Clinical trial NCT05689047
Conditions: Acute Malaria
Keywords: M5717 Plasmodium mutants Acute Malaria Pyronaridine Plasmodium falciparum Polymerase chain reaction Adequate Clinical and Parasitological Response Plasmodium eukaryotic translation Elongation Factor 2
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Start date: 2023-03-29; Completion date: 2024-05-28
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.

Detailed description:

Arms: arm 1: M5717 and pyronaridine once daily in a single day treatment regimen at low dose of 330 milligrams (mg) and 360 mg respectively. arm 2: After completion of Part A, if dose will be considered safe and well tolerated, the Internal Data Monitoring Committee (IDMC) will have the option to recommend dose adjustments. M5717 and pyronaridine once daily will be administered in an escalated dose in a single day or 2-day treatment regimen.
Interventions: intervention 1: M5717 330 mg intervention 2: M5717 500 mg intervention 3: M5717 660 mg intervention 4: Pyronaridine 360 mg intervention 5: Pyronaridine 360 mg intervention 6: Pyronaridine 540 mg intervention 7: Pyronaridine 720 mg
Intervention descriptions: intervention 1: Participants will receive orally 330 mg granules of M5717 in combination with pyronaridine dispersed in water under fasting condition. intervention 2: Adolescent participants with weight less than (\<) 45 kilograms (kg) will receive orally 500 mg granules of M5717 in combination with pyronaridine dispersed in water once daily under fasting condition. intervention 3: Adult and adolescent participants with weight more than or equal to (\>=) 45 kg will receive orally 660 mg granules of M5717 in combination with pyronaridine dispersed in water once daily under fasting condition. intervention 4: Participants will receive 360 mg of pyronaridine tablets in combination with M5717 under fasting condition. intervention 5: Participants with weight \>=24 to \<45 kg will receive 360 mg of tablets in combination with M5717 under fasting condition. intervention 6: Participants with weight \>=45 to \<65 kg will receive 540 mg of Pyronaridine tablets in combination with M5717 under fasting condition. intervention 7: Participants with weight \>=65 kg will receive 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition.

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
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Integrated Analysis Plan  
 
Study Number: 
MS201618_0033 
  
Clinical Study 
Protocol Title: 
Phase IIa Proof of Concept, Multicenter, 
Randomized, Open-label Study to Evaluate the 
Safety, Efficacy, and Pharmacokinetics of the 
Combination M5717 plus Pyronaridine 
Administered Once Daily for 1 or 2 Days to Adults 
and Adolescents with Acute Uncomplicated 
Plasmodium falciparum Malaria 
 
Study Phase: 
IIa 
Merck Compound: 
M5717 
Protocol Version: 
02 November 2022/Version 3.0 
 
Integrated Analysis 
Plan Author: 
Coordinating Author 
 
 
 
 
Function 
Author(s) / Data Analyst(s) 
 
 
 
 
Integrated Analysis 
Plan 
Date and Version: 
21 October 2024 / Version 2.0 
Integrated Analysis 
Plan Reviewers: 
Function 
Name 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PPD
PPD
PPD
PPD


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Confidential 
This document is the property of Merck Healthcare KGaA, Darmstadt, Germany, or one of its affiliated companies. 
It is intended for restricted use only and may not - in full or part - be passed on, reproduced, published or used without 
express permission of Merck Healthcare KGaA, Darmstadt, Germany or its affiliate.  
Copyright © [2023] by Merck Healthcare KGaA, Darmstadt, Germany or its affiliate. All rights reserved. 
 
 
 


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Approval Page  
 
Integrated Analysis Plan: MS201618_0033 
Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to  
Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 plus 
Pyronaridine Administered Once Daily for 1 or 2 Days to Adults and Adolescents  
with Acute Uncomplicated Plasmodium falciparum Malaria 
Approval of the IAP by all Merck Data Analysis Responsible has to be documented within EDMS 
via eSignature. With the approval, the Merck responsible for each of the analysis also takes 
responsibility that all reviewers’ comments are addressed adequately. 
By using eSignature, the signature will appear at the end of the document. 


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1 
Table of Contents  
1 
Table of Contents ..................................................................................4 
2 
List of Abbreviations and Definition of Terms ....................................7 
3 
Modification History ............................................................................9 
4 
Purpose of the Integrated Analysis Plan ...............................................9 
5 
Objectives and Endpoints .....................................................................9 
6 
Overview of Planned Analyses ...........................................................17 
7 
Changes to the Planned Analyses in the Clinical Study Protocol ......17 
8 
Analysis Sets .......................................................................................18 
8.1 
Definition of Analysis Sets .................................................................18 
9 
General Specifications for Data Analyses ..........................................19 
9.1 
Treatment Cohorts ..............................................................................19 
9.2 
Investigational Medical Product (IMP) ..............................................19 
9.3 
Presentation of Tables/Listings/Figures .............................................19 
9.4 
Analysis visit windows .......................................................................20 
9.5 
Software ..............................................................................................20 
9.6 
Data Handling After Cut-off Date ......................................................20 
9.7 
Definition of Baseline and Change from Baseline .............................20 
9.8 
Study Day / Study Intervention Day ...................................................21 
9.9 
Definition of Duration, ‘Time to’ and ‘Time Since’ Variables ..........21 
9.10 
Conversion Factors .............................................................................21 
9.11 
Date of Last Contact ...........................................................................22 
9.12 
Definition of On-treatment Period ......................................................22 
9.13 
Imputation of Missing Data ................................................................22 
10 
Study Participants ...............................................................................23 
10.1 
Disposition of Participants and Discontinuations ...............................23 
10.2 
Protocol Deviations ............................................................................24 
10.2.1 
Important Protocol Deviations ............................................................24 
10.2.2 
Reasons Leading to the Exclusion from an Analysis Set ...................24 
11 
Demographics and Other Baseline Characteristics .............................24 
11.1 
Demographics .....................................................................................24 
11.2 
Medical History ..................................................................................24 


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11.3 
Other Baseline Characteristics ............................................................24 
12 
Previous or Concomitant Therapies ....................................................24 
13 
Study Intervention: Compliance and Exposure ..................................25 
14 
Efficacy Analyses ...............................................................................25 
14.1 
Crude and PCR-adjusted ACPR at Various Timepoints ....................25 
14.2 
Early Treatment Failure (ETF) ...........................................................26 
14.3 
Late Clinical Failure (LCF) ................................................................27 
14.4 
Late Parasitological Failure (LPF)......................................................27 
14.5 
Fever clearance time ...........................................................................27 
14.6 
Parasite clearance time .......................................................................29 
15 
Safety Analyses ..................................................................................30 
15.1 
Adverse Events ...................................................................................30 
15.1.1 
Treatment-Emergent Adverse Events .................................................31 
15.1.2 
Adverse Events Leading to Discontinuation of Study Intervention ...31 
15.2 
Deaths, Other Serious Adverse Events, and Other Significant 
Adverse Events ...................................................................................32 
15.2.1 
Deaths .................................................................................................32 
15.2.2 
Serious Adverse Events ......................................................................32 
15.2.3 
Other Significant Adverse Events ......................................................32 
15.3 
Disease Related Events .......................................................................32 
15.4 
Clinical Laboratory Evaluation ...........................................................32 
15.5 
Vital Signs ..........................................................................................33 
15.6 
Other Safety or Tolerability Evaluations ............................................33 
15.6.1 
ECG Evaluations ................................................................................33 
15.6.2 
Malaria Signs and Symptoms .............................................................34 
16 
Analyses of Other Endpoints/Estimands ............................................35 
16.1 
Pharmacokinetics ................................................................................35 
16.1.1 
Descriptive Statistics of PK Concentration Data ................................35 
16.1.1 
Descriptive Statistics of PK Parameter Data ......................................35 
16.1.2 
General Specifications for PK Concentration and PK Parameter 
Data .....................................................................................................36 
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16.1.3 
Estimation of Pharmacokinetic Parameters ........................................36 
16.1.3.1 
Estimation of Pharmacokinetic Parameters in Whole Blood .............37 
16.1.4 
Presentation of PK Concentration and PK Parameter Data ................39 
16.1.4.1 
Listings and Tables .............................................................................39 
16.1.4.2 
Graphical Summaries and Individual plots.........................................39 
17 
References ...........................................................................................40 
 


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2 
List of Abbreviations and Definition of Terms  
 
ACPR 
Adequate Clinical and Parasitological Response 
ADaM 
Analysis Data Model 
AE 
Adverse Event 
AESI 
Adverse events of special interest 
AT 
Aminotransferase  
ATC 
Anatomical Therapeutic Chemical classification  
AUC 
Area under the curve 
BLQ 
Below the Lower Limit of Quantification 
CDISC 
Clinical Data Interchange Standards Consortium 
CI 
Confidence Interval 
CNS 
Central nervous system 
(e)CRF 
(electronic) Case Report Form 
CSR 
Clinical Study Report 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV% 
Coefficient of variation  
ECG 
Electrocardiogram 
EDMS 
Electronic Document Management System 
ETF 
Early Treatment Failure 
FAS 
Full Analysis Set 
FU 
Follow-up 
GeoCV 
Geometric coefficient of variation 
GeoMean 
Geometic Mean 
IAP 
Integrated Analysis Plan 
ICE 
Intercurrent Event 
ICH 
International Conference on Harmonization 
ITT 
Intention To Treat 
KM 
Kaplan-Meier 
LCF 
Late Clinical Failure 
LPF 
Late Parasitological Failure 


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Max 
Maximum 
MedDRA 
Medical Dictionary for Regulatory Activities 
Min 
Minimum 
NA 
Not Applicable 
NCA 
Non-compartmental analysis 
NCI-CTCAE 
National Cancer Institute – Common Terminology Criteria for Adverse 
Events 
PK 
Pharmacokinetics 
PKAS 
PK Analysis Set 
PCR 
polymerase Chain Reaction 
PT 
Preferred Term 
QTcF 
corrected QT interval by Fridericia’ formula 
Q1 
25th percentile 
Q3 
75th percentile  
SAE 
Serious Adverse Event 
SAF 
Safety Analysis Set 
SD 
Standard Deviation 
SDTM 
Study Data Tabulation Model 
SOC 
System Organ Class 
TB 
Total Bilirubin 
TEAE 
Treatment-Emergent Adverse Event 
TLF 
Tables, Listings, and Figures 
WHO-DD 
World Health Organization Drug Dictionary 
 


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3 
Modification History  
Unique 
Identifier for 
Version 
Date of 
IAP Version 
Author 
Changes from the Previous Version 
1.0 
25SEP2024 
 
Original version 
2.0 
21OCT2024 
 
Updates in Section 7 and 14.5 to include only 
participants who had a temperature >37.5°C at the 
pre-dose visit or during the 24 hours following dosing 
will be included. If the fever medication was taken prior 
to dosing, participants will still be included for analysis. 
Strategies for intercurrent events will not apply.  
4 
Purpose of the Integrated Analysis Plan  
The purpose of this Integrated Analysis Plan (IAP) is to document technical and detailed 
specifications for the primary, secondary and 
 analyses of data collected for protocol 
MS201618_0033. Results of the analyses described in this IAP will be included in the Clinical 
Study Report (CSR). Additionally, the planned analyses identified in this IAP may be included in 
regulatory submissions or future manuscripts. Any post-hoc, or unplanned analyses performed to 
provide results for inclusion in the CSR but not identified in this prospective IAP will be clearly 
identified in the CSR. 
The IAP is based on the study protocol and protocol amendments and is prepared in compliance 
with ICH E9. It describes analyses planned in the protocol version 3.0 with changes documented 
in section 7 below. The IAP may be updated as a result of protocol amendments, clarifications, or 
corrections. The IAP will not be updated with every protocol amendment unless protocol changes 
affect data analyses describe in this IAP. Any updates to the IAP prior to data review will be 
documented in the modification history above and will be reviewed and approved accordingly. 
Any changes to the described analysis occurring after data review will be labeled as such and 
documented in the CSR.  
The wording used in this IAP is chosen to best match the respective wording in the study protocol 
template, the CSR template, CDISC requirements and special requirements for table layouts. 
Therefore, the following approach is used: 
Generally, the term ‘participant’ will be used instead of ‘subject’ or ‘patient’. However, in tables 
and listings the term ‘subject’ will be used to match CDISC requirements, except for in-text tables 
where ‘participant’ will be used to match the CSR and protocol templates. Similarly, the term 
‘study intervention’ will be used in this document instead of ‘treatment’ to match protocol and 
CSR templates, however, tables and listings will use ‘treatment’ for brevity reasons. Exceptions 
from this rule are commonly used terms like “on-treatment”, “treatment-emergent”, “treatment 
policy”, “subject-years”, “by-subject”, or names of eCRF pages like “Treatment Termination” 
page. 
5 
Objectives and Endpoints  
Part A:  
PPD
PPD
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Objectives  
Estimands/Endpoints 
Ref. # 
Primary 
To evaluate the safety and 
tolerability of the M5717-
pyronaridine combination in 
adult participants with acute 
uncomplicated malaria due to P. 
falciparum. 
Endpoint: Incidence, severity, and seriousness of study 
intervention-related treatment-emergent adverse events 
(TEAEs), as per Common Terminology Criteria for 
Adverse Events (CTCAE) v 5.0 
Additional endpoints related to safety and tolerability up 
to Day 29 (± 2 days): laboratory assessments, ECGs, and 
vital signs. 
1 
Secondary 
 
 
To characterize the PK of 
M5717 and pyronaridine in 
adult participants with acute 
uncomplicated malaria due to P. 
falciparum 
Endpoint:  
• PK profiles for M5717 and pyronaridine  
• PK parameters of M5717 and pyronaridine such as 
AUC0-tlast, AUC0-∞, AUC0-24, Cmax, t½, tmax, CL/F, VZ/F, 
when data permits 
2 
To describe the clinical efficacy 
of the M5717-pyronaridine 
combination in adult 
participants with acute 
uncomplicated malaria due to P. 
falciparum 
Endpoint: Early treatment failure (ETF) defined as 
meeting any of the following:  
 • Danger signs or severe malaria 1, 2, or 3 days after 
treatment, in the presence of parasitemia  
 • Parasitemia 2 days after treatment higher than on day of 
treatment, irrespective of axillary temperature  
 • Parasitemia 3 days after treatment with temperature ≥ 
37.5°C  
 • Parasitemia 3 days after treatment ≥ 25% of count on 
day of treatment  
Target Population: Adult patients with acute 
uncomplicated malaria due to P. falciparum  
Treatment: Single dose M5717 330 mg plus 
pyronaridine 360 mg  
Intercurrent Event Strategy:  
 • Intake of rescue medication before or at Day 4: 
Composite variable strategy, i.e., endpoint is considered 
as failure (= presence of ETF) 
 • Intake of prohibited medication that impacts treatment 
effect (e.g., drug with antimalarial activity) before or at 
Day 4: Treatment policy strategy, i.e., treatment effect is 
estimated regardless of intercurrent event (ICE) 
 • Experience of any event that affects absorption (i.e., 
vomiting within the study intervention absorptive period 
of 2 × median tmax) or immune response (severe 
immunocompromised participants): Treatment policy 
strategy, i.e., treatment effect is estimated regardless of 
intercurrent event or Principal Stratum strategy 
 • Premature study discontinuation before or at Day 4 due 
to lack of efficacy: Composite variable strategy 
 • Death due to malaria before or at Day 4: Composite 
variable strategy  
Population-level Summary: ETF rate, i.e. proportion of 
participants with ETF. 
3 
 
Endpoint: Late clinical failure (LCF) defined as: 
4 


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 • Danger signs or severe malaria in the presence of 
parasitemia on any day between 4 and 28 days after 
treatment (i.e., between Days 5 and 29) in participants 
who did not previously meet any of the criteria of ETF 
 • Presence of parasitemia on any day between 4 and 28 
days after treatment with temperature ≥ 37.5°C in 
participants who did not previously meet any of the 
criteria of ETF  
Target Population: See endpoint 3  
Treatment: See endpoint 3  
Intercurrent Event Strategy: 
 • Intake of rescue medication between 4 and 28 days 
after treatment: Composite variable strategy, i.e., 
endpoint is considered as failure (= presence of LCF) 
 • Intake of prohibited medication that impacts treatment 
effect (e.g., drug with antimalarial activity) between 4 
and 28 days after treatment: Treatment policy strategy, 
i.e., treatment effect is estimated regardless of ICE 
 • Experience of any event that affects absorption (i.e., 
vomiting within the study intervention absorptive period 
of 2 × median tmax) or immune response (severe 
immunocompromised participants): Treatment policy 
strategy, i.e., treatment effect is estimated regardless of 
intercurrent event or Principal Stratum strategy 
 • Premature study discontinuation between 4 and 28 days 
after treatment due to lack of efficacy: Composite 
variable strategy 
 • Death due to malaria between 4 and 28 days after 
treatment: Composite variable strategy  
Population-level Summary: LCF rate, i.e., proportion of 
participants with LCF 
 
Endpoint: Late parasitological failure (LPF) defined as: 
Presence of parasitemia on any day between 7 and 28 
days after treatment (i.e., between Days 8 and 29) with 
temperature < 37.5°C in participants who did not 
previously meet any of the criteria of ETF or LCF  
Target Population: See endpoint 3  
Treatment: See endpoint 3  
Intercurrent Event Strategy: 
 • Intake of rescue medication between 7 and 28 days 
after treatment: Composite variable strategy, i.e., 
endpoint is considered as failure (= presence of LPF) 
 • Intake of prohibited medication that impacts treatment 
effect (e.g., drug with antimalarial activity) between 7 
and 28 days after treatment: Treatment policy strategy, 
i.e., treatment effect is estimated regardless of ICE 
 • Experience of any event that affects absorption (i.e., 
vomiting within the study intervention absorptive period 
of 2 × median tmax) or immune response (severe 
immunocompromised participants): Treatment policy 
5 


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strategy, i.e., treatment effect is estimated regardless of 
intercurrent event 
 • Premature study discontinuation between 7 and 28 days 
after treatment due to lack of efficacy: Composite 
variable strategy or Principal Stratum strategy 
 • Death due to malaria between 7 and 28 days after 
treatment: Composite variable strategy  
Population-level Summary: LPF rate, i.e., proportion of 
participants with LPF 
 
Endpoint: Crude (polymerase chain reaction [PCR]-
uncorrected) Adequate Clinical and Parasitological 
Response (ACPR) 28 and 42 days after treatment defined 
as absence of parasitemia (thick smear/microscopy), 
irrespective of axillary temperature, in participants who 
did not previously meet any of the criteria of ETF, LCF, 
or LPF  
Target Population: See endpoint 3  
Treatment: See endpoint 3  
Intercurrent Event Strategy: 
 • Intake of rescue medication at any timepoint: 
Composite variable strategy, i.e., endpoint is considered 
as treatment failure 
 • Intake of prohibited medication that impacts treatment 
effect (e.g., drug with antimalarial activity) at any 
timepoint: Treatment policy strategy, i.e., treatment effect 
is estimated regardless of ICE 
 • Experience of any event that affects absorption (i.e., 
vomiting within the study intervention absorptive period 
of 2 × median tmax) or immune response (severe 
immunocompromised participants): Treatment policy 
strategy, i.e., treatment effect is estimated regardless of 
intercurrent event or Principal Stratum strategy 
 • Premature study discontinuation at any timepoint due to 
lack of efficacy: Composite variable strategy 
 • Death due to malaria at any timepoint: Composite 
variable strategy 
Population-level Summary: Crude ACPR rate at each 
timepoint, i.e., proportion of participants with crude 
ACPR at each timepoint 
6 
 
Endpoint: PCR-adjusted ACPR  28 and 42 days after 
treatment defined as absence of parasitemia (thick 
smear/microscopy, after adjustment for parasitemia due 
to new infections as determined by genotyping using PCR 
techniques), irrespective of axillary temperature, in 
participants who did not previously meet any of the 
criteria of ETF, LCF, or LPF. 
Target Population: see endpoint 3 
Treatment: see endpoint 3 
Intercurrent Event Strategy: see endpoint 6 
7 


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Population-level Summary: PCR-adjusted ACPR rate at 
each timepoint, i.e., proportion of participants with PCR-
adjusted ACPR at each timepoint 
 
Endpoint: Fever clearance time defined as the time from 
first dosing to the first measurement of temperature < 
37.5°C for 2 consecutive temperature readings plus 
confirmed normal temperature 24 h after the first normal 
body temperature reading. 
Target Population: Adult patients with acute 
uncomplicated malaria due to P. falciparum with an 
increased temperature (≥ 37.5°C) 
Treatment: see endpoint 3 
Intercurrent Event Strategy:  
• Intake of rescue medication within 3 days after 
treatment initiation: Composite variable strategy, i.e., 
time to fever clearance is censored at time of rescue 
medication intake. 
 • Intake of concomitant medications as a continuous 
treatment that have an impact on fever within 3 days after 
treatment initiation: Composite variable strategy, i.e., 
time to fever clearance is censored at time of concomitant 
medication intake. 
 • Intake of prohibited medication that impacts treatment 
effect (e.g., drug with antimalarial activity) within 3 days 
after treatment initiation: Composite variable strategy, 
i.e., time to fever clearance is censored at time of 
prohibited medication intake. 
• Experience of any event that affects absorption (i.e., 
vomiting within the study intervention absorptive period 
of 2 × median tmax) or immune response (severe 
immunocompromised participants): Treatment policy 
strategy, i.e., treatment effect is estimated regardless of 
intercurrent event or Principal Stratum strategy 
 • Premature study discontinuation due to lack of efficacy: 
On-treatment strategy, i.e., time to fever clearance is 
censored at the day of the last available body temperature 
assessment 
 • Death due to malaria: On-treatment strategy, i.e., time 
to fever clearance is censored at the day of the last 
available body temperature assessment 
Population-level Summary: Median fever clearance 
time as estimated by Kaplan-Meier method 
11 
 
Endpoint: Parasite clearance time defined as time from 
dosing to the first negative (no parasites) film 
(microscopy) 
Target Population: see endpoint 3 
Treatment: see endpoint 3 
Intercurrent Event Strategy: see previous endpoint 
with the exception of intake of concomitant medications, 
which is not an ICE for parasite clearance time. 
12 


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Censoring will be done at the day of the last available 
microscopy assessment. 
Population-level Summary: Median parasite clearance 
time as estimated by Kaplan-Meier method 
 
Cohort B0:  
Objectives 
Estimands/Endpoints 
Ref. # 
Primary 
To describe clinical efficacy of 
the M5717- pyronaridine 
combination in adult and 
adolescent participants with 
acute uncomplicated malaria 
due to P. falciparum 
Endpoint: PCR-adjusted ACPR 28 days after first 
treatment (i.e., on Day 29) defined as absence of 
parasitemia (thick smear/microscopy, after adjustment for 
parasitemia due to new infections as determined by 
genotyping using PCR techniques), irrespective of axillary 
temperature, in participants who did not previously meet 
any of the criteria of ETF, LCF, or LPF 
Target Population: Adult and adolescent patients with 
acute uncomplicated malaria due to P. falciparum  
19 
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Treatment: Single dose M5717 660/500 mg (adolescents 
< 45 kg) plus pyronaridine 720 mg (≥ 65 kg), 540 mg (≥ 
45 to < 65 kg), or 360 mg (≥ 24 to < 45 kg)  
 
Intercurrent Event Strategy:  
• Intake of rescue medication: Composite variable strategy, 
i.e., endpoint is considered as treatment failure (= presence 
of parasitemia) 
• Intake of prohibited medication that impacts treatment 
effect (e.g., drug with antimalarial activity) at any 
timepoint: Treatment policy strategy, i.e., treatment effect 
is estimated regardless of the ICE 
• Experience of any event that affects absorption (i.e., 
vomiting within the study intervention absorptive period of 
2 × median tmax) or immune response (severe 
immunocompromised participants): Treatment policy 
strategy, i.e., treatment effect is estimated regardless of 
intercurrent event or Principal Stratum strategy 
• Premature study discontinuation due to lack of efficacy: 
Composite variable strategy 
• Death due to malaria: Composite variable strategy 
Population-level Summary: PCR-adjusted ACPR rate, 
i.e., proportion of participants achieving PCR-adjusted 
ACPR at Day 29 
Secondary 
 
 
To describe the clinical and 
parasitological efficacy of the 
M5717-pyronaridine 
combination in adult and 
adolescent participants with 
acute uncomplicated malaria 
due to P. falciparum 
Endpoint: ETF 
Target Population: See endpoint 19  
Treatment: see endpoint 19 
Intercurrent Event Strategy: See endpoint 3 
Population-level Summary: See endpoint 3 
20 
 
Endpoint: LCF 
Target Population: See endpoint 19  
Treatment: see endpoint 19 
Intercurrent Event Strategy: See endpoint 4 
Population-level Summary: See endpoint 4 
21 
 
Endpoint: LPF 
Target Population: See endpoint 19  
Treatment: see endpoint 19 
Intercurrent Event Strategy: See endpoint 5 
Population-level Summary: See endpoint 5 
22 
 
Endpoint: Crude (PCR-uncorrected) ACPR 28 and 42 
days after treatment 
Target Population: See endpoint 19  
Treatment: see endpoint 19 
Intercurrent Event Strategy: See endpoint 6 
Population-level Summary: See endpoint 6 
23 
 
Endpoint: PCR-adjusted ACPR 42 days after treatment 
Target Population: See endpoint 19  
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Treatment: see endpoint 19 
Intercurrent Event Strategy: See endpoint 7 
Population-level Summary: See endpoint 7 
 
Endpoint: Fever clearance time 
Target Population: Adult and adolescent patients with 
acute uncomplicated malaria due to P. falciparum with an 
increased temperature (≥ 37.5°C) 
Treatment: see endpoint 19 
Intercurrent Event Strategy: See endpoint 11 
Population-level Summary: See endpoint 11 
28 
 
Endpoint: Parasite clearance time 
Target Population: See endpoint 19  
Treatment: see endpoint 19 
Intercurrent Event Strategy: See endpoint 12 
Population-level Summary: See endpoint 12 
29 
To evaluate the safety and 
tolerability of the M5717-
pyronaridine combination in 
adult and adolescent participants 
with acute uncomplicated 
malaria due to P. falciparum 
Endpoint: Incidence, severity, and seriousness of study 
intervention-related TEAEs, as per CTCAE v 5.0 
Additional endpoints related to safety and tolerability up to 
Day 29 (± 2 days): laboratory assessments, ECGs, and 
vital signs. 
33 
To characterize the PK of 
M5717 and pyronaridine in 
adult and adolescent participants 
with acute uncomplicated 
malaria due to P. falciparum in 
Cohort B0. 
Endpoint: 
 • PK profiles for M5717 and pyronaridine in Cohort B0. 
 • PK parameters of M5717 and pyronaridine such as 
AUC0-tlast, AUC0-∞, AUC0-24, Cmax, t½, tmax, CL/F, VZ/F, 
when data permits 
34 
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6 
Overview of Planned Analyses  
This IAP covers analyses of efficacy, pharmacokinetic (PK), and safety based on the data at the 
end of the study. 
7 
Changes to the Planned Analyses in the Clinical Study 
Protocol  
• Due to the study’s early termination decision by the Sponsor’s Medical Safety and Ethics 
Board based on compelling efficacy and safety in Cohorts A and Cohort B0, Cohorts B1, B2, 
and B3 were not enrolled. Therefore, mention of Pyramax and Cohorts B1, B2, and B3 have 
been removed from the study objectives and estimands (see Section 5). Additionally, no 
comparison of treatment groups as described in the protocol section 9 will be conducted. The 
following analyses as described in the protocol will not be done: a log-rank test to investigate 
differences between treatment arms in median fever clearance time, parasite clearance time, 
time to recrudescence, time to re-infection, and time to re-emergence. Additionally, no logistic 
regression models will be used to investigate factors of ACPR, ETF, LCF, or LPF.  
• For Estimands #6, 7, 23, and 24, the endpoints were changed to exclude ACPR 14 days after 
treatment. This will not be calculated as it is not meaningful.    
• For Estimands #6, 7, 19, 23, 24, the ICE strategy for intake of prohibited medication that 
impacts treatment effect was changed. A treatment policy strategy will be applied and the 
treatment effect will be estimated regardless of the ICE.  
• For Estimands #7 and 24, the ICE was changed. In the protocol section 3, the ICE strategy is 
defined as the same as for Endpoint #3 (ETF), which limits ICEs to events occurring before or 
after Day 4. However, Estimands #7 and 24 are defined as endpoints occurring >4 days after 
treatment. Thus, the ICE strategy was changed for these endpoints to those defined for 
Endpoint #6 (Crude ACPR 28 and 42 days after treatment) which defines ICE at any timepoint. 
• For Estimands #11, 12, 28, and 29, the ICE was changed. Time to fever clearance and time to 
parasite clearance will be censored at the time of intake of rescue/fever/prohibited medications 
that are taken within 3 days after treatment initiation.  
• For Estimands #11 and 28 (analysis of fever clearance), only participants who had a 
temperature >37.5°C at the pre-dose visit or during the 24 hours following dosing will be 
included. If the fever medication was taken prior to dosing, participants will still be included 
for analysis. Strategies for intercurrent events will not apply.  
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• Analysis of Estimands #8, 9, 25, and 26, crude and PCR-adjusted efficacy 8 days after 
treatment, will not be conducted as no new information would be added.  
• 
 
 
 
 
• Analysis of Estimands #13, 14, 15, 30, 31, and 32, time to recrudescence, re-infection, and re-
emergence, will not be conducted as no new information would be added. 
• For any analysis using axillary temperature, the temperature measured at other locations will 
be used instead without adjustment if the axillary temperature is not collected. The number of 
participants or visits with temperature measured at different body locations will be described 
in the footnote of the output.  
8 
Analysis Sets  
8.1 
Definition of Analysis Sets  
The following Analysis Sets will be used: 
Full Analysis Set (FAS)  
The FAS will include all enrolled participants. Participants will be analyzed according to the 
treatment assigned at enrollment as per the Intention-to-Treat principle.  
Safety Analysis Set (SAF) 
All participants, who were administered any dose of any study intervention. Analyses will consider 
participants as treated.  
PK Analysis Set (PKAS)  
All participants, who receive ≥ 1 dose of study intervention, have no clinically important protocol 
deviations or important events affecting PK, and provide ≥ 1 measurable post-dose concentration. 
Participants will be analyzed per the actual study intervention they received. All PK analyses will 
be based on this analysis set for the final analysis.  
Note that important protocol deviations or important events that lead to exclusion of participants 
from the PK Analysis Set are identified during the data review process. 
The following table summarizes the use of the analysis sets in the different analyses.  
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Analysis Set 
Analyses 
FAS 
SAF 
PK Analysis 
Set 
Baseline Characteristics 
✓ 
✓* 
 
Previous and Concomitant Therapies 
✓ 
✓* 
 
Efficacy: Primary Endpoint/Estimand 
✓ 
 
 
Efficacy: Secondary Endpoint/Estimand 
✓ 
 
 
Efficacy: 
 Endpoints/Estimands 
✓ 
 
 
Safety and Tolerability 
 
✓ 
 
PK analyses 
 
 
✓ 
*only to be created if discordance between FAS and SAF is more than 5% 
 
In addition to the above defined sets used for analysis, the Screened Analysis Set will be used only 
for the disposition table. The Screened Analysis Set contains all subjects who signed the informed 
consent. 
9 
General Specifications for Data Analyses  
9.1 
Treatment Cohorts  
For Part A and Part B Cohort B0, participants are not randomized but different doses of M5717 
and Pyronaridine are used. Unless otherwise indicated, all analyses will be presented separately 
for Part A and Part B Cohort B0. The two dose levels in Cohort B0 will be combined in the reports. 
9.2 
Investigational Medical Product (IMP) 
The IMP is the combination of M5717 and pyronaridine. For Part A, participants are administered 
330 mg of M5717 and 260 mg of pyronaridine. For Part B Cohort B0, participants are administered 
different dose levels according to body weight: 500 mg of M5717 and 360 mg of pyronaridine for 
participants ≥24 to <45 kg, 660 mg of M5717 and 540 mg of pyronaridine for participants ≥45 to 
< 65 kg, and 660 mg of M5717 and 720 mg of Pyronaridine for participants ≥65 kg.  
9.3 
Presentation of Tables/Listings/Figures  
Tables and Figures will be presented by Part, unless otherwise specified. A “Total” column will 
be included in non-efficacy tables. In the individual participant data listing all individual data will 
be listed as measured. Unless otherwise specified, all listings will be sorted by Part, M5717 dose, 
subject ID, and scheduled time point.  
Repeated and unscheduled measurements included in the listings will not be used for statistical 
analyses or summaries, unless the repeated measurement was performed due to unreliable 
values/technical reasons, e.g., clotted samples. They will be flagged as such in the listings.  
Presentation of continuous and qualitative variables 
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Unless otherwise specified, continuous variables will be summarized using descriptive statistics, 
i.e., the number of participants with non-missing values (n), the number of participants with 
missing values (nmiss), mean, standard deviation, median, 25th percentile (Q1) and 75th percentile 
(Q3), minimum, and maximum.  
Qualitative variables will be summarized by frequency counts and percentages. Unless otherwise 
stated the calculation of proportions will be based on the number of participants of the analysis set 
of interest. Therefore, counts of missing observations will be included in the denominator and 
presented as a separate category.  
Descriptive statistics by nominal visit or time point, e.g., for laboratory measurements, will include 
only data from scheduled visits.  
9.4 
Analysis visit windows  
Each participant will be followed up till Day 43 (± 2 days) or the day of premature discontinuation, 
including 4 continuous days (72 hours post first dose) in the hospital after admission, followed by 
5 out-patient visits on Days 8, 15, 22, 29, and 43 (or day of premature discontinuation). 
The time window is ± 30 minutes for each scheduled timepoint on Day 1 through Day 4. The visit 
window is ± 1 day for Day 8 and ± 2 days for Days 15, 22, 29 and 43.  
In case any assessment occurs outside of the defined timepoint/visit window, it will be allocated 
to “unscheduled”. These visits will not be included in descriptive statistics by nominal visit or time 
point and will be flagged in subject data listings. In case too many measurements are observed 
outside of the defined visit windows, it will be decided on an individual basis whether those can 
be allocated to scheduled visits in a reasonable manner during data review before database lock. 
9.5 
Software  
All the analyses will be performed in SAS® software version 9.4 or higher. 
9.6 
Data Handling After Cut-off Date  
By its nature, data after cut-off may be incomplete and subject to further change and will not be 
used for summary statistics, statistical analyses, listings or imputations.  
Stop dates are not affected by this rule, e.g. a stop date of AEs, which starts prior to the cut-off, 
but stops after date of cut-off, will not be changed. 
9.7 
Definition of Baseline and Change from Baseline  
In general, the last non-missing scheduled measurement prior to the first study intervention 
administration will be used as the baseline measurement. 


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If an assessment is planned to be performed before study intervention per protocol but the 
assessment time is not available, it will be assumed that it was performed prior and considered as 
baseline. 
If a scheduled pre-dose measurement actually occurred post-dose, then the corresponding 
measurement will be analyzed similarly to an unscheduled post-dose measurement. 
Absolute and percent changes from baseline are defined as  
 
absolute change = visit value – baseline value 
 
percent change = 100 * (visit value – baseline value) / baseline value 
9.8 
Study Day / Study Intervention Day  
If endpoints refer to specific timepoints, the timepoints given refer to days after treatment. 
Thereby, time of treatment start is defined to be on Day 1. Study day is defined relative to Day 1. 
If an endpoint defines the measurement to be taken, e.g., 7 days after treatment, this means that 
the measurement is taken on Day 8.  
9.9 
Definition of Duration, ‘Time to’ and ‘Time Since’ Variables  
Duration will be calculated as the difference between start and end dates plus 1 (e.g., the duration 
of an Adverse Event (AE) = AE end date – AE start date + 1). Durations will be calculated only 
when both dates are available, i.e. imputed dates will not be used to compute the duration unless 
otherwise specified.    
The time to an event will be calculated as date of event – reference date + 1 (e.g., ADT – 
STARTDT + 1). If time to an event is calculated in hours, then it is calculated as the difference 
between event and reference SAS datetimes divided by 3600 (e.g., (ADTM – STARTDTM) / 
3600). 
The time since an event will be calculated as: 
• Date of event – reference date + 1, if the date of event is equal or greater than the reference 
data (e.g., days in study at onset of AE = AE start date – date of randomization + 1) 
• Reference date – date of event otherwise (e.g., days since diagnosis = date of randomization 
– date of diagnosis) 
9.10 
Conversion Factors  
The following conversion factors will be used to convert days into months or years:  
1 week = 7 days, 1 month = 30.4375 days, 1 year = 365.25 days. 


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9.11 
Date of Last Contact  
The date of last contact will be derived for participants not known to have died at the analysis 
cutoff or database lock using the latest complete date prior to or at the data cutoff or database lock 
date among the following: 
• Date of last AE start date 
• Date of last blood sample 
• Date of last ECG or vital sign assessment 
• Date of last temperature or malaria signs and symptoms assessment  
Only dates associated with actual examinations of the participant reported in the eCRF will be 
used in the derivation.  Dates associated with a technical operation unrelated to participant status 
such as the date a blood sample was processed will not be used.  
9.12 
Definition of On-treatment Period  
The on-treatment period is defined as the time from the date of first dose of study intervention to 
the date of premature study termination, end of study visit date or database lock date or death, 
whichever occurs first. 
9.13 
Imputation of Missing Data  
No action will be taken to handle missing data. A participant who withdraws prior to the last 
planned observation in a study period will be included in the analyses up to the time of 
discontinuation.  
Unless otherwise specified, all data will be evaluated as observed, and no imputation method for 
missing values will be used. 
To determine treatment-emergent AEs, incomplete AE-related start dates will be imputed as 
follows: 
• In case the onset date is missing completely or missing partially but the onset month and 
year, or the onset year, are equal to the start of study intervention then the onset date will 
be imputed by the minimum of start of study intervention and AE resolution date (if not 
missing). If AE resolution date is completely or partially missing, then the study 
intervention date will be used. 
• In all other cases, the missing onset day or missing onset month will be imputed by 1.  
Incomplete or missing AE stop dates will not be imputed, since no durations of AEs are planned 
to be derived. 
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In order to allocate medications to either previous or concomitant, the following imputation rules 
for (partially) missing start dates will be applied:   
• 
If the day is missing, it will be imputed by the 1st day of the month.   
• 
If both day and month are missing the date will be imputed by 1st January.  
• 
If the date is completely missing, no imputation will be performed.  
10 
Study Participants  
The subsections in this section include specifications for reporting participant disposition and 
study intervention/study discontinuations. Additionally, procedures for reporting protocol 
deviations are provided. 
10.1 
Disposition of Participants and Discontinuations  
The following will be presented in a summary table: 
• Total number of participants screened (i.e., participants who gave informed consent) 
• Number of screened participants who discontinued from the trial prior to enrollment 
o Participant did not meet all eligibility criteria 
o Withdrew consent 
o Progressive disease 
o Lost to follow-up 
o Death 
o Other 
• Number of enrolled participants 
• Number of enrolled participants who did not receive treatment (as applicable) 
• Number of treated participants 
• Number and percentage of treated participants who completed study 
• Number and percentage of treated participants who discontinued the study, with the 
primary reason of discontinuation by treatment and overall 
A frequency table displaying the number of participants of the different Analysis Sets will be 
provided. 


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10.2 
Protocol Deviations  
10.2.1 
Important Protocol Deviations  
Important protocol deviations will be identified for all participants by either site monitoring, 
medical review processes or programming and confirmed prior to or at the Data Review Meeting 
at the latest. 
Any important protocol deviation is documented in SDTM datasets whether identified through site 
monitoring, medical review or programming. The management of protocol deviations is outside 
of this IAP document.  
A frequency table as well as a listing of important protocol deviations, will be provided based on 
the FAS.  
10.2.2 
Reasons Leading to the Exclusion from an Analysis Set  
A frequency table organized according to reason for exclusion from the PK analysis set, as well as 
a listing, will be provided. 
11 
Demographics and Other Baseline Characteristics  
11.1 
Demographics  
A summary table of demographic characteristics will be provided including age, sex, race, and 
ethnicity.  
11.2 
Medical History  
The medical history will be summarized from the “Medical History” eCRF page, using the most 
recent MedDRA version at time of database lock, preferred term as event category and system 
organ class (SOC) body term as Body System category. Each participant will be counted only once 
within each PT or SOC. 
Medical history will be displayed in terms of frequency tables: ordered by primary SOC and PT 
in alphabetical order. A listing displaying Medical History by participant will be provided. 
11.3 
Other Baseline Characteristics  
Summary and frequency tables, as applicable, will be provided for baseline ECG results (number 
of participants with abnormal ECG findings and summary statistics of ECG results for participants 
with abnormal findings), height, weight, BMI, vital signs, and laboratory results.  
12 
Previous or Concomitant Therapies  
Previous medications are defined as any medication discontinued prior to the administration of 
study intervention. If the date values do not allow a medication to be classified as previous 


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medication (e.g. due to missing dates which are not imputed; see Section 9.13), the medication 
will be considered as a concomitant medication. 
Concomitant medications are defined as any medication taken during the course of the study, with 
a starting date greater than or equal to the administration of study intervention, or with a starting 
date prior to the administration of study intervention and ongoing at the time of the administration 
of study intervention. 
The World Health Organization Drug dictionary (WHO-DD) current version at the date of data 
cut-off will be used for coding of prior and concomitant medications and they will be described 
using Preferred Term (PT) as applicable. 
A frequency table of previous and concomitant medications will be provided by ATC level 2 and 
PTs sorted by ATC and PTs in alphabetical order. 
Previous and concomitant medications will be listed. Concomitant procedures, if any, will also be 
listed.  
13 
Study Intervention: Compliance and Exposure  
M5717 + pyronaridine will be administered once as single dose on Day 1, when the participants 
are hospitalized. Thus, compliance for the combination is not applicable.  
A frequency table displaying intake of study treatment, reasons for not taking study treatment and 
number of participants with different dose combinations of M5717 and pyronaridine will be 
provided.  
14 
Efficacy Analyses  
14.1 
Crude and PCR-adjusted ACPR at Various Timepoints  
Crude ACPR 28 and 42 days after first dose is defined as absence of parasitemia (parasite count = 
0) from thick smear/microscopy, irrespective of axillary temperature, in participants who did not 
previously meet any of the criteria of ETF, LCF, or LPF.  
PCR-adjusted ACPR 28 and 42 days after first dose is defined as absence of parasitemia (parasite 
count = 0) from thick smear/microscopy after adjustment for parasitemia due to new infections as 
determined by genotyping using PCR techniques, irrespective of axillary temperature, in 
participants who did not previously meet any of the criteria of ETF, LCF, or LPF. By PCR-
adjustment all participants with parasitemia due to a new infection are considered responders. Note 
that PCR-adjusted ACPR 28 days after first dose is the endpoint of the primary estimand for Part 
B Cohort B0. 
In order to derive the population-level summary of the estimands, different intercurrent events 
(ICEs) will be considered. ICE as defined by the study protocol will be identified and handled as 
described in the following if the ICE takes place before 28 or 42 days post treatment: 


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• Intake of rescue medication: Filtering concomitant medications programmatically for all 
artemisinin-based 
combination 
therapies 
(artemether-lumefantrine, 
artesunate-
amodiaquine, dihydroartemisinin-piperaquine, artesunate-sulphadoxine-pyremethamine), 
chloroquine, quinine, halofantrine, primaquine and by medical review. A composite 
variable strategy is applied, i.e., the primary endpoint is considered as failure (= presence 
of parasitemia and no ACPR).  
• Intake of prohibited medication that impacts treatment effect (e.g., drug with 
antimalarial activity) at any timepoint: A treatment policy strategy is applied, i.e., 
treatment effect is estimated regardless of the ICE. 
• Experience of any event that affects absorption (i.e., vomiting within the study 
intervention absorptive period of 2 × median tmax) or immune response (severe 
immunocompromised participants): Filter AE data programmatically for preferred term 
(PT) “Vomiting” within the System Organ Class (SOC) “Gastrointestinal disorders” and 
by medical review. A treatment policy strategy is applied, i.e., treatment effect is estimated 
regardless of ICE.  
• Premature study discontinuation due to lack of efficacy: Participants who have primary 
reason for early termination set as “Lack of efficacy” on Study Termination eCRF. A 
composite variable strategy is applied, i.e., endpoint is considered as failure. 
• Death due to malaria: Filter SAEs programmatically for fatal events with outcome 
“death” and by medical/safety review. Death cases for which the primary reason is ticked 
as “progressive disease and/or disease-related condition” qualify as death due to malaria. 
A composite variable strategy is applied, i.e., endpoint is considered as failure. 
Participants who did not previously meet any criteria of ETF, LCF, or LPF, have no ICE, and are 
missing parasitemia data at the specified timepoint after first dose will be included in the 
denominator of the proportion and will be counted as ‘N/A’ in the summary table.  
The population-level summaries are the proportion of participants achieving PCR-adjusted/Crude 
ACPR 28/48 days after first treatment (ACPR rates). ACPR rates will be estimated with 95% 
confidence intervals. Confidence intervals will be derived by use of Wilson’s score method.  
14.2 
Early Treatment Failure (ETF)  
ETF is defined as meeting any of the following: 
a) Danger signs or severe malaria 1, 2, or 3 days after treatment (i.e., between Days 2 and 4), 
in the presence of parasitemia (parasite count > 0).  
b) Parasitemia 2 days after treatment higher than on day of treatment (defined as count at 
baseline), irrespective of axillary temperature.  
c) Parasitemia 3 days after treatment with temperature ≥ 37.5°C. 
d) Parasitemia 3 days after treatment ≥ 25% of parasite count on day of treatment (defined as 
the count at baseline).  


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The same ICEs and strategies as defined for ACPR (see Section 14.1) will be applied for ETF, 
however, limited to events that occur before or at Day 4 (i.e., 3 days after treatment). Failure is 
considered presence of ETF.  
The population-level summary is proportion of participants with ETF (ETF rate). ETF rate will be 
estimated with 95% confidence intervals. Confidence intervals will be derived by use of Wilson’s 
score method. 
14.3 
Late Clinical Failure (LCF)  
LCF is defined as meeting any of the following:  
a) Danger signs or severe malaria in the presence of parasitemia on any day between 4 and 
28 days after treatment (i.e., between Days 5 and 29) in participants who did not previously 
meet any of the criteria of ETF. 
b) Presence of parasitemia on any day between 4 and 28 days after treatment with temperature 
≥ 37.5°C in participants who did not previously meet any of the criteria of ETF.  
The same ICEs and strategies as defined for ACPR (see Section 14.1) will be applied for LCF, 
however, limited to events that occur between 4 and 28 days after treatment (i.e., between Days 5 
and 29). Failure is considered presence of LCF.     
The same analyses and population-level summaries as described for ETF will be applied for LCF. 
14.4 
Late Parasitological Failure (LPF)  
LPF is defined as presence of parasitemia on any day between 7 and 28 days after treatment (i.e., 
between Days 8 and 29) with temperature < 37.5°C in participants who did not previously meet 
any of the criteria of ETF or LCF. 
The same ICE and strategies as defined for ACPR (see Section 14.1) will be applied for LPF, 
however, limited to events that occur between 7 and 28 days after treatment (i.e., between Days 8 
and 29). Failure is considered presence of LPF.    
The same analyses and population-level summaries as described for ETF will be applied for LPF. 
14.5 
Fever clearance time  
Fever clearance time is defined as the time (in hours) from first dosing to the first measurement of 
temperature < 37.5°C for 2 consecutive temperature readings, plus confirmed normal temperature 
(< 37.5°C) 24 hours after the first normal body temperature reading. Participants who are initially 
included on documented history of fever and who do not subsequently have a documented 
temperature reading of > 37.5°C at the pre-dose visit or during the 24 hours following initial dosing 
will not be considered for the population-level summary. 
For fever clearance time, the ICEs as defined by the study protocol will be identified and handled 
as described in the following: 


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• Intake of rescue medication: See Section 14.1 for description of rescue medication. A 
composite variable strategy is applied, i.e., time to fever clearance is censored at the time 
of rescue medication intake. In order to qualify as ICE, the intake of rescue medication has 
to take place within the first 3 days after treatment initiation. 
• Intake of concomitant medications as a continuous treatment that have an impact on 
fever: 
Filtering 
concomitant 
medications 
programmatically 
for 
paracetamol, 
acetaminophen, NSAIDs (ibuprofen, naproxen), salicylic acid, and by medical review. A 
composite variable strategy is applied, i.e., time to fever clearance is censored at the time 
of first concomitant medication intake. In order to qualify as ICE, the start date of intake 
of concomitant medication has to take place within the first 3 days after treatment initiation. 
If the fever medication was taken prior to dosing, participants will still be included for 
analysis. Strategies for intercurrent events will not apply.  
• Intake of prohibited medication that impacts treatment effect (e.g., drug with 
antimalarial activity): Filtering concomitant medications programmatically for 
sulphadoxine-trimethoprim, 
doxycycline, 
quinolone 
antibiotics 
including 
fluoroquinolones, azithromycin, erythromycin and all other macrolides and by medical 
review.  A composite variable strategy is applied, i.e., time to fever clearance is censored 
at the time of prohibited medication intake. In order to qualify as ICE, the intake of 
prohibited medication has to take place within the first 3 days after treatment initiation. 
• Experience of any event that affects absorption (i.e., vomiting within the study 
intervention absorptive period of 2 × median tmax) or immune response (severe 
immunocompromised participants): See Section 14.1 for description of events affecting 
absorption or immune response. A treatment policy strategy is applied, i.e., treatment effect 
is estimated regardless of intercurrent event. 
• Premature study discontinuation due to lack of efficacy: See Section 14.1 for 
description of ICE. An on-treatment strategy is applied, i.e., time to fever clearance is 
censored at the day of the last available body temperature assessment. Note: If premature 
study discontinuation occurs after fever clearance has already been observed, then the 
strategy will not be applied. 
• Death due to malaria: See Section 14.1 for description of death due to malaria. An on-
treatment strategy is applied, i.e., time to fever clearance is censored at the day of the last 
available body temperature assessment. Note: If death occurs after fever clearance has 
already been observed, then the strategy will not be applied. 
Median fever clearance time and 95% CIs will be estimated by use of the Kaplan-Meier method. 
Confidence intervals will be calculated using log-log transformation. Participants with no fever 
clearance or ICEs will be censored at the day of the last temperature assessment. Kaplan-Meier 
plots including a table with number of participants at risk and number of events will be provided. 
To explore whether there is an impact of dose group (Part A vs. Part B Cohort B0), age 
(continuous), sex, and parasite density at baseline on time to fever clearance, a Cox Proportional 
Hazards model will be applied. 


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14.6 
Parasite clearance time  
Parasite clearance time is the duration (in days) between first dosing and the first blood draw with 
parasite clearance (parasite count = 0). The subsequent readings up till at least 6 hours from the 
first zero reading must remain zero for the presence of parasites.  
The same ICEs and strategies as defined for time to fever clearance (see Section 14.5) will be 
applied to parasite clearance time, with the exception of intake of concomitant medications with 
impact on fever, which is not an ICE for parasite clearance time. Since parasite clearance time is 
measured in days, censoring will be done at the day of the last available microscopy assessment.  
The same analysis approaches as described for fever clearance time are applicable also to parasite 
clearance time (note that for the target population for parasite clearance time the prerequisite of 
showing an increased temperature does not hold). Participants with no parasite clearance or ICEs 
will be censored at the day of the last microscopy assessment. 
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15 
 Safety Analyses  
This section includes specifications for summarizing safety endpoints that are common across 
clinical studies such as adverse events, laboratory tests, and vital signs.  
15.1 
Adverse Events  
Adverse Events will be coded according to the latest MedDRA version available at the time of 
database lock and assigned to a SOC and a PT. The severity of AEs will be graded using CTCAE 
v5.0.  
Treatment-emergent AEs (TEAEs) are those events with onset dates on or after the first 
administration of study intervention.  
Any AE occurring before the administration of study intervention on Day 1 and resolved before 
administration of study intervention or not worsening after administration of study intervention 
will be included in the AE listings but will not be included in the summary tables (unless otherwise 
stated). These will be referred to as “pre-treatment” AEs. 
Related AEs are those AEs with relationship to study treatment reported by the investigator as 
related or those of unknown relationship. 
Serious AEs are those events reported on the AE eCRF form with the serious field ticked “Yes” 
or with unknown seriousness. 
AEs leading to study discontinuation are those AEs that were referenced as reason for early 
study termination on the eCRF study termination page. 
AEs of special interest (AESIs) are liver (Aminotransferase (AT) increase, Total Bilirubin (TB) 
increase) and central nervous system (CNS) signals which will be specifically followed-up through 
laboratory surveillance and a specific physical examination at specific visits during the study. 
AESIs are AEs which have been ticked to qualify as events of special interest per protocol on the 
AE eCRF form. 
Group/SOC terms and PTs within each group/SOC will be sorted alphabetically.  
If a participant experiences more than one occurrence of the same TEAE during the trial, the 
participant will only be counted once for that treatment (the worst severity and the worst 
relationship to trial treatment will be tabulated). 
In case a participant had events with missing and non-missing grades, the maximum of the 
non-missing grades will be displayed. AEs with missing classification concerning study 
intervention relationship will be considered related to the study intervention.  
Incomplete AE-related dates will be handled as described in Section 9.13. 
AE listings will include all AEs (whether treatment-emergent or not).  


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15.1.1 
Treatment-Emergent Adverse Events  
An overview summary of TEAEs will be provided including number of participants who 
experience at least any 
• TEAE 
• Related TEAE 
• Serious TEAE 
• Related serious TEAE   
• TEAE by intensity (NCI-CTCAE grades 1-4) 
• Related TEAE by intensity (NCI-CTCAE grades 1-4) 
• AESI 
• Related AESI 
• TEAE leading to study termination 
• Related TEAE leading to study termination 
• TEAE leading to death 
• Related TEAE leading to death. 
Frequency tables of TEAEs by SOC and PT will be provided for: 
• All TEAEs 
• TEAEs at frequency threshold of 5% 
• Related TEAEs (if any) 
• Serious TEAEs (if any) 
• Related serious TEAEs (if any) 
• TEAEs of special interest (if any) 
• TEAEs leading to study termination (if any) 
• Related TEAEs leading to study termination (if any) 
• TEAEs leading to death (if any) 
• Related TEAEs leading to death (if any) 
Additionally, a summary table displaying the number of participants with TEAEs by Primary SOC 
and PT will be provided by worst severity grade. A graphical presentation of TEAEs occurring in 
>10% of participants will be provided as well. 
A listing of all AEs will be provided. The listings will include seriousness, severity grade, 
relationship with study treatment, if time-emergent, and outcome.  
15.1.2 
Adverse Events Leading to Discontinuation of Study 
Intervention  
Since the study intervention is administered as single dose treatment on Day 1, discontinuation of 
study intervention due to AEs or any other reason cannot happen.  


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15.2 
Deaths, Other Serious Adverse Events, and Other Significant 
Adverse Events  
15.2.1 
Deaths  
A listing of deaths, if any, will be provided including date and cause of death.  
15.2.2 
Serious Adverse Events  
A listing of serious AEs (SAEs), if any, will be provided.  
15.2.3 
Other Significant Adverse Events  
A listing of AESIs, if any, will be provided. 
15.3 
Disease Related Events  
Disease related events (DREs) are captured separately in the same manner as Adverse Events. A 
listing of DREs, if any, will be provided. 
15.4 
Clinical Laboratory Evaluation  
The following laboratory parameters will be measured during the trial and reported as part of the 
safety evaluation (for a detailed list of parameters refer to Appendix 10 of the protocol): 
• Hematology 
• Biochemistry 
• Coagulation 
Summary tables over time displaying absolute values and changes from baseline will be provided 
for continuous data. For a graphical presentation line plots of lab parameters standardized to times 
ULN over time will be provided for each participant. Plots will be grouped by participants of 
different M5717 doses and by lab parameters in the following way: 
• Biochemistry: 
o Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, 
Bilirubin 
o Calcium, Creatinine, Glucose, Lactate 
o Potassium, Protein, Sodium, Urea Nitrogen 
• Hematology: 
o Basophils, Eosinophils, Ery. Mean Corpuscular Hemoglobin, Ery. Mean 
Corpuscular HBG Concentration, Ery. Mean Corpuscular Volume 
o Erythrocytes, Hematocrit, Hemoglobin 
o Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes 


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• All coagulation parameters 
In addition, shift tables from baseline based on normal ranges will be provided. 
In order to investigate possible events of Hy’s Law, an eDISH Plot will be provided. 
Outputs will be presented using the Merck standard lab units (see Guidance Document Merck 
Standard Lab Units and Normal Ranges Version 2.2 for reference) unless otherwise agreed. 
Normal ranges will be provided by the local laboratories, and out of range flags will be calculated 
based on the normal ranges. Laboratory data not transferred from the central laboratory in Merck 
standard units will be converted to Merck standard units before processing. Both original units and 
SI units will be provided in the SDTM domain. 
Subject Data Listings will only be provided for subjects with abnormal test results (lower than 
LLN and higher than ULN, abnormal CS and abnormal NCS).  
15.5 
Vital Signs  
Summary tables over time displaying absolute values and changes from baseline will be provided 
for the following vital sign parameters:  
• Body temperature (°C)  
• Systolic and diastolic blood pressure (mmHg) 
• Respiration rate (bpm) 
• Pulse rate (beats/min) 
A listing of all vital signs data will be provided. 
15.6 
Other Safety or Tolerability Evaluations  
15.6.1 
ECG Evaluations  
The following analyses will be performed for each 12-lead ECG parameter (RR, PR, QRS, QT, 
ventricular rate -denoted as HR in what follows-, and QTcF): 
• Descriptive statistics at baseline, at each post-baseline time point and changes from baseline 
at each post-baseline time point 
• Frequency (number and percentage) of participants with notable ECG values according to 
the following categories by analysis visit.  
o QT/QTcF >450 ms, >480 ms, >500 ms 
• ECG interpretation (normal, abnormal/not clinically significant, abnormal/clinically 
significant) will be summarized at Baseline and during the on-treatment period. 


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• A graphical display, boxplots of change from baseline for ECG parameters will be provided 
in addition. 
Complete ECG profiles will be provided for participants with at least one notable ECG value 
(related to ECG interpretation) as defined above (i.e. abnormal clinically significant, abnormal not 
clinically significant). For these participants, all ECG parameter values collected during the study 
will be provided. 
15.6.2 
Malaria Signs and Symptoms  
A frequency table per solicited symptom over time will be provided. Total score at each timepoint 
will also be summarized.  


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16 
Analyses of Other Endpoints/Estimands  
16.1 
Pharmacokinetics  
PK evaluation will be performed by Quantitative Pharmacology, Merck Healthcare KGaA, 
Darmstadt, Germany, or by a CRO selected by the Sponsor.  
16.1.1 
Descriptive Statistics of PK Concentration Data  
PK concentrations will be descriptively summarized per nominal time point using: number of non-
missing observations (n), arithmetic mean (Mean), standard deviation (SD), coefficient of 
variation (CV%), minimum (Min), median (Median) and maximum (Max).  
Descriptive statistics will only be calculated for n > 2 in which a measurement of BLQ represents 
a valid measurement and will be taken as zero for summary statistics of PK concentration data. 
Descriptive statistics of PK concentration data will be calculated using values with the same 
precision as the source data and rounded for reporting purposes only. In export datasets, as well as 
in the SDTM PC domain, PK concentrations will be provided with full precision and will not be 
rounded. 
The following conventions will be applied when reporting descriptive statistics of PK 
concentration data: 
n 
 
0 decimal place 
Mean, Min, Median, Max, SD:  
3 significant digits 
CV%: 
 
1 decimal place 
16.1.1 
Descriptive Statistics of PK Parameter Data  
PK parameter data will be descriptively summarized using number of non-missing observations 
(n), arithmetic mean (Mean), standard deviation (SD), coefficient of variation (CV%), minimum 
(Min), median (Median), maximum (Max), geometric mean (GeoMean), the geometric coefficient 
of variation (GeoCV), 95% CI for GeoMean.  
PK parameters read directly from the measurements (i.e., Cmax) will be reported with the same 
precision as the source data. All other PK parameters will be reported to 3 significant figures.  
The following conventions will be applied when reporting descriptive statistics of PK parameter 
data: 
n 
0 decimal place 
Mean, Min, Median, Max, GeoMean, 
SD, 95% CI for GeoMean:  
3 significant digits 


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CV%, GeoCV%: 
1 decimal place 
16.1.2 
General Specifications for PK Concentration and PK 
Parameter Data  
PK concentration samples taken before the first drug administration (predose samples) will be 
assigned a time of 0 hours, as if the sample had been taken simultaneously with the study 
intervention administration.  
In case pre-dose samples have been taken after the subsequent dosing, the resulting concentrations 
will be included in concentration listings but excluded from descriptive statistics of concentrations 
and from PK parameter estimation. For post-dose samples collected outside the allowed time 
window, the resulting concentrations will be included in descriptive statistics of concentrations 
and in PK parameter estimation.  
Values below the lower limit of quantification (BLQ) will be taken as zero for summary statistics 
of PK concentration data, PK parameter estimation (e.g., AUC) and for graphical presentations.  
In case profiles have a measurable pre-dose concentration less than or equal to 5% of its Cmax 
value, the participant’s data will be included in the PK and statistical analyses without any 
adjustments. If the pre-dose value is greater than 5% of the Cmax, the participant’s data for this 
period will be included in the PK evaluation but excluded from descriptive and further statistical 
evaluation after agreement with the sponsor.  
Missing concentrations (e.g., no sample, insufficient sample volume for analysis, no result or result 
not valid) will be reported and used generally as “N.R.”. A participant who withdraws prior to the 
last planned observation will be included in the analyses up to the time of discontinuation. 
PK concentrations which are erroneous due to a sampling processing or analytical error (as 
documented in the bioanalytical report) may be excluded from the PK analysis if agreed by the 
Sponsor.  
PK concentrations and PK parameters excluded from summary statistics will not be included in 
mean figures. 
If less than 3 post-dose concentrations are available within a PK profile, derived PK parameters 
will be flagged and might be excluded from statistical evaluation after consultation with the 
Sponsor.  
16.1.3 
Estimation of Pharmacokinetic Parameters  
The computer program Phoenix® WinNonlin® version 6.4, or higher (Certara, L.P., Princeton, 
New Jersey, USA) will be used to derive PK parameters applying non-compartmental analysis 
(NCA).  


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The statistical software SAS® (Statistical Analysis System, SAS-Institute, Cary NC, USA, 
windows version 9.4 or higher) may be used to generate additional PK parameters, produce tables, 
listings and figures.  
16.1.3.1 
Estimation of Pharmacokinetic Parameters in Whole Blood  
PK parameters will be calculated using the nominal elapsed time since dosing and QC’d 
bioanalytical data sets.  
The following M5717 and pyronaridine whole blood PK parameters will be calculated where 
appropriate: 
Symbol 
Definition 
AUC0-∞  
The area under the concentration-time curve (AUC) from time zero 
(dosing time) extrapolated to infinity, based on the predicted value 
for the concentration at tlast, as estimated using the linear regression 
from λz determination. AUC0-∞= AUC0-tlast +Clast pred/λz 
AUC0-24  
The AUC from time zero (dosing time) to 24 hours post dose. 
Calculated using the mixed log linear trapezoidal rule (linear up, log 
down) using the nominal dosing interval.  
CL/F  
The apparent total body clearance of study intervention following 
extravascular administration. CL/ F= Dose p.o. /AUC0-∞. 
Cmax 
Maximum observed concentration 
t½  
Apparent terminal half-life. t½ = ln (2)/λz 
tmax  
The time to reach the maximum observed concentration collected 
during a dosing interval (unless otherwise defined, take the 1st 
occurrence in case of multiple/identical Cmax values) 
VZ/F  
The apparent volume of distribution during the terminal phase 
following extravascular administration. Vz/F = Dose/(AUC0-∞*λz) 
following single dose.  
λz  
Terminal first order (elimination) rate constant. Determined from 
the terminal slope of the log-transformed concentration curve using 
linear regression on terminal data points of the curve. 
AUC0-24/Dose  
The dose normalized AUC from time zero to 24 hours post dose. 
Normalized using the dose, using the formula AUC0-24/Dose. 
AUC0-tlast  
The AUC from time zero (= dosing time) to the time of the last 
quantifiable concentration (tlast), calculated using the mixed log-
linear trapezoidal rule (linear up, log down). 


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AUC0-tlast/Dose  
The dose normalized AUC from time zero to the last sampling time 
(tlast) at which the concentration is at or above the lower limit of 
quantification. Normalized using the dose, using the formula 
AUC0-tlast /Dose. 
AUC0-∞/Dose  
The dose normalized AUC from time zero extrapolated to infinity. 
Normalized using dose, using the formula AUC0-∞ /Dose. 
Cmax/Dose  
The dose normalized maximum concentration. Normalized using 
the dose, and the formula Cmax /Dose 
Additional PK parameters may be calculated where appropriate.  
Units for PK parameter output will be based on concentration and dose units used in the study, 
unless otherwise specified. In case concentration data units change within the study, PK parameters 
will be reported using consistent units throughout study outputs.  
The parameters Cmax, and tmax will be obtained directly from the concentration-time profiles. If 
Cmax occurs at more than one timepoint, tmax will be assigned to the first occurrence of Cmax. 
In cases BLQ concentrations occur at the end of the collection interval, these concentrations might 
be set to missing for calculations of partial AUCs after agreement with the Sponsor. This is an 
exemption to the general BLQ handling rule and should be applied in case its application would 
result in estimation of implausible partial AUC values. Implausibility is considered in cases partial 
AUCs were greater than AUC0-∞.  
The following PK parameters will be calculated for diagnostic purposes and listed, but will not be 
summarized: 
• First (λz low) and last (λz up) time point of the time interval of the log-linear regression to 
determine λz.  
• Number of data points (Nλ) included in the log-linear regression analysis to determine λz. 
• Goodness of fit statistic (adjusted Rsq) for calculation of λz. 
• Span ratio of interval over which t1/2 was estimated/t1/2 
• AUC from time tlast extrapolated to infinity given as percentage of AUC0-. (AUCextra%). 
The regression analysis should contain data from at least 3 different time points in the terminal 
phase consistent with the assessment of a straight line on the log-transformed scale. Phoenix 
WinNonlin “best fit” methodology will be used as standard. If warranted, further adjustment may 
be made by the pharmacokineticist, after agreement with the Sponsor. The last quantifiable 
concentration >LLOQ should always be included in the regression analysis, while the 
concentration at tmax and any concentrations BLQ which occur after the last quantifiable data point 
>LLOQ should not be used.  


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If AUCextra% is > 20%, the coefficient of correlation (Rsq adj) of λz is < 0.8, or the observation 
period over which the regression line is estimated (span ratio) is less than 2-fold the resulting t1/2, 
the rate constants and all derived parameters (e.g., t1/2, AUC0-, CL etc.) will be listed and included 
in the parameter outputs. 
For calculation of dose-related parameters, no dose adjustment is required since dose administered 
is expressed as the free base dose. 
16.1.4 
Presentation of PK Concentration and PK Parameter Data  
Appropriate figures or tables for PK sanity checks and/or data exploration will be performed during 
the NCA process in Phoenix® WinNonlin. These outputs from Phoenix® WinNonlin are not 
expected to be provided to the DMC, though. The following PK tables, listings, and figures will 
be produced in SAS and provided to the DMC. 
16.1.4.1 
Listings and Tables  
• Individual concentrations and descriptive statistics of concentrations by analyte, and group 
• Individual PK parameters and descriptive statistics of PK parameters by analyte, and group 
• Individual dose normalized PK parameters and descriptive statistics of dose normalized PK 
parameters by analyte, and group 
• Individual diagnostic PK parameters by analyte, matrix, day and group 
16.1.4.2 
Graphical Summaries and Individual plots   
• Arithmetic mean concentration time plots; linear (±SD for arithmetic mean) and semi-log; 
using scheduled (nominal) time points by analyte 
• Individual concentration versus time plots; linear and semi-log; using the nominal time 
points by participants and analyte,  
• Overlaid individual concentration versus time plots; linear and semi-log; by analyte,  
• Boxplots of M5717 and Pyronaridine PK parameters 


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17 
References  
Not applicable.