), will be followed until resolution, stabilization, the event is otherwise explained, or 
the participant is lost to follow-up (as defined in Section 8.3). Further information on follow-up 
procedures is given in Appendix 4. 
9.2.4 Regulatory reporting requirements for SAEs 
• 
Prompt notification by the investigator to the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of 
a study treatment under clinical investigation are met.  
• 
The sponsor has a legal responsibility to notify both the local regulatory authority and 
other regulatory agencies about the safety of a study treatment under clinical investigation. 
The sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, Institutional Review Boards (IRB)/Independent 
Ethics Committees (IEC), and investigators. 
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• 
Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions (SUSAR) according to local regulatory requirements and sponsor policy and 
forwarded to investigators as necessary. 
• 
An investigator who receives an investigator safety report describing a SAE or other 
specific safety information (eg, summary or listing of SAEs) from the sponsor will review 
and then file it along with the IB and will notify the IRB/IEC, if appropriate according to 
local requirements. 
9.2.5 Cardiovascular and death events 
Cardiovascular and death events will be managed as generally described in Section 9.2. 
9.2.6 Disease-related events and/or disease-related outcomes not qualifying as AEs or 
SAEs 
Symptoms related to uncomplicated malaria are not to be considered as AEs or SAEs, except if 
they meet seriousness criteria. Severe malaria is to be considered as SAE. 
9.2.7 Pregnancy 
• 
If a pregnancy is reported, the investigator should inform the sponsor within 24 hours of 
learning of the pregnancy and should follow the procedures outlined in Appendix 5. 
• 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs. 
9.2.8 Guidelines for reporting product complaints 
Any defect in the IMP/NIMP must be reported as soon as possible by the Investigator to the 
monitoring team that will complete a product complaint form within required timelines. 
Appropriate information (eg, samples, labels or documents like pictures or photocopies) related to 
product identification and to the potential deficiencies may need to be gathered. The Investigator 
will assess whether or not the quality issue has to be reported together with an AE or SAE. 
9.3 
TREATMENT OF OVERDOSE 
The sponsor does not recommend specific treatment for an overdose (3, 16). The investigator will 
treat the symptoms of the overdose by current standard of care.  
In the event of an overdose, the investigator or delegate should: 
1. Contact the Medical Monitor immediately. 
2. Closely monitor the participant for any AE/SAE and laboratory abnormalities until IMP 
can no longer be detected systemically (at least 5 months). 
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3. Obtain a plasma sample for PK analysis within 1 day from the date of the last dose of 
study treatment if requested by the Medical Monitor (determined on a case-by-case basis). 
4. Document the quantity of the excess dose as well as the duration of the overdose in the e-
CRF. 
9.4 
SAFETY ASSESSMENTS  
Planned time points for all safety assessments are provided in the SoA. 
9.4.1 Physical examinations 
• 
Physical examination will include general appearance, head and eyes, ears, nose and 
throat, chest and lungs, cardiovascular, abdomen, neurological, lymphatic and 
musculoskeletal and any additional body system considered of relevance by the 
Investigator. Height and weight will also be measured and recorded. 
• 
A full assessment of uncomplicated P. falciparum malaria signs and symptoms will be 
made alongside the physical examination and will include fever, dizziness, headache, 
nausea, anorexia, vomiting, diarrhea, itching, urticaria, skin rash, abdominal pain, joint 
pain, muscle pain, palpitations, sleep problems, confusion, hearing problems, vision 
problems, and fatigue. 
• 
Investigators should pay special attention to clinical signs related to previous serious 
illnesses. 
• 
Any new finding or worsening of previous finding should be reported as a new AE. 
9.4.2 Vital signs 
• 
Axillary temperature, pulse rate, and blood pressure will be assessed. 
• 
Axillary temperature should be recorded in °C and to an accuracy of one decimal place. If 
the axillary method is not possible, an alternative route (tympanic, oral or rectal) may be 
used. The alternative route shall be recorded in the e-CRF. Within an individual patient the 
same method of temperature measurement (axillary, tympanic, oral or rectal) should be 
used throughout the entire study period.  
• 
Blood pressure and pulse measurements will be assessed with a completely automated 
device. Manual techniques will be used only if an automated device is not available. 
• 
Blood pressure and pulse measurements should be preceded by at least 5 minutes of rest in 
supine position for the participant in a quiet setting without distractions (eg, television, cell 
phones). 
• 
Vital signs (to be taken before blood collection) will consist of 1 pulse and 3 blood 
pressure measurements (3 consecutive blood pressure readings will be recorded at 
intervals of at least 1 minute). The average of the 3 blood pressure readings will be 
recorded on the e-CRF. 
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9.4.3 Electrocardiograms 
• 
Heart rate, QRS duration, PR interval, QT interval, ST deviation and T-wave morphology 
and also U-wave presence or absence will be determined using centralized readings of all 
ECGs.  
• 
The screening visit ECG will be read by the Investigator and the automatic QTcF 
calculation will serve as the reference for exclusion criterion E 18.  
• 
All ECG recordings (triplicate) will be centrally read by independent experts. 
• 
Refer to the study operational manual for more details.   
9.4.4 Clinical safety laboratory assessments 
• 
See Appendix 2 for the list of clinical laboratory tests to be performed and to the SoA for 
the timing and frequency.  
• 
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the e-CRF. The 
laboratory reports must be filed with the source documents. Clinically significant 
abnormal laboratory findings are those which are not associated with the underlying 
disease, unless judged by the investigator to be more severe than expected for the 
participant's condition. 
• 
All laboratory tests with values considered clinically significantly abnormal during 
participation in the study should be repeated until the values return to normal or baseline 
or are no longer considered clinically significant by the investigator or medical monitor. 
- 
If such values do not return to normal/baseline within a period of time judged 
reasonable by the investigator, the etiology should be identified and the sponsor 
notified. 
- 
All protocol-required laboratory assessments, as defined in Appendix 2, must be 
conducted in accordance with the local laboratory manual and the SoA.  
- 
If laboratory values from non-protocol specified laboratory assessments performed at 
the institution’s local laboratory require a change in participant management or are 
considered clinically significant by the investigator (eg, SAE or AE or dose 
modification), then the results must be recorded in the CRF.  
9.5 
PHARMACOKINETICS 
Whole blood samples will be collected for measurement of plasma concentrations of OZ439 and 
blood concentration 
 of FQ and SSR97213 as specified in the SoA. The 
list of PK samples is provided in Table 3. Instructions for the collection and handling of biological 
samples will be provided by the sponsor. The actual date and time (24-hour clock time) of each 
sample will be recorded. 
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Table 3 – Numbering of PK samples 
Timepoint 
FQ and SSR97213 in blood 
OZ439 in plasma 
Predose 
00 
P00 
1 h 
01 
P01 
2 h 
- 
P02 
4 h 
02 
P03 
6 h 
03 
P04 
8 h 
04 
- 
12 h 
05 
P05 
24 h 
06 
P06 
48 h 
- 
P07 
72 h 
07 
P08 
120 h 
- 
P09 
168 h 
08 
P10 
Day 14±1 
09 
P11 
Day 28±2 
10 
- 
Total number of samples 
11 
12 
 
A summary of handling procedures is provided in Table 4 and Table 5. Blood sample of at least 
1.2 mL (*) will be used to evaluate the PK of FQ and SSR97213 and the PK of OZ439. 
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Table 5 – Summary of handling procedure of PK plasma samples 
 
OZ439 in plasma 
Anticoagulant 
K3-EDTA 
Handling procedure 
see study operational manual specifications 
Blood volume 
At least 1.2 mL (*) 
Blood aliquot split 
2 
Blood storage conditions 
Frozen at -20°C 
Blood shipment conditions 
Dry ice 
 
Each sample for each analyte will be divided into 2 aliquots:  
• 
Aliquot #1 samples will be sent to the reference laboratory 
• 
Aliquot #2 samples will be stored at the investigator’s site until further instructions 
Plasma 
 remaining after determination of the above concentrations may be used for 
possible exploratory analysis of drug/metabolites. 
A summary of bioanalytical methods is provided in Table 6. 
Table 6 – Summary of PK bioanalytical methods 
 
OZ439 in plasma 
Analyte 
OZ439 
Matrix 
 
Plasma 
Analytical technique 
LC-MS/MS 
Lower limit of quantification 
1 ng/mL 
Assay volume 
50 µL 
Site of bioanalysis 
Swiss BioQuant AG 
Method reference 
SBQ-12026 
 
The PK parameters derived from the concentrations are described in Section 4. 
Genetic analyses will not be performed on these samples.  
Residual or leftover plasma or blood samples may be used for additional research purposes on 
malaria, after the patient will have consented to it. 
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9.6 
PHARMACODYNAMICS 
Pharmacodynamic parameters are not evaluated in this study. 
9.7 
GENETICS 
Human genetics are not evaluated in this study. 
9.8 
BIOMARKERS 
Biomarkers are not evaluated in this study. 
9.9 
MEDICAL RESOURCE UTILIZATION AND HEALTH ECONOMICS 
Health Economics/Medical Resource Utilization and Health Economics parameters are not 
evaluated in this study. 
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10 
STATISTICAL CONSIDERATIONS  
10.1 
SAMPLE SIZE DETERMINATION  
The strategy for selecting fixed FQ dose, baseline parasitemia, and sample size was composed of 
two parts: 
1. Estimated efficacy (Day 28 PCR corrected ACPR) of FQ 200, 400, 600 and 900 mg 
administrated in presence of OZ439 TPGS for different levels of baseline parasitemia 
2. Estimated power for various sample size of an OZ439 exposure-effect analysis, 
considering the fixed FQ dose, the 4 selected OZ439 dose levels (0, 300, 600, 1000 mg) 
and the selected baseline parasitemia 
Details of the method are provided in Appendix 8. 
Results estimated that 30 evaluable participants per treatment arm will yield a power around 90% 
to detect an OZ439 concentration effect relation (in a population of patient with a baseline 
parasitemia greater than 3000 parasites/µL, for 4 arms FQ 400 mg + OZ439 at 0, 300, 600, and 
1000 mg).  
Around 15 % of early dropout is anticipated, consequently approximately 35 participants are to be 
included in each arm (to get 30 evaluable participants/arm) resulting in approximately 140 
participants to be enrolled in the whole study.  
10.2 
POPULATIONS FOR ANALYSES 
For purposes of analysis, the following populations are defined (Table 7): 
Table 7 - Populations for analyses 
Population 
Description 
Screened participants  
All participants who sign the ICF and met the inclusion criteria 
Randomized participants (intent to treat 
[ITT]) 
All participants with a treatment kit number allocated and recorded in IRT database at 
Visit 2 (Day 0), and regardless of whether the treatment kit was used or not 
Evaluable (modified ITT [mITT]) 
All randomized participants with parasitologically confirmed malaria at baseline, who 
received at least the single administration of OZ439/FQ 400 mg and who have 
parasitemia data post-randomization. Participants will be analyzed according to the 
treatment arm allocated by randomization 
Safety 
All randomized participants who take at least 1 dose or part of a dose of the single 
administration OZ439 & FQ 400 mg. Participants will be analyzed according to the 
treatment they actually received 
PK 
All participants included in the Safety population with at least one evaluable blood 
sample for PK post IMP administration and with adequate documentation of date of 
dosing and date of sampling 
PK/PD 
All participants included in both the mITT population and the PK population 
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10.3 
STATISTICAL ANALYSES 
The statistical analysis plan (SAP) will be developed and finalized before database lock and will 
describe the participant populations to be included in the analyses, and procedures for accounting 
for missing, unused, and spurious data. This section is a summary of the planned statistical 
analyses of the primary and secondary endpoints. 
10.3.1 Efficacy analyses 
All efficacy analyses will be performed on the mITT Population. The efficacy analyses are 
summarized in Table 8. 
Table 8 - Efficacy analyses 
Endpoint 
Statistical Analysis Methods 
For primary objective: 
• 
Day 28 PCR-corrected 
ACPR 
 
• 
The exposure-response association of single-dose OZ439/FQ for PCR-corrected 
ACPR at Day 28 will demonstrate how the probability of a response in PCR-
corrected ACPR at Day 28 increases with exposure (AUC) to OZ439/FQ. Logistic 
regression with p: probability of PCR-corrected ACPR at Day 28 and OZ439 AUC 
and FQ AUC0-Day28 (SSR97213 AUC0-Day28 will be considered also) and baseline 
parasitemia as covariates will be fitted.  
• 
Results of logistic regressions of PCR-corrected ACPR on exposure will be 
provided in a summary table including odds ratio estimates, the corresponding 95% 
Wald CIs and p-value. 
• 
Frequency table for Day 28 PCR-corrected ACPR, i.e. proportion, percentage and 
exact binomial 95% CIs (two-sided by using Clopper-Pearson method for 
calculating binomial CIs) by treatment arm, will also be provided. 
For secondary objectives: 
• 
Day 28 PCR-corrected 
ACPR 
 
• 
The dose-response exposure-response association of single-dose OZ439/FQ for 
PCR-corrected ACPR at Day 28 will demonstrate how the probability of a response 
in PCR-corrected ACPR at Day 28 increases with increasing dose of OZ439/FQ 
thanks to a logistic regression. Results of logistic regressions of PCR-corrected 
ACPR on dose will be provided in a summary table including odds ratio estimates, 
the corresponding 95% Wald CIs, and p-value. 
• 
Parasitemia at baseline 
then every 6 h during 
the first 36 h then at 
48 h and every 24 h 
until Day 7  
• 
Descriptive statistics (number of observations [n], mean, geometric mean, standard 
deviation [SD], median, first quartile [Q1], third quartile [Q3], minimum, and 
maximum) for parasitemia data (number of parasites/µL) (raw data and absolute 
change from baseline) will be displayed at each post-baseline assessment. Time 
profile plots (Mean ± standard error of the mean) of parasitemia will be provided for 
each treatment arm, one curve per arm. 
• 
Day 28 crude ACPR 
• 
Same analysis using Clopper-Pearson method as for PCR-corrected ACPR will be 
done on crude ACPR at Day 28. The exposure-response (respectively dose-
response) association of single-dose OZ439/FQ for crude ACPR will also be 
evaluated. 
A generalized MCP-Mod approach will be used with PCR-corrected and crude 
ACPR at Day 28. Both linear and log model will be fitted. Then the dose response 
signal will be tested via contrasts based on dose-response shape. Selection of the 
model needs investigations which will be detailed in the SAP. 
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• 
Observed PRR at 24 h, 
48 h, and 72 h 
• 
Descriptive statistics (n, mean, geometric mean, standard deviation, median, Q1, 
Q3, minimum, and maximum) by treatment arm and time of measurement. 
• 
Parasite clearance rate 
• 
Parasite clearance estimator established by WWARN (1) will be used to identify the 
lag phase, clean the data for outliers, and determine the best model (linear, 
quadratic, cuboidal) to fit the log-transformed parasite data and afterward calculate 
the following estimate: the parasite clearance rate. Descriptive statistics (median, 
first Q1, Q3, minimum, and maximum) will be provided for each treatment arm. 
• 
Time 
- 
to parasite 
clearance 
- 
to 99% parasite 
reduction 
- 
to recrudescence 
or re-infection 
- 
elapsed below 
LOQ of 
parasitemia 
• 
Kaplan-Meier estimators.  
• 
For each variable, an overall overview including number of events (frequency and 
%), 25%, median and 75% quantile with 95% CI (expressed in weeks), cumulative 
incidence of events with 95% CI will be provided in a summary table for all 
participants.  
• 
Survival curves will be plotted by representing each treatment arm for all 
participants. 
• 
Cox model will be used for time to event endpoints with OZ439 doses and 
parasitemia at baseline as covariates, potential interaction will be explored. 
Exploratory 
Will be described in the statistical analysis plan finalized before database lock 
10.3.1.1  Definition of ACPR, recrudescence, and re-infection 
ACPR is defined based on WHO recommendations (2) as follows: 
ACPR 
• 
absence of parasitemia (blood films) on Day 28, irrespective of axillary temperature, 
without previously meeting any of the criteria of early treatment failure or late clinical 
failure or late parasitological failure (see definitions in Section 7.7.1) or having received a 
rescue treatment for malaria in the conditions defined in Section 7.7.1. 
Recrudescence 
• 
appearance of asexual parasites after clearance of initial infection with a genotype 
identical to that of parasites present at baseline. 
Re-infection 
• 
appearance of asexual parasites after clearance of initial infection with a genotype that 
differs from that of parasites present at baseline. Confirmed new infection will not be 
regarded as treatment failure or recrudescence. 
Crude ACPR 
• 
Crude ACPR applies to both recrudescence of the parasite clone responsible for baseline 
infection and re-infection by a different clone. 
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PCR-corrected ACPR 
• 
the PCR-corrected ACPR applies only to recrudescence (re-emergence of the original 
clone of parasite that is present at baseline). Recrudescence is distinguished from re-
infection by genotyping the parasite clone. 
10.3.2 Safety analyses 
All safety analyses will be performed on the Safety Population (see Table 7). The safety analyses 
are summarized in Table 9. 
Table 9 - Safety analyses 
Endpoint 
Statistical Analysis Methods 
For secondary objectives 
 
The summary of safety results will be presented by treatment arm thanks to descriptive 
statistics (summary tables, graphics). No formal inferential testing will be performed. 
• 
AEs 
• 
Frequency tables of TEAEs and SAEs by treatment arm during the on-treatment 
phase 
• 
Summary tables of participant count (%) for each AESI by treatment arm 
• 
Summary tables of deaths 
• 
incidence of liver-related AEs summarized by treatment arm 
• 
Clinical laboratory 
tests 
• 
Counts of participants with potentially clinically significant abnormalities (PCSAs) at 
any time during the on-treatment phase will be summarized by treatment arm in 
summary tables showing shifts from normal and abnormal baselines to postbaseline 
abnormalities.  
• 
LFT 
• 
raw data and changes from baseline summarized in descriptive statistics, by 
treatment arm and visit for all participants 
• 
time profile plots (mean+/- SD) on raw data and change from baseline  
• 
proportion of participants with PCSA values at any post baseline visit by baseline 
status will be displayed by treatment arm 
• 
graph of distribution (e-Dish plot) of peak values of ALT versus peak values of total 
bilirubin  
• 
normalization (to ≤1 x ULN or return to baseline) of elevated liver function tests 
summarized by categories of elevation 
• 
Vital signs 
• 
raw parameter value and change from baseline 
• 
Counts of participants with post-baseline PCSAs in summary tables by treatment arm 
• 
ECG 
• 
Heart rate, PR-, QRS-, and QT-intervals, corrected QTc (Fridericia) will be analyzed 
as raw parameter value and change from baseline, as well as percent change from 
baseline for selected parameters 
• 
Counts of participants with post-baseline PCSAs in summary tables by treatment arm. 
• 
A summary of ECG morphological assessments (for all high level types of comments) 
by treatment arm 
• 
Summary plots (mean+/-SD) on raw data and changes from baseline, as well as 
percent change from baseline for selected parameters  
• 
Physical examination 
• 
Summary tables of participant count (%) for each physical examination (general 
appearance, head and eyes, ears, nose and throat, chest and lungs, cardiovascular, 
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abdomen, neurological, lymphatic and musculoskeletal and any additional body 
system considered of relevance by the Investigator) by treatment arm. 
• 
Clinical signs and 
symptoms related to 
uncomplicated P. 
falciparum malaria 
• 
Summary tables of participant count (%) for each of the clinical signs and symptoms 
(Fever, Dizziness, Headache, Nausea, Anorexia, Vomiting, Diarrhea, Itching, 
Urticaria, Skin Rash, Abdominal Pain, Joint Pain, Muscle Pain, Palpitations, Sleep 
Problems, Confusion, Hearing Problems, Vision Problems, and Fatigue) by primary 
system organ class, high level term and treatment arm. 
10.3.2.1   Observation period 
For all safety data (see Section 9.2 and Section 9.4 for details), the observation period will be 
divided into three phases: 
• 
The pre-treatment phase defined as the time between the participant gives informed 
consent and the start time of first IMP administration (excluded) 
• 
The on-treatment phase defined as the start time of first dose of IMP administration 
(included) up to Day 28 visit (included) 
• 
The post-treatment phase will be defined as the time after the Day 28 visit (excluded) 
10.3.2.2    Baseline 
The baseline value is defined as the last available value before first IMP at Visit 1 (screening) for 
laboratory and vital signs and at Visit 2 (Day 0 before IMP administration) for ECG parameters. 
10.3.2.3  Adverse events 
AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA, last 
version available before database lock). 
They will be classified into predefined standard categories according to chronological criteria: 
• 
Pre-treatment AEs are defined as AEs that occurred, worsened (according to Investigator 
opinion) or became serious during the pre-treatment phase 
• 
TEAEs are defined as AEs that occurred or worsened or became serious during the on-
treatment phase 
• 
Post-treatment AEs are defined as AEs that occurred worsened or became serious during 
the post-treatment phase. 
10.3.2.4  Potentially clinically significant abnormalities 
The following definitions will be applied to laboratory parameters, vital signs, and ECG: 
• 
The PCSA values are defined as abnormal values considered medically important by the 
Sponsor according to predefined criteria/thresholds based on literature review and defined 
by the Sponsor for clinical laboratory tests, vital signs and ECG 
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• 
PCSA criteria will determine which participants had at least 1 PCSA during the on-
treatment phase, taking into account all evaluations performed during the on-treatment 
phase, including unscheduled or repeated evaluations. The number of all such participants 
will be the numerator for the PCSA percentage. 
10.3.2.5  Drug-induced liver injury and QT prolongation 
To prevent missing any event related to the AESI defined for the study (see Section 9.2), the 
selection of preferred terms will be based on standardized MedDRA queries (SMQs):  
• 
Hepatic disorder (code 20000005, level 1, active) for potential DILI events  
• 
Torsade de pointes/QT prolongation (code 20000001, level 1, active) for potential cardiac 
events  
Time to liver-related treatment discontinuation and time to liver death may also be provided based 
on hepatic disorder SMQ. 
10.3.3 PK analyses 
All PK analyses will be performed on the PK Population (see Table 7). The PK analyses are 
summarized in Table 10. 
Table 10 - PK analyses 
Endpoint 
Statistical Analysis Methods 
For secondary objectives 
 
• 
Concentrations 
• 
Descriptive statistics by treatment arm and by time point 
• 
PK parameters 
• 
Descriptive statistics (such as arithmetic mean, geometric mean, median, SD, SEM, 
coefficient of variation, minimum, and maximum) for each treatment arm 
10.3.3.1  Pharmacokinetic parameters 
Pharmacokinetic parameters are listed in Section 4. 
The PK parameters will be estimated through Bayesian analysis using previously developed 
population PK models.  
The Bayesian PK analyses for OZ439 and for Ferroquine and its metabolite will be reported 
separately from the main clinical report in 2 different reports. 
10.3.4 Other analyses  
Exploratory analyses (such as PK/QTc analyses) will be described in the SAP finalized before 
database lock. The PK/QTc analysis will be presented in the clinical report; the parasitemia 
evaluated by qPCR (pharmacodynamics) and the exploratory analysis between parasitemia 
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(measured by qPCR) and concentration of OZ439/FQ analyses will be presented separately from 
the main clinical study report.  
10.3.5 Interim analyses  
No interim analysis is planned (16). 
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11 
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14. Leang R, Barette A, Bouth DM, Menard D, Abdur R, Duong S, et al. Efficacy of dihydro-
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of artefenomel (OZ439) and piperaquine to investigate single˜dose treatment for 
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18. World Food Program and Centers for Diseases Control and Prevention. A manual: measuring 
and interpreting malnutrition and mortality. Nov 2005. 
http://www.unhcr.org/45f6abc92.pdf19.Held J, Supan C, Salazar CLO, Tinto H, Bonkian LN, 
Nahum A, et al. Ferroquine and artesunate in African adults and children with Plasmodium 
falciparum malaria: a phase 2, multicenter, randomized, double-blind, dose-ranging, non-
inferiority study. Lancet Infect Dis. 2015 Dec 3;15(12):1409-19.  
 
 
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12 
APPENDICES 
 
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Appendix 1 
Abbreviations 
 
°C: 
degree Celsius 
ACPR: 
adequate clinical and parasitological response 
ACT: 
artemisinin-based combined therapy 
AE: 
adverse event 
AESI: 
adverse event of special interest 
AF: 
atrial fibrillation 
ALT: 
alanine transferase 
AST: 
aspartate transferase 
AUC: 
area under the concentration time curve up to infinity 
AUC0-Day28: 
area under the concentration time curve from T0 to Day 28 
C168h: 
concentraton at 168 h post dose 
CI: 
confidence interval 
Cmax: 
maximum concentration 
CONSORT: 
Consolidated Standards of Reporting Trials 
CYP: 
cytochrome P450 
ECG: 
electrocardiogram 
e-CRF: 
electronic case report form 
EDTA: 
ethylenediaminetetraacetic acid 
FDA: 
Food and Drug Administration 
FDC: 
fixed dose combination 
FQ: 
ferroquine 
HAV IgM: 
hepatitis A immunoglobulin M 
HBsAg: 
hepatitis B surface antigen 
HCG: 
human chorionic gonadotropin 
HCV Ab: 
hepatitis C virus antibody 
HCV RNA: 
hepatitis C virus ribonucleic acid 
IB: 
investigator's brochure 
ICF: 
informed consent form 
IEC: 
Independent Ethics Committee 
IMP: 
investigational medicinal product 
IND: 
investigational new drug 
INN: 
international nonproprietary name 
IRB: 
Institutional Review Board 
IRT: 
interactive response technology 
ITT: 
intent to treat 
LAR: 
legally acceptable representative 
LC-MS/MS: 
liquid chromatography tandem mass spectroscopy 
LFT: 
liver function tests 
LOQ: 
limit of quantification 
M&S: 
modeling and simulations 
MCP-Mod: 
multiple comparisons procedures-modeling 
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MedDRA: 
Medical Dictionary for Regulatory Activities 
mITT: 
modified intent to treat 
MMV: 
Medicines for Malaria Venture 
n: 
number of observations 
NDA: 
new drug administration 
NIMP: 
noninvestigational medicinal product 
P. falciparum: 
Plasmodium falciparum 
PCR: 
polymerase chain reaction 
PCSA: 
potentially clinically significant abnormalities 
P-gp: 
P-glycoprotein 
PK: 
pharmacokinetic(s) 
PQP: 
piperaquine phosphate 
PRR: 
parasite reduction rate 
Q1: 
first quartile 
Q3: 
third quartile 
qPCR: 
quantitative polymerase chain reaction 
QTcF: 
QT interval corrected using Fridericia formula 
RT-qPCR: 
quantitative reverse transcription polymerase chain reaction 
SAE: 
serious adverse event 
SAP: 
statisctical analysis plan 
SD: 
standard deviation 
SMQ: 
standardized MedDRA query 
SoA: 
schedule of activities 
SUSAR: 
suspected unexpected serious adverse reaction 
t1/2: 
terminal half-life 
TEAE: 
treatment emergent adverse event 
tmax: 
time to reach the maximal concentration 
TPGS: 
alpha tocopherol polyethylene glycol 1000 succinate 
ULN: 
upper limit of normal range 
USFDA: 
United States Food and Drug Administration 
WHO: 
World Health Organization 
WOCBP: 
woman of childbearing potential 
WWARN: 
worldwide antimalarial resistance network 
 
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Appendix 2 
Clinical laboratory tests 
• 
The tests detailed in Table 11 will be performed by the local laboratory  
• 
Protocol-specific requirements for inclusion or exclusion of participants are detailed in 
Section 6.1 and Section 6.2 of the protocol. 
• 
Additional tests may be performed at any time during the study as determined necessary 
by the investigator or required by local regulations. 
Table 11 - Protocol-required safety laboratory assessments 
Laboratory 
assessments 
 
Parameters 
Hematology 
Platelet count  
RBC count 
Hemoglobin 
Hematocrit 
Reticulocytesa 
 
WBC Count with Differential: 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
Clinical chemistryb 
Urea 
Potassium 
Aspartate 
aminotransferase (AST) 
Total bilirubin 
 
Lactate 
dehydrogenasea 
Sodium 
Alanine 
aminotransferase (ALT) 
Direct bilirubin if total 
bilirubin ≥ULNa 
 
Creatinine 
Magnesium 
(screening) 
Alkaline phosphatase 
Albumin 
 
Creatinine clearancec 
Calcium (screening) 
 
Haptoglobina 
 
Creatine kinase 
 
 
 
 
Glucose (non-fasting) 
 
 
 
Routine urinalysis 
• 
Specific gravity 
• 
pH, glucose, protein, blood, ketones, bilirubin, leukocyte esterase by dipstick 
• 
Microscopic examination (if blood or protein is abnormal) 
• 
Pregnancy test (urine β-HCG)d for WOCBP 
Other screening tests 
• 
Hepatitis serology: HAV IgM, HBsAg, HCV Ab, and/or HCV RNA (if known) 
• 
The results of each test must be entered into the e-CRF. 
NOTES : 
a Test not needed for screening but must be available during the study to monitor the participant’s health status. The test must be either 
available locally or in a national reference laboratory with which the site has an agreement for performing the test. 
b Details of liver chemistry criteria and required actions and follow-up assessments are given in Section 9.2 and Appendix 7. . 
c For participants >18 years old, the creatinine clearance (CrCl) will be calculated from Cockroft and Gault formula: CrCl (mL/min) = 1.23 
(for male) or 1.04 (for female) x weight (kg) x (140 - Age) / serum creatinine (µmol/L) with age in years. For participants ≤18 years old, the 
GFR Bedside Schwartz Formula should be used: eGFR (mL/min/1.73 m²) = 0.413 x height (cm) / serum creatinine (mg/dL) 
d Local urine testing will be standard for the protocol unless serum testing is required by local regulation or IRB/IEC. 
Investigators must document their review of each laboratory safety report. 
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Appendix 3 
Study governance considerations 
Regulatory and ethical considerations 
• 
This study will be conducted in accordance with the protocol and with the following: 
- 
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
- 
Applicable ICH Good Clinical Practice (GCP) Guidelines 
- 
Applicable laws and regulations 
• 
The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant 
documents (eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC before the study is initiated.  
• 
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.  
• 
The investigator will be responsible for the following: 
- 
Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC 
- 
Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures 
- 
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 536/2014 
for clinical studies (if applicable), and all other applicable local regulations 
Financial disclosure 
Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the course of the study and for 
1 year after completion of the study. 
Informed consent process 
• 
The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions regarding 
the study.  
• 
Participants must be informed that their participation is voluntary. Participants or their 
legally authorized representative will be required to sign a statement of informed consent 
that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, Health 
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Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, 
and the IRB/IEC or study center.  
• 
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICF. 
• 
Participants must be re-consented to the most current version of the ICF(s) during their 
participation in the study.  
• 
A copy of the ICF(s) must be provided to the participant or the participant’s legally 
authorized representative.  
• 
Participants who are rescreened are required to sign a new ICF. 
Data protection 
• 
Participants will be assigned a unique identifier by the sponsor. Any participant records or 
datasets that are transferred to the sponsor will contain the identifier only; participant 
names or any information which would make the participant identifiable will not be 
transferred.  
• 
The participant must be informed that his/her personal study-related data will be used by 
the sponsor in accordance with local data protection law. The level of disclosure must also 
be explained to the participant.  
• 
The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory authorities. 
Safety Management Team 
A Safety Management Team (SMT), cross-functional team led by the Global Safety Officer, will 
be set-up to ensure comprehensive characterization of the safety profile of IMP and appropriate 
risk mitigation.  
The SMT may identify and invite ad-hoc members or contributors (external and/or internal) as 
required providing necessary expertise based on the safety medical concepts/issues to be 
reviewed. 
Publication policy 
• 
The results of this study may be published or presented at scientific meetings. If this is 
foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor 
before submission. This allows the sponsor to protect proprietary information and to 
provide comments.  
• 
The sponsor will comply with the requirements for publication of study results. In 
accordance with standard editorial and ethical practice, the sponsor will generally support 
publication of multicenter studies only in their entirety and not as individual site data. In 
this case, a coordinating investigator will be designated by mutual agreement. 
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• 
Authorship will be determined by mutual agreement and in line with International 
Committee of Medical Journal Editors authorship requirements. 
Dissemination of clinical study data 
Sanofi shares information about clinical trials and results on publically accessible websites, based 
on company commitments, international and local legal and regulatory requirements, and other 
clinical trial disclosure commitments established by pharmaceutical industry associations.  These 
websites include clinicaltrials.gov, EU clinicaltrialregister (eu.ctr), and sanofi.com, as well as 
some national registries. 
In addition, results from clinical trials in patients are required to be submitted to peer-reviewed 
journals following internal company review for accuracy, fair balance and intellectual property. 
For those journals that request sharing of the analyzable data sets that are reported in the 
publication, interested researchers are directed to submit their request to 
clinicalstudydatarequest.com. 
Individual participant data and supporting clinical documents are available for request at 
clinicalstudydatarequest.com. While making information available we continue to protect the 
privacy of participants in our clinical trials. Details on data sharing criteria and process for 
requesting access can be found at this web address: clinicalstudydatarequest.com.  
Data quality assurance 
• 
All participant data relating to the study will be recorded on printed or e-CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator 
is responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the e-CRF.  
• 
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the e-CRF.  
• 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.  
• 
The sponsor or designee is responsible for the data management of this study including 
quality checking of the data.  
• 
Study monitors will perform ongoing source data verification to confirm that data entered 
into the e-CRF by authorized site personnel are accurate, complete, and verifiable from 
source documents; that the safety and rights of participants are being protected; and that 
the study is being conducted in accordance with the currently approved protocol and any 
other study agreements, ICH GCP, and all applicable regulatory requirements.  
• 
Records and documents, including signed ICFs, pertaining to the conduct of this study 
must be retained by the investigator for 15 years after study completion unless local 
regulations or institutional policies require a longer retention period. No records may be 
destroyed during the retention period without the written approval of the sponsor. No 
records may be transferred to another location or party without written notification to the 
sponsor.  
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Source documents 
• 
Source documents provide evidence for the existence of the participant and substantiate 
the integrity of the data collected. Source documents are filed at the investigator’s site. 
• 
Data entered in the e-CRF that are transcribed from source documents must be consistent 
with the source documents or the discrepancies must be explained. The investigator may 
need to request previous medical records or transfer records, depending on the study. Also, 
current medical records must be available. 
• 
Source data is all information in original records and certified copies of original records of 
clinical findings, observations, or other activities in a clinical study necessary for the 
reconstruction and evaluation of the study. Source data are contained in source documents 
(original records or certified copies). 
Study and site closure 
The sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are not 
limited to: 
• 
Failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or 
local health authorities, the sponsor's procedures, or GCP guidelines 
• 
Inadequate recruitment of participants by the investigator 
• 
Discontinuation of further study treatment development 
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Appendix 4 
Adverse events: definitions and procedures for recording, 
evaluating, follow-up, and reporting 
DEFINITION OF AE 
AE definition 
• 
An AE is any untoward medical occurrence in a patient or clinical study participant, 
temporally associated with the use of study treatment, whether or not considered related to 
the study treatment. 
• 
NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study treatment. 
Events meeting the AE definition 
• 
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the medical 
and scientific judgment of the investigator (ie, not related to progression of underlying 
disease). 
• 
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• 
New conditions detected or diagnosed after study treatment administration even though it 
may have been present before the start of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study treatment 
or a concomitant medication. 
• 
"Lack of efficacy" or "failure of expected pharmacological action" per se will not be 
reported as an AE or SAE. Such instances will be captured in the efficacy assessments. 
However, the signs, symptoms, and/or clinical sequelae resulting from lack of efficacy 
will be reported as AE or SAE if they fulfil the definition of an AE or SAE.  
Events NOT meeting the AE definition 
• 
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition. 
• 
The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant’s 
condition. 
• 
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to 
the procedure is the AE. 
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• 
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• 
Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen 
DEFINITION OF SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met (eg, hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
A SAE is defined as any untoward medical occurrence that, at any dose: 
a) Results in death 
b) Is life-threatening 
The term 'life-threatening' in the definition of 'serious' 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, which 
hypothetically might have caused death, if it were more severe. 
c) Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from 
baseline is not considered an AE. 
d) Results in persistent disability/incapacity 
- 
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
- 
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption. 
e) Is a congenital anomaly/birth defect 
f) Other situations: 
- 
Medical or scientific judgment should be exercised in deciding whether SAE reporting 
is appropriate in other situations such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize 
the participant or may require medical or surgical intervention to prevent one of the 
other outcomes listed in the above definition. These events should usually be 
considered serious. 
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- 
Examples of such events include invasive or malignant cancers, intensive treatment in 
an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug dependency 
or drug abuse. 
RECORDING AND FOLLOW-UP OF AE AND/OR SAE 
AE and SAE recording 
• 
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostics reports) 
related to the event. 
• 
The investigator will then record all relevant AE/SAE information in the e-CRF. 
• 
It is not acceptable for the investigator to send photocopies of the participant’s medical 
records in lieu of completion of the AE/SAE e-CRF page. 
• 
There may be instances when copies of medical records for certain cases are requested by 
the monitoring team. In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before 
submission to the monitoring team. 
• 
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE/SAE. 
Assessment of intensity 
The investigator will make an assessment of intensity for each AE and SAE reported during the 
study and assign it to 1 of the following categories: 
• 
Mild: An event that is easily tolerated by the participant, causing minimal discomfort and 
not interfering with everyday activities. 
• 
Moderate: An event that causes sufficiently discomfort and interferes with normal 
everyday activities. 
• 
Severe: An event that prevents normal everyday activities. An AE that is assessed as 
severe should not be confused with a SAE. Severe is a category utilized for rating the 
intensity of an event; and both AEs and SAEs can be assessed as severe. 
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes as described 
in the definition of an SAE, NOT when it is rated as severe. 
Assessment of causality 
• 
The investigator is obligated to assess the relationship between study treatment and each 
occurrence of each AE/SAE. 
• 
A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
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• 
The investigator will use clinical judgment to determine the relationship. 
• 
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study treatment administration 
will be considered and investigated. 
• 
The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment. 
• 
For each AE/SAE, the investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality. 
• 
There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the monitoring team . However, it is very 
important that the investigator always make an assessment of causality for every 
event before the initial transmission of the SAE data to the monitoring team. 
• 
The investigator may change his/her opinion of causality in light of follow-up information 
and send a SAE follow-up report with the updated causality assessment. 
• 
The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
Follow-up of AEs and SAEs 
• 
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the monitoring 
team  to elucidate the nature and/or causality of the AE or SAE as fully as possible. This 
may include additional laboratory tests or investigations, histopathological examinations, 
or consultation with other health care professionals. 
• 
If a participant dies during participation in the study or during a recognized follow-up 
period, the investigator will provide the monitoring team  with a copy of any post-mortem 
findings including histopathology. 
• 
New or updated information will be recorded in the originally completed e-CRF. 
• 
The investigator will submit any updated SAE data to the sponsor within 24 hours of 
receipt of the information. 
REPORTING OF SAES 
SAE reporting to the monitoring team via an electronic data collection tool 
• 
The primary mechanism for reporting an SAE to the monitoring team will be the 
electronic data collection tool. 
• 
If the electronic system is unavailable for more than 24 hours, then the site will use the 
paper SAE data collection tool (see next section). 
• 
The site will enter the SAE data into the electronic system as soon as it becomes available. 
• 
After the study is completed at a given site, the electronic data collection tool will be taken 
off-line to prevent the entry of new data or changes to existing data. 
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• 
If a site receives a report of a new SAE from a study participant or receives updated data 
on a previously reported SAE after the electronic data collection tool has been taken off-
line, then the site can report this information on a paper SAE form (see next section) or to 
the monitoring team by telephone. 
• 
Contacts for SAE reporting can be found in the clinical trial protocol. 
SAE reporting to the monitoring team via paper CRF 
• 
Facsimile transmission of the SAE paper CRF is the preferred method to transmit this 
information to the monitoring team. 
• 
In rare circumstances and in the absence of facsimile equipment, notification by telephone 
is acceptable with a copy of the SAE data collection tool sent by overnight mail or courier 
service. 
• 
Initial notification via telephone does not replace the need for the investigator to complete 
and sign the SAE CRF pages within the designated reporting time frames. 
• 
Contacts for SAE reporting can be found in the clinical trial protocol. 
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Appendix 5 
Contraceptive guidance and collection of pregnancy Information 
DEFINITIONS 
Woman of childbearing potential (WOCBP) 
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile (see below). 
Women in the following categories are not considered WOCBP 
1. Premenarchal 
2. Premenopausal female with 1 of the following: 
- 
Documented hysterectomy 
- 
Documented bilateral salpingectomy 
- 
Documented bilateral oophorectomy 
Note:  Documentation can come from the site personnel’s: review of the participant’s 
medical records, medical examination, or medical history interview. 
3. Postmenopausal female 
- 
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal 
range may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormonal replacement therapy (HRT). However, in the absence of 
12 months of amenorrhea, a single FSH measurement is insufficient.  
- 
Females on HRT and whose menopausal status is in doubt will be required to use one 
of the non-hormonal highly effective contraception methods if they wish to continue 
their HRT during the study. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment. 
CONTRACEPTION GUIDANCE 
Male participants 
• 
Male participants with female partners of childbearing potential are eligible to participate 
if they agree to ONE of the following for 3 months after the last dose of study treatment:  
- 
Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle 
(abstinent on a long term and persistent basis) and agree to remain abstinent 
- 
Agree to use a male condom plus partner use of a contraceptive method with a failure 
rate of <1% per year as described in Table 12 when having penile-vaginal intercourse 
with a woman of childbearing potential who is not currently pregnant 
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• 
In addition male participants must refrain from donating sperm for the duration of the 
study and for 3 months after the last dose of study treatment 
• 
Male participants with a pregnant or breastfeeding partner must agree to remain abstinent 
from penile-vaginal intercourse or use a male condom during each episode of penile 
penetration for 3 months after the last dose of study treatment  
Female participants 
Female participants of childbearing potential are eligible to participate if they agree to use a 
highly effective method of contraception consistently and correctly as described in Table 12. 
Table 12 - Highly effective contraceptive methods 
Highly effective contraceptive methods that are user dependenta 
Failure rate of <1% per year when used consistently and correctly. 
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulationb  
• 
Oral  
• 
Intravaginal  
• 
Transdermal 
Progestogen only hormonal contraception associated with inhibition of ovulationb 
• 
Oral  
• 
Injectable 
Highly effective methods that are user independenta 
Implantable progestogen only hormonal contraception associated with inhibition of ovulationb 
• 
Intrauterine device (IUD) 
• 
Intrauterine hormone-releasing system (IUS) 
Bilateral tubal occlusion 
Vasectomized partner  
A vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the 
WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be 
used. 
Sexual abstinence  
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the 
entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to 
the duration of the study and the preferred and usual lifestyle of the participant. 
NOTES:  
a Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with local regulations 
regarding the use of contraceptive methods for participants participating in clinical studies.  
b Hormonal contraception may be susceptible to interaction with the study treatment, which may reduce the efficacy of the contraceptive 
method. In this case, two highly effective methods of contraception should be utilized during the treatment period and for at least 3 months 
after the last dose of study treatment 
 
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PREGNANCY TESTING 
• 
WOCBP should only be included after a confirmed menstrual period and a negative highly 
sensitive urine pregnancy test. 
• 
Additional pregnancy testing will be performed on Day 28 and as required locally. 
• 
Pregnancy testing will be performed whenever a menstrual cycle is missed or when 
pregnancy is otherwise suspected  
• 
Urinary pregnancy testing will be performed locally 
COLLECTION OF PREGNANCY INFORMATION  
Male participants with partners who become pregnant  
• 
The investigator will attempt to collect pregnancy information on any male participant’s 
female partner who becomes pregnant while the male participant is in this study. This 
applies only to male participants who receive IMP. 
• 
After obtaining the necessary signed informed consent from the pregnant female partner 
directly, the investigator will record pregnancy information on the appropriate form and 
submit it to the sponsor within 24 hours of learning of the partner’s pregnancy. The female 
partner will also be followed to determine the outcome of the pregnancy. Information on 
the status of the mother and child will be forwarded to the sponsor. Generally, the follow-
up will be no longer than 6 to 8 weeks following the estimated delivery date. Any 
termination of the pregnancy will be reported regardless of fetal status (presence or 
absence of anomalies) or indication for the procedure.  
Female Participants who become pregnant  
• 
The investigator will collect pregnancy information on any female participant who 
becomes pregnant while participating in this study. Information will be recorded on the 
appropriate form and submitted to the sponsor within 24 hours of learning of a 
participant's pregnancy. The participant will be followed to determine the outcome of the 
pregnancy. The investigator will collect follow-up information on the participant and the 
neonate and the information will be forwarded to the sponsor. Generally, follow-up will 
not be required for longer than 6 to 8 weeks beyond the estimated delivery date. Any 
termination of pregnancy will be reported, regardless of fetal status (presence or absence 
of anomalies) or indication for the procedure. 
• 
Any pregnancy complication or elective termination of a pregnancy will be reported as an 
AE or SAE. A spontaneous abortion is always considered to be an SAE and will be 
reported as such. Any post-study pregnancy related SAE considered reasonably related to 
the study treatment by the investigator will be reported to the sponsor as described in 
Section 9.2. While the investigator is not obligated to actively seek this information in 
former study participants, he or she may learn of an SAE through spontaneous reporting.  
• 
Any female participant who becomes pregnant while participating in the study will not be 
withdrawn from the study. 
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Appendix 6 
Forbidden medication 
CYPs inducer/inhibitor/substrate, P-gp substrate (non-exhaustive list) 
 
Compound international 
nonproprietary name (INN) 
Terminal half 
life 
Reason for exclusion 
Aliskiren 
38h 
Pgp substrate 
Amiodarone 
25 days 
CYP2C and CYP3A inhibitor 
Atomoxetine 
20h 
main CYP2D6 substrate 
Avasimibe 
24h 
CYP inducer 
Boceprevir 
3h 
Strong CYP3A inhibitor 
Bosentan 
7h 
CYP inducer 
Carbamazepine 
15h 
CYP inducer 
Carvedilol 
2h 
main CYP2D6 substrate 
Chlorpromazine 
30h 
main CYP2D6 substrate 
Clarithromycin 
3h 
Strong CYP3A inhibitor 
Colchicine 
31h 
Pgp substrate 
Conivaptan 
5h 
Strong CYP3A inhibitor 
Dabigatran etexilate 
11h 
Pgp substrate 
Danoprevir/ritonavir 
2h/5h 
Strong CYP3A inhibitor 
Desipramine 
28h 
main CYP2D6 substrate 
Dextromethorphan 
3h 
main CYP2D6 substrate 
Digoxin 
36h 
Pgp substrate 
Efavirenz 
3 days 
CYP inducer 
Elvitegravir/ritonavir 
8h/5h 
Strong CYP3A inhibitor 
Encainide 
3h 
main CYP2D6 substrate 
Enzalutamide 
6h 
CYP inducer 
Etoposide 
8h 
Pgp substrate 
Etravirine 
40h 
CYP inducer 
Everolimus 
30h 
Pgp substrate 
Fexofenadine 
15h 
Pgp substrate 
Flecainide 
11h 
main CYP2D6 substrate 
Fluconazole 
32h 
Strong CYP2C inhibitor 
Fluoxetine 
2 days 
CYP2C and CYP3A inhibitor 
Fluvoxamine 
15h 
Strong CYP2C inhibitor 
(electronic 
 
 
 
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13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
Page 74 
 
Compound international 
nonproprietary name (INN) 
Terminal half 
life 
Reason for exclusion 
Gemfibrozil 
1h 
Strong CYP2C inhibitor 
Genistein 
8h 
CYP inducer 
Grapefruit juice 
- 
Strong CYP3A inhibitor 
Imipramine 
16h 
main CYP2D6 substrate 
Indinavir, Indinavir/ritonavir 
2h/5h 
Strong CYP3A inhibitor 
Itraconazole 
21h 
Strong CYP3A inhibitor 
Ketoconazole 
3h 
Strong CYP3A inhibitor 
Lapatinib 
14h 
Pgp substrate 
Lersivirine 
6h 
CYP inducer 
Linezolide 
5h 
Pgp substrate 
Loperamide 
11h 
Pgp substrate 
Lopinavir, Lopinavir/ritonavir 
5h 
Strong CYP3A inhibitor, CYP 
inducer 
Maprotiline 
45h 
main CYP2D6 substrate 
Maraviroc 
18h 
Pgp substrate 
Metoprolol 
3h 
main CYP2D6 substrate 
Mibefradil 
22h 
Strong CYP3A inhibitor 
Miconazole 
24h 
Strong CYP2C inhibitor 
Mitotane 
18-159 days 
Potent CYP inducer 
Modafinil 
11h 
CYP inducer 
Nafcillin 
2h 
CYP inducer 
Nebivolol 
11h 
main CYP2D6 substrate 
Nefazodone 
4h 
Strong CYP3A inhibitor 
Nelfinavir 
5h 
Strong CYP3A inhibitor 
Nilotinib 
17h 
Pgp substrate 
Nortriptyline 
31h 
main CYP2D6 substrate 
Paroxetine 
17h 
main CYP2D6 substrate 
Perphenazine 
9h 
main CYP2D6 substrate 
Phenobarbital 
4 days 
CYP inducer 
Phenytoine 
24h 
CYP inducer 
Pimozide 
5 days 
main CYP2D6 substrate 
Posaconazole 
35h 
Strong CYP3A inhibitor, Pgp 
substrate 
Propafenone 
6h 
main CYP2D6 substrate 
(electronic 
 
 
 
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13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
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Compound international 
nonproprietary name (INN) 
Terminal half 
life 
Reason for exclusion 
Propranolol 
4h 
main CYP2D6 substrate 
Ranolazine 
7h 
Pgp substrate 
Rifabutine 
28-62h 
CYP inducer 
Rifampin 
4h 
CYP inducer 
Rifapentine 
18h 
CYP inducer 
Risperidone 
3h 
main CYP2D6 substrate 
Ritonavir 
5h 
Strong CYP3A inhibitor 
Saquinavir, Saquinavir/ritonavir 
12h/5h 
Strong CYP3A inhibitor, Pgp 
substrate 
Semagacestat 
2.5h 
CYP inducer 
Sirolimus 
62h 
Pgp substrate 
St John’s wort 
- 
CYP inducer 
Talinolol 
9h 
Pgp substrate 
Talviraline 
- 
CYP inducer 
Telaprevir 
11h 
Strong CYP3A inhibitor 
Telithromycin 
12h 
Strong CYP3A inhibitor 
Thioridazine 
24h 
main CYP2D6 substrate 
Ticlopidine 
4 days 
Strong CYP2C inhibitor 
Timolol 
3h 
main CYP2D6 substrate 
Tipranavir/ritonavir 
6h/5h 
Strong CYP3A inhibitor 
Tolterodine 
2h 
main CYP2D6 substrate 
Tolvaptan 
12h 
Pgp substrate 
Trimipramine 
24h 
main CYP2D6 substrate 
Troleandomycine 
3h 
Strong CYP3A inhibitor 
Venlafaxine 
5h 
main CYP2D6 substrate 
Voriconazole 
7h 
Strong CYP3A inhibitor 
 
Drugs known to modify QT interval (non-exhaustive list) 
 
Generic Name 
Riska
Brand Name 
Alfuzosin 
PR 
Uroxatral 
 
Amantadine 
CR 
Symmetrel and others 
Amiodarone 
KR 
Cordarone and others 
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Generic Name 
Riska
Brand Name 
Amisulpride 
CR 
Solian and others 
Amitriptyline 
CR 
Elavil (Discontinued 6/13) and others 
Amphotericin B 
CR 
Fungilin and others 
Anagrelide 
KR 
Agrylin and others 
Apomorphine 
PR 
Apokyn and others 
Aripiprazole 
PR 
Abilify and others 
Arsenic trioxide 
KR 
Trisenox 
Artenimol+piperaquine 
PR 
Eurartesim 
Asenapine 
PR 
Saphris and others 
Astemizole 
KR 
Hismanal 
Atazanavir 
CR 
Reyataz and others 
Atomoxetine 
PR 
Strattera 
Azithromycin 
KR 
Zithromax and others 
Bedaquiline 
PR 
Sirturo 
Bendamustine 
PR 
Treanda and others 
Bendroflumethiazide or bendrofluazide 
CR 
Aprinox 
Bepridil 
KR 
Vascor 
Bortezomib 
PR 
Velcade and others 
Bosutinib 
PR 
Bosulif 
Buprenorphine 
PR 
Butrans and others 
Capecitabine 
PR 
Xeloda 
Ceritinib 
PR 
Zykadia 
Chloral hydrate 
CR 
Aquachloral and others 
Chloroquine 
KR 
Aralen 
Chlorpromazine 
KR 
Thorazine and others 
Cilostazol 
KR 
Pletal 
Ciprofloxacin 
KR 
Cipro and others 
Cisapride 
KR 
Propulsid 
Citalopram 
KR 
Celexa and others 
Clarithromycin 
KR 
Biaxin and others 
Clomipramine 
PR 
Anafranil 
Clozapine 
PR 
Clozaril and others 
Cocaine 
KR 
Cocaine 
Crizotinib 
PR 
Xalkori 
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Generic Name 
Riska
Brand Name 
Cyamemazine (cyamepromazine) 
PR 
Tercian 
Dabrafenib 
PR 
Tafinlar 
Dasatinib 
PR 
Sprycel 
Degarelix 
PR 
Firmagon 
Delamanid 
PR 
Deltyba 
Desipramine 
PR 
Pertofrane and others 
Deutetrabenazine 
PR 
Austedo 
Dexmedetomidine 
PR 
Precedex and others 
Diphenhydramine 
CR 
Benadryl and others 
Disopyramide 
KR 
Norpace 
Dofetilide 
KR 
Tikosyn 
Dolasetron 
PR 
Anzemet 
Domperidone 
KR 
Motilium and others 
Donepezil 
KR 
Aricept 
Doxepin 
CR 
Sinequan and others 
Dronedarone 
KR 
Multaq 
Droperidol 
KR 
Inapsine and others 
Efavirenz 
PR 
Sustiva and others 
Eliglustat 
PR 
Cerdelga 
Eribulin mesylate 
PR 
Halaven 
Erythromycin 
KR 
E.E.S. and others 
Escitalopram 
KR 
Cipralex and others 
Esomeprazole 
CR 
Nexium and others 
Ezogabine (Retigabine) 
PR 
Potiga and others 
Famotidine 
PR 
Pepcid and others 
Felbamate 
PR 
Felbatol 
Fingolimod 
PR 
Gilenya 
Flecainide 
KR 
Tambocor and others 
Fluconazole 
KR 
Diflucan and others 
Fluoxetine 
CR 
Prozac and others 
Flupentixol 
PR 
Depixol and others 
Fluvoxamine 
CR 
Faverin and others 
Furosemide (frusemide) 
CR 
Lasix and others 
Galantamine 
CR 
Reminyl and others 
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Generic Name 
Riska
Brand Name 
Garenoxacin 
CR 
Geninax 
Gatifloxacin 
KR 
Tequin 
Gemifloxacin 
PR 
Factive 
Granisetron 
PR 
Kytril and others 
Grepafloxacin 
KR 
Raxar 
Halofantrine 
KR 
Halfan 
Haloperidol 
KR 
Haldol (US & UK) and others 
Hydrochlorothiazide 
CR 
Apo-Hydro and others 
Hydrocodone - ER 
PR 
Hysinglaâ„¢ ER and others 
Hydroxychloroquine 
CR 
Plaquenil and others 
Hydroxyzine 
CR 
Atarax and others 
Ibogaine 
KR 
None 
Ibutilide 
KR 
Corvert 
Iloperidone 
PR 
Fanapt and others 
Imipramine (melipramine) 
PR 
Tofranil 
Indapamide 
CR 
Lozol and others 
Isradipine 
PR 
Dynacirc 
Itraconazole 
CR 
Sporanox and others 
Ivabradine 
CR 
Procoralan and others 
Ketanserin 
PR 
Sufrexal 
Ketoconazole 
CR 
Nizoral and others 
Lansoprazole 
CR 
Prevacid 
Lapatinib 
PR 
Tykerb and others 
Lenvatinib 
PR 
Lenvima 
Leuprolide 
PR 
Lupron and others 
Levofloxacin 
KR 
Levaquin and others 
Levomepromazine 
KR 
Nosinan and others 
Levomethadyl acetate 
KR 
Orlaam 
Levosulpiride 
KR 
Lesuride and others 
Lithium 
PR 
Eskalith and others 
Loperamide 
CR 
Imodium and many other OTC and Rx brands 
Melperone 
PR 
Bunil and others 
Mesoridazine 
KR 
Serentil 
Methadone 
KR 
Dolophine and others 
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Generic Name 
Riska
Brand Name 
Metoclopramide 
CR 
Reglan and others 
Metronidazole 
CR 
Flagyl and many others 
Midostaurin 
PR 
Rydapt 
Mifepristone 
PR 
Korlym and others 
Mirabegron 
PR 
Myrbetriq 
Mirtazapine 
PR 
Remeron 
Moexipril/HCTZ 
PR 
Uniretic and others 
Moxifloxacin 
KR 
Avelox and others 
Necitumumab 
PR 
Portrazza 
Nelfinavir 
CR 
Viracept 
Nicardipine 
PR 
Cardene 
Nilotinib 
PR 
Tasigna 
Norfloxacin 
PR 
Noroxin and others 
Nortriptyline 
PR 
Pamelor and others 
Nusinersen 
PR 
Spinraza 
Ofloxacin 
PR 
Floxin 
Olanzapine 
CR 
Zyprexa and others 
Omeprazole 
CR 
Losec and others 
Ondansetron 
KR 
Zofran and others 
Osimertinib 
PR 
Tagrisso 
Oxaliplatin 
KR 
Eloxatin 
Oxytocin 
PR 
Pitocin and others 
Paliperidone 
PR 
Invega and others 
Panobinostat 
PR 
Farydak 
Pantoprazole 
CR 
Protonix and others 
Papaverine HCl (Intra-coronary) 
KR 
none 
Paroxetine 
CR 
Paxil and others 
Pasireotide 
PR 
Signifor 
Pazopanib 
PR 
Votrient 
Pentamidine 
KR 
Pentam 
Perflutren lipid microspheres 
PR 
Definity and others 
Perphenazine 
PR 
Trilafon and others 
Pilsicainide 
PR 
Sunrythm 
Pimavanserin 
PR 
Nuplazid 
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Generic Name 
Riska
Brand Name 
Pimozide 
KR 
Orap 
Pipamperone 
PR 
Dipiperon (E.U) and others 
Posaconazole 
CR 
Noxafil and others 
Probucol 
KR 
Lorelco 
Procainamide 
KR 
Pronestyl and others 
Promethazine 
PR 
Phenergan 
Propofol 
KR 
Diprivan and others 
Prothipendyl 
PR 
Dominal and others 
Quetiapine 
CR 
Seroquel 
Quinidine 
KR 
Quinaglute and others 
Quinine sulfate 
CR 
Qualaquin 
Ranolazine 
CR 
Ranexa and others 
Ribociclib 
PR 
Kisqali 
Rilpivirine 
PR 
Edurant and others 
Risperidone 
PR 
Risperdal 
Ritonavir 
CR 
Norvir 
Romidepsin 
PR 
Istodax 
Roxithromycin 
KR 
Rulide and others 
Saquinavir 
PR 
Invirase (combo) 
Sertindole 
PR 
Serdolect and others 
Sertraline 
CR 
Zoloft and others 
Sevoflurane 
KR 
Ultane and others 
Solifenacin 
CR 
Vesicare 
Sorafenib 
PR 
Nexavar 
Sotalol 
KR 
Betapace and others 
Sparfloxacin 
KR 
Zagam 
Sulpiride 
KR 
Dogmatil and others 
Sultopride 
KR 
Barnetil and others 
Sunitinib 
PR 
Sutent 
Tacrolimus 
PR 
Prograf and others 
Tamoxifen 
PR 
Nolvadex (discontinued 6/13) and others 
Telaprevir 
CR 
Incivo and others 
Telavancin 
PR 
Vibativ 
Telithromycin 
PR 
Ketek 
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Generic Name 
Riska
Brand Name 
Terfenadine 
KR 
Seldane 
Terlipressin 
KR 
Teripress and others 
Terodiline 
KR 
Micturin and others 
Tetrabenazine 
PR 
Nitoman and others 
Thioridazine 
KR 
Mellaril and others 
Tiapride 
PR 
Tiapridal and others 
Tipiracil and Trifluridine 
PR 
Lonsurf 
Tizanidine 
PR 
Zanaflex and others 
Tolterodine 
PR 
Detrol and others 
Toremifene 
PR 
Fareston 
Torsemide 
CR 
Demadex and others 
Trazodone 
CR 
Desyrel (discontinued 6/13) and others 
Trimipramine 
PR 
Surmontil and others 
Tropisetron 
PR 
Navoban and others 
Valbenazine 
PR 
Ingrezza 
Vandetanib 
KR 
Caprelsa 
Vardenafil 
PR 
Levitra 
Vemurafenib 
PR 
Zelboraf 
Venlafaxine 
PR 
Effexor and others 
Voriconazole 
CR 
VFend 
Vorinostat 
PR 
Zolinza 
Ziprasidone 
CR 
Geodon and others 
Zotepine 
PR 
Losizopilon and others  
a KR: Known Risk of Torsade de Pointe (TdP); PR: Possible Risk of TdP; CR: Conditional Risk of TdP 
Source: https://www.crediblemeds.org/pdftemp/pdf/CombinedList.pdf, list last reviewed on  
22-July-2017. 
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Appendix 7 
Liver and other safety: suggested actions and follow-up 
assessments 
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Neutrophils < 1500/mm3 or according to ethnic 
group
NEUTROPENIA
Repeat immediately a full blood count if value 
close to 1500/mm3
Neutrophils < 1500/mm3 confirmed 
with signs of infection  
Neutrophils < 1500/mm3 confirmed 
with no signs of infection  
1.
DISCONTINUE
Investigational Medicinal 
Product, hospitalization 
should be considered
2.
PERFORM biological 
investigations for infection
1.
DISCONTINUE
Investigational 
Medicinal Product
2.
INVESTIGATE for 
infection
In both situations
3.
INFORM the local monitor
4.
INVESTIGATE previous treatments particularly long-term, even a long time ago, 
exposure to toxic agents, e.g., benzene, X-rays, etc.
5.
PERFORM and collect the following investigations (results): 
•
RBC and platelet counts
•
Serology: EBV, (HIV), mumps, measles, rubella
6.
DECISION for bone marrow aspiration: to be taken in specialized unit
7.
COLLECT/STORE one sample following handling procedures described in PK 
sections (for studies with PK sampling) and freeze one serum sample (5 mL) on 
Day 1 (cessation of investigational medicinal product) and Day 5 (for further 
investigations)
8.
MONITOR the leukocyte count 3 times per week for at least one  week, then twice a 
month until it returns to normal
Note: 
•The procedures described in the above flowchart are to be discussed with the patient only in case 
the event occurs. If applicable (according to local regulations), an additional consent (e.g., for 
HIV testing) will only be obtained in the case the event actually occurs.
•For individuals of African descent, the relevant value of concern is <1000/mm3
 
Neutropenia is to be recorded as an AE only if at least 1 of the criteria listed in the general 
guidelines for reporting adverse events in Appendix 4 is met. Due to single dose regimen, 
instructions regarding IMP discontinuation/resumption do not apply. 
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Platelets < 100 000/mm3 (rule out EDTA – induced 
pseudo-thrombocytopenia)
THROMBOCYTOPENIA
Repeat immediately the count (rule out EDTA 
anticoagulant in the sample)
Platelets  < 100 000/mm3 confirmed 
with bleeding  
Platelets  < 100 000/mm3 confirmed 
with no bleeding
1.
DISCONTINUE
Investigational Medicinal 
Product
2.
HOSPITALIZATION
should be considered
1.
DISCONTINUE
Investigational Medicinal 
Product
2.
INVESTIGATE for 
bleeding
In both situations
3.
INFORM the local Monitor
4.
QUESTION about last intake of quinine (drinks), alcoholism, heparin administration
5.
PERFORM or collect the following investigations: 
•
Complete blood count, schizocytes, creatinine
•
Bleeding time and coagulation test (fibrinogen, INR or PT, aPTT), Fibrin 
Degradation Product
•
Viral serology: EBV, HIV, mumps, measles, rubella
6.
COLLECT/STORE one sample following handling procedures described in PK 
sections (for studies with PK sampling) and freeze one serum sample (5 mL) on 
Day 1 (cessation of investigational medicinal product) and Day 5 (for further 
investigations)
7.
DECISION for bone marrow aspiration: to be taken in specialized unit
•
On Day 1 in the case of associated anemia and/or leukopenia
•
On Day 8 if platelets remain < 50 000/mm3
8.
MONITOR the platelet count every day for at least one week and then regularly 
until it returns to normal
Note: 
The procedures above flowchart are to be discussed with the patient only in case described in the 
the event occurs. If applicable (according to local regulations), an additional consent (e.g., for 
HIV testing) will only be obtained in the case the event actually occurs.
 
For patients with low platelets count (platelets <100,000 /mm3), after immediately repeating the 
count (rule out EDTA anticoagulant in the sample), the instructions from point 2 to 8 must be 
followed, if at least one of the following situations is present: 
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• 
If the confirmed decrease (repeat measure) is deemed by the investigator larger than 
expected due to underlying disease 
• 
50,000 /mm3 ≤Platelets <100,000 /mm3 confirmed with bleeding 
• 
Platelets <50,000 /mm3 confirmed 
Thrombocytopenia is to be recorded as an AE only if at least 1 of the criteria listed in the general 
guidelines for reporting adverse events in Appendix 4 is met. Due to single dose regimen, 
instructions regarding IMP discontinuation/resumption do not apply. 
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ALT > 3 ULN
Monitor LFTs every 72 hours
ALT ≤ 5 ULN
ALT > 3 ULN &
Total Bilirubin > 2 ULN 
Permanent Discontinuation of IMP
ALT > 5 ULN 
In ANY CASE, FOLLOW the instructions listed in the box below: 
1.
INFORM the Site Monitor who will forward the information to the Study Manager
2.
INVESTIGATE specifically for malaise with or without loss of consciousness, dizziness, and/or 
hypotension and/or episode of arrhythmia in the previous 72 hours; rule out muscular injury
3.
PERFORM the following tests:
- LFTs: AST, ALT, alkaline phosphatase, total and conjugated bilirubin and prothrombin time / INR
- CPK, serum creatinine, complete blood count
- Anti-HAV IgM, anti-HBc IgM, (HBV-DNA if clinically indicated), anti-HCV and HCV RNA, anti-
CMV IgM and anti-HEV IgM antibodies
- Depending on the clinical context, check for recent infection with EBV, herpes viruses, and toxoplasma
- Hepatobiliary ultrasonography (or other imaging investigations if needed)
4.
CONSIDER Auto-antibodies: antinuclear, anti-DNA, anti-smooth muscle, anti-LKM
5.
CONSIDER consulting with hepatologist
6.
CONSIDER patient hospitalisation if INR>2 (or PT<50%) and/or central nervous system disburbances 
suggesting hepatic encephalopathy
7.
MONITOR LFTs after discontinuation of IMP:
- As closely as possible (or every 48 hours) until stabilization, then every 2 weeks until return to 
normal/baseline or clinical resolution.
8.
FREEZE serum sample (5ml x 2)
9.
In case of SUSPICION of GILBERT Syndrome, a DNA diagnostic test should be done
COMPLETE the specific CRF forms 
for „ALT Increase” and inform the 
Monitoring Team within 24 hours
Confirm ALT > 3 ULN
Retest within 72 hours of initial sample*
IMP administration can be continued as 
long as – under close monitoring –
conditions for permanent 
discontinuation or temporary 
interruption per protocol are not met
INCREASE IN ALT
 
*If unable to retest in 72 hours, use original lab results to decide on further reporting/monitoring/discontinuation.  
Note: 
• 
“Baseline” refers to ALT sampled at baseline visit; or if baseline value unavailable, to the latest ALT sampled before the 
baseline visit. The algorithm does not apply to the instances of increase in ALT during screening. 
• 
See Appendix 4 for guidance on safety reporting.  
• 
Normalization is defined as ≤ ULN or baseline value, if baseline value is >ULN. 
• 
Due to single dose regimen, instructions regarding IMP discontinuation/resumption do not apply. 
(electronic 
 
 
 
3.0)


Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
Page 87 
 
Rapid increase in serum creatinine over 150 µmol/L 
or rapid decrease in creatinine clearance below
50 mL/mn
INCREASE IN SERUM CREATININE
Can be rapidly reversed:
• By volume repletion
• Or relief of urinary tract 
obstruction (according to etiology)
Cannot be rapidly reversed: 
• Occurrence/aggravation of life 
threatening symptoms of ARF: anemia, 
hyperkalemia, hyperuricemia, metabolic 
acidosis, cardiac insufficiency, 
pulmonary edema, arrhythmia, DIC, etc.
• And/or predominant elimination of 
investigational medicinal product by 
renal route
1.
Investigational medicinal 
product may be continued
2.
MONITOR serum creatinine 
until return to baseline level
1.
INFORM the local monitor
2.
DISCONTINUE
investigational medicinal product 
administration
3.
HOSPITALIZATION should be 
considered and seek for nephrologic
advice
4.
PERFORM the following 
examinations: 
•
BP, HR, hydration status, ECG
•
Blood count
•
Liver function tests + CPK
•
Biochemistry, including urea
•
Urinalysis
5.
COLLECT/STORE one sample 
following handling procedures 
described in PK sections (for studies 
with PK sampling) and freeze one 
serum sample (5 mL) on Day 1 
(cessation of investigational 
medicinal product)
6.
MONITOR renal function until 
return to baseline level (every day at 
the beginning, then every week)
 
Increase in serum creatinine is to be recorded as an AE only if at least 1 of the criteria listed in the 
general guidelines for reporting adverse events in Appendix 4 is met. Due to single dose regimen, 
instructions regarding IMP discontinuation/resumption do not apply. 
(electronic 
 
 
 
3.0)


Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
Page 88 
 
If Increase in CPK (expressed in ULN)
> 3 ULN
Repeat immediately the count.
If confirmed, inform the local monitor and
INVESTIGATE for the origin:
- PERFORM:
•
ECG
•
CPK-MB -MM 
•
Troponin
•
Creatinine
•
Iono (k+, Ca2+)
•
Transaminases + Total and conjugated bilirubin
•
Myoglobin (serum and urines)
- COLLECT/STORE one sample following handling procedures described in PK sections (for 
studies with PK sampling) and freeze one serum sample (5 mL) on Day 1 (cessation of 
investigational medicinal product). 
- INTERVIEW the patient about a recent intensive muscular effort, trauma, convulsions, electrical 
injury, injury or stress to the skeletal muscle, multiple intramuscular injections, recent surgery, 
concomitant medications, consumption of alcohol, morphine, cocaine.
- SEARCH for alternative causes to cardiac or muscular toxicity, ie, stroke, pulmonary infarction, 
dermatomyositis or polymyositis, convulsions, hypothyroidism, delirium tremens, muscular 
dystrophies.
If either the cardiac origin or the 
rhabdomyolysis is confirmed or if CPK 
> 10 ULN:
1. DISCONTINUE investigational 
medicinal product administration
2. MONITOR CPK every 3 days for the 
first week then once weekly until return 
to normal or for at least 3 months
3. HOSPITALIZATION should be 
considered
If the cardiac origin or the rhabdomyolysis is 
ruled out and if CPK ≤10 ULN:
MONITOR CPK every 3 days for the first week 
then once weekly until return to normal or for 
at least 3 months
Muscular symptoms (myalgia, pain, weakness, 
dark urines)
Systematic CPK assessment as per 
protocol
Perform CPK
INCREASE IN CPK SUSPECTED TO BE OF NON-CARDIAC ORIGIN 
AND NOT RELATED TO INTENSIVE PHYSICAL ACTIVITY
 
(electronic 
 
 
 
3.0)


Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
Page 89 
 
Increase in CPK is to be recorded as an AE only if at least 1 of the criteria in the general 
guidelines for reporting adverse events in Appendix 4 is met. Due to single dose regimen, 
instructions regarding IMP discontinuation/resumption do not apply. 
 
(electronic 
 
 
 
3.0)


Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
Page 90 
 
Appendix 8 
Sample size determination 
Part 1: Estimated efficacy (Day 28 PCR-corrected ACPR) of FQ 200, 400, 600 and 
900 mg administrated in presence of OZ439 TPGS for different levels of baseline 
parasitemia  
Clinical trial simulations were used, consisting of simulating FQ concentrations at Day 7, baseline 
parasitemia, and then PCR-corrected ACPR at Day 28 using a model linking ACPR at Day 28 
probability to FQ concentration at Day 7 and baseline parasitemia.  
The model (eq 1) was a logistic regression modeling PCR corrected ACPR at Day 28 probability 
(p) as a function of FQ concentration at Day 7 (ConcD7FQ), Artesunate (AR) indicator (no/yes) 
and baseline log10-parasitemia. It was developed from DRI10382 data: African patients, Per 
Protocol population, excluding patients with reinfections, using the 4 arms of the DRI10382 (FQ 
4 mg/kg or AR + FQ 2, 4 or 6 mg/kg, repeated doses). Two types of analyses were done, 
classifying as failure or excluding patients with rescue therapy before/without failure, and finally 
the results of the analysis excluding patients were favored, to compensate for the possible under-
estimation of FQ single dose effect (model built on repeated doses). In this analysis based on 
223 patients, the FQ efficacy was estimated to be ACPR28corr=80.9% (95% Confidence Interval 
[CI]: 66.7% to 90.9%) in arm FQ 600 mg. 
(eq 1)       log(p/(1-p)) = α + βFQ.ConcD7FQ + βAR. (AR=yes) + βBasePar.log10(BasePar) 
FQ concentrations at Day 7 (168 h post dose) were simulated from the FQ PopPK model updated 
from DRI12805 (POH0456) for TPGS formulation and single dose administration, in an African 
adult population (weights resampled from 194 profiles of African adults of DRI10382 and 
DRI12805 cohort 1A and 1B, of median weight 55 kg and median age 21 years). Log-normal 
distributions were fitted to these simulated concentrations and then used for simulation.  
Baseline parasitemia was simulated for different scenarii, using truncated log-normal 
distributions. The base assumption was a baseline parasitemia greater than 1000 parasites/µL and 
of median about 10,000 parasites/µL. Some other scenarii were considered: baseline parasitemia 
greater than 3000, 5000, or 10,000 parasites/µL, with a maximum fixed at 5.5 log10 parasites/µL. 
In the following, the baseline parasitemia greater than 3000 parasites/µL scenario was selected to 
ensure a better enrollment of patients during the study.   
Based on N=10,000 simulations/arm and S=1000 simulations for the model parameters 
uncertainty, the results showed a PCR-corrected ACPR at Day 28 estimated at 72% (90%CI: 
[57% to 84%]) for FQ 400mg alone and 79% (90%CI: 67% to 87%) for FQ 600 mg alone for a 
baseline parasitemia greater than 3000 parasites/µL. Finally the FQ fixed dose of 400 mg was 
selected.    
(electronic 
 
 
 
3.0)


Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
Page 91 
 
Part 2: Estimated power for various sample size of an OZ439 exposure-effect 
analysis, considering the fixed FQ dose, the 4 selected OZ439 dose levels (0, 300, 
600, 1000 mg) and the selected baseline parasitemia  
Simulation of clinical trials 
Clinical trial simulations were used to simulate trials of 4 arms with a fixed dose of 400 mg FQ 
and 4 dose levels of OZ439 (0, 300, 600, and 1000 mg) for a baseline parasitemia greater than 
3000 parasites/µL. FQ and OZ439 concentrations at Day 7 (168 h post dose) were simulated using 
log-normal distributions that were adjusted to concentrations obtained from the FQ PopPK model 
and from the OZ439 PopPK model in an African adult population (as in part 1), and were 
assumed to be slightly correlated. Truncated log-normal distributions were used to simulate 
baseline parasitemia greater than 3000 parasites/µL  in log10Par/µL by a normal distribution:  
mean=4, SD=0.55, minimum=3.48; maximum=5.5 (minimum and maximum for the truncation). 
Day 28 PCR-corrected ACPR was simulated using a “hypothetical” model linking ACPR at Day 
28 probability to FQ and OZ439 concentration at Day 7 and baseline parasitemia.   
The “hypothetical” logistic regression model (eq 2, see below) used for simulations was a 
composite of the “PQP/OZ-ACPR28 model” built by MMV, modeling PCR-corrected ACPR at 
Day 28 probability (p) as a function of OZ439 and PQP concentrations at Day 7 and baseline 
log10-parasitemia, and of assumptions made on FQ efficacy, which were based on the results of 
part 1. Precisely, βFQ was fixed at 0.12 by calibration to get ~ 72% success ACPR at Day 28 for 
FQ 400 mg alone for a baseline parasitemia greater than 3000 parasites/µL, and the following 
parameters were extracted from the MMV model: α=3.23, βOZ439 = 0.73, and βBasePar = -1.27.  
(eq 2)       log(p/(1-p)) = α + βFQ.ConcD7FQ + βOZ439. ConcD7OZ + βBasePar.log10(BasePar) 
Using all these assumptions, the PCR-corrected ACPR at Day 28 rates simulated in the 4 arms FQ 
400 mg + OZ439 at 0, 300, 600 and 1000 mg were of 72%, 81%, 91%, and 97% for a baseline 
parasitemia greater than 3000 parasites/µL.  
Clinical trials analyses 
Exposure-effect analyses of the simulated clinical trials were performed, consisting of a logistic 
regression model of exposure at Day 7 for both drugs, with baseline parasitemia as covariate, and 
the Day 28 PCR-corrected ACPR as response variable (as in eq 2 above). Significance of OZ439 
concentration effect (βOZ439) was analyzed using a 2-sided alpha Wald test at 5%. 
Overall, five thousand trial simulations were performed, and the power was deduced as the 
percentage of significant simulated trials. Results estimated that 30 evaluable participants per 
treatment arm will yield a power around 90% to detect an OZ439 concentration effect relation (in 
a population of patients with a baseline parasitemia greater than 3000 parasites/µL, for 4 arms FQ 
400 mg + OZ439 at 0, 300, 600, and 1000 mg).  
Around 15 % of early dropout is anticipated, consequently approximately 35 participants are to be 
included in each arm (to get 30 evaluable participants/arm) resulting in approximately 140 
participants to be enrolled in the whole study.  
(electronic 
 
 
 
3.0)


Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
Page 92 
 
A rather large uncertainty was attached to the models and to the different assumptions used to 
perform the simulations, so these results are approximate. 
(electronic 
 
 
 
3.0)


Clinical Trial Protocol 
ACT14655 – artefenomel/ferroquine 
13-Nov-2017 
Version number: 1 
 
Property of the Sanofi group - strictly confidential 
Page 93 
 
Appendix 9 
Country-specific requirements  
 
(electronic 
 
 
 
3.0)


 
 
 
 
 
 
 
 
 
ELECTRONIC SIGNATURES 
 
Signed by 
Meaning of Signature 
Server Date 
(dd-MMM-yyyy HH:mm) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ACT14655 16.1.1 Protocol
Clinical Approval
Clinical Approval

SAP_001.pdf: 
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