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This study evaluates the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. The study will also assess the duration of protection provided by different doses of M5717 plus pyronaridine and the additional contribution of M5717 to the duration of protection using external study data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: M5717 (60 mg) + Pyronaridine | Experimental | Participants received single oral dose of M5717 60 milligram (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (Participants >= 65 kilogram [kg]) or pyronaridine 540 mg (Participants >= 45 to < 65 kg) once daily in a single day treatment regimen. |
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| Cohort 2: M5717 (200 mg) + Pyronaridine | Experimental | Participants received single oral dose of M5717 200 mg plus pyronaridine 720 mg (Participants >= 65 kg) or pyronaridine 540 mg (Participants >= 45 to < 65 kg) once daily in a single day treatment regimen. |
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| Cohort 3: M5717 (660 mg)+ Pyronaridine | Experimental | Participants received single oral dose of M5717 660 mg plus pyronaridine 720 mg (Participants >= 65 kg) or pyronaridine 540 mg (Participants >= 45 to < 65 kg) once daily in a single day treatment regimen. |
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| Cohort 4: Atovaquone-proguanil | Experimental | Participants received orally 3 doses of Malarone (fixed-dose combination of atovaquone-proguanil) once daily in a 3-day treatment regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M5717 60 mg | Drug | Participants received single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Parasitemia Since Negative Blood Smear After Treatment | The time (in days) to first recorded parasitemia (parasite count >0) since the first negative blood smear (parasite count of 0) after treatment (followed at least by 1 subsequent visit with a negative blood film), i.e. the time without a positive blood smear. Median time and 95% CI was estimated using the Kaplan Meier method for each cohort. | From treatment Day 1 up to End of observation period Day 64 (Week 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Parasitemia (Positive Blood Smear) | Percentage of participants with a positive blood smear (parasitemia) was reported. Parasitemia is the presence of parasites in blood (parasite count >0). | From treatment Day 1 up to End of observation period Day 64 (Week 10) |
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Parasitemia (Due to New Infections) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe de Recherche Action en Sante (GRAS) | Ouagadougou | Burkina Faso | ||||
| Kisumu County Referral Hospital |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: M5717 (60 mg) + Pyronaridine | Participants received a single oral dose of M5717 60 milligrams (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (for participants more than equal to (≥) 65 kilograms [kg]) or pyronaridine 540 mg (for participants ≥ 45 to less than (<) 65 kg) once daily in a single-day treatment regimen on Day 1 under fasting condition. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2023 | Dec 26, 2025 |
Open Label
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| Pyronaridine | Drug | Participants received Pyronaridine tablets orally single dose of 720 (Participants >= 65 kg) and 540 mg (Participants >= 45 to < 65 kg) on Study Day 1 under fasting condition |
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| Atovaquone-Proguanil | Drug | Participants received Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen. |
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| M5717 200 mg | Drug | Participants received single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition |
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| M5717 660mg | Drug | Participants received single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition |
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Percentage of participants with polymerase chain reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to new Infections as determined by Genotyping using PCR Techniques) was reported. |
| From treatment Day 1 up to End of observation period Day 64 (Week 10) |
| Percentage of Participants With PCR-adjusted Parasitemia (Due to Recrudescence) | Percentage of participants with polymerase chain reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques) was reported. | From treatment Day 1 up to End of observation period Day 64 (Week 10) |
| Parasite Clearance Time | Parasite clearance time defined as time from dosing to the first negative (no parasites) blood film (microscopy). Median parasite clearance time was estimated by Kaplan-Meier method | Time from dosing to the first negative (no parasites) blood film (microscopy) , assessed up to 12 weeks |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Treatment Related TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with study drug which does not necessarily had a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE was defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to study intervention. | Up to End of Study (approximately 12 Weeks) |
| Area Under the Blood Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717 and Pyronaridine | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated blood concentration at the last sampling time point at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured blood concentrations of the terminal log-linear phase. | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
| Area Under the Blood Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC 0-24) of M5717 and Pyronaridine | AUC from time zero to 24 hours post dose, calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval. | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
| Area Under the Blood Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-tlast) of M5717 and Pyronaridine | Area under the blood concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
| Apparent Total Body Clearance From Blood (CL/f) of M5717 and Pyronaridine | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from blood, CL= Dose/AUC0-inf. | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
| Maximum Observed Blood Concentration (Cmax) of M5717 and Pyronaridine | Cmax was obtained directly from the concentration versus time curve. | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
| Apparent Terminal Half-life (t1/2) of M5717 and Pyronaridine | Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
| Time to Reach the Maximum Blood Concentration (Tmax) of M5717 and Pyronaridine | Time to reach the maximum blood concentration (Tmax) was obtained directly from the concentration versus time curve. | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
| Apparent Volume of Distribution (Vz/F) During the Terminal Phase of M5717 and Pyronaridine | The Vz/f was defined as the theoretical volume in which the total amount of required to uniformly distribute to produce the desired plasma concentration. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z). Vz/f=Dose/AUC(0-inf) multiply Lambda(z). | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
| Kisumu |
| Kenya |
| MRC Unit The Gambia at LSHTM | Banjul | The Gambia |
| Ndola Teaching Hospital | Ndola | Zambia |
| FG001 | Cohort 2: M5717 (200 mg) + Pyronaridine | Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition. |
| FG002 | Cohort 3: M5717 (660 mg)+ Pyronaridine | participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition. |
| FG003 | Cohort 4: Atovaquone-proguanil | Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: M5717 (60 mg) + Pyronaridine | Participants received a single oral dose of M5717 60 milligrams (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (for participants more than equal to (≥) 65 kilograms [kg]) or pyronaridine 540 mg (for participants ≥ 45 to less than (<) 65 kg) once daily in a single-day treatment regimen on Day 1 under fasting condition. |
| BG001 | Cohort 2: M5717 (200 mg) + Pyronaridine | Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition. |
| BG002 | Cohort 3: M5717 (660 mg)+ Pyronaridine | participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition. |
| BG003 | Cohort 4: Atovaquone-proguanil | Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Parasitemia Since Negative Blood Smear After Treatment | The time (in days) to first recorded parasitemia (parasite count >0) since the first negative blood smear (parasite count of 0) after treatment (followed at least by 1 subsequent visit with a negative blood film), i.e. the time without a positive blood smear. Median time and 95% CI was estimated using the Kaplan Meier method for each cohort. | The Full Analysis Set included all randomized participants. | Posted | Median | 95% Confidence Interval | days | From treatment Day 1 up to End of observation period Day 64 (Week 10) |
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| Secondary | Percentage of Participants With Parasitemia (Positive Blood Smear) | Percentage of participants with a positive blood smear (parasitemia) was reported. Parasitemia is the presence of parasites in blood (parasite count >0). | The Full Analysis Set included all randomized participants. | Posted | Number | percentage of participants | From treatment Day 1 up to End of observation period Day 64 (Week 10) |
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| Secondary | Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Parasitemia (Due to New Infections) | Percentage of participants with polymerase chain reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to new Infections as determined by Genotyping using PCR Techniques) was reported. | The Full Analysis Set included all randomized participants. | Posted | Number | percentage of participants | From treatment Day 1 up to End of observation period Day 64 (Week 10) |
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| Secondary | Percentage of Participants With PCR-adjusted Parasitemia (Due to Recrudescence) | Percentage of participants with polymerase chain reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques) was reported. | The Full Analysis Set included all randomized participants. | Posted | Number | percentage of participants | From treatment Day 1 up to End of observation period Day 64 (Week 10) |
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| Secondary | Parasite Clearance Time | Parasite clearance time defined as time from dosing to the first negative (no parasites) blood film (microscopy). Median parasite clearance time was estimated by Kaplan-Meier method | The Full Analysis Set included all randomized participants. Here overall number of participants analyzed signifies participants who had a baseline parasite density of >0. | Posted | Median | 95% Confidence Interval | hours | Time from dosing to the first negative (no parasites) blood film (microscopy) , assessed up to 12 weeks |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Treatment Related TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with study drug which does not necessarily had a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE was defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to study intervention. | Safety Analysis Set includes all participants who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Up to End of Study (approximately 12 Weeks) |
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| Secondary | Area Under the Blood Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717 and Pyronaridine | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated blood concentration at the last sampling time point at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured blood concentrations of the terminal log-linear phase. | Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter(hour*ng/mL) | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
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| Secondary | Area Under the Blood Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC 0-24) of M5717 and Pyronaridine | AUC from time zero to 24 hours post dose, calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval. | Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
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| Secondary | Area Under the Blood Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-tlast) of M5717 and Pyronaridine | Area under the blood concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
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| Secondary | Apparent Total Body Clearance From Blood (CL/f) of M5717 and Pyronaridine | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from blood, CL= Dose/AUC0-inf. | Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per Hours (L/h) | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
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| Secondary | Maximum Observed Blood Concentration (Cmax) of M5717 and Pyronaridine | Cmax was obtained directly from the concentration versus time curve. | Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
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| Secondary | Apparent Terminal Half-life (t1/2) of M5717 and Pyronaridine | Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z. | Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
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| Secondary | Time to Reach the Maximum Blood Concentration (Tmax) of M5717 and Pyronaridine | Time to reach the maximum blood concentration (Tmax) was obtained directly from the concentration versus time curve. | Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure. | Posted | Median | Full Range | hour | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
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| Secondary | Apparent Volume of Distribution (Vz/F) During the Terminal Phase of M5717 and Pyronaridine | The Vz/f was defined as the theoretical volume in which the total amount of required to uniformly distribute to produce the desired plasma concentration. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z). Vz/f=Dose/AUC(0-inf) multiply Lambda(z). | Pharmacokinetic (PK) analysis set included all participants, who received 1 dose of M5717, had no clinically important protocol deviations/important events affecting PK, & provide at least 1 measurable post-dose concentration. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for the outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and 24 hours on Day 2 |
|
End of Study (approximately 12 Weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: M5717 (60 mg) + Pyronaridine | Participants received a single oral dose of M5717 60 milligrams (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (for participants more than equal to (≥) 65 kilograms [kg]) or pyronaridine 540 mg (for participants ≥ 45 to less than (<) 65 kg) once daily in a single-day treatment regimen on Day 1 under fasting condition. | 0 | 49 | 0 | 49 | 31 | 49 |
| EG001 | Cohort 2: M5717 (200 mg) + Pyronaridine | Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition. | 0 | 47 | 1 | 47 | 27 | 47 |
| EG002 | Cohort 3: M5717 (660 mg)+ Pyronaridine | participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition. | 0 | 48 | 0 | 48 | 31 | 48 |
| EG003 | Cohort 4: Atovaquone-proguanil | Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen. | 0 | 48 | 0 | 48 | 28 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA 27.1 | Non-systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Body tinea | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Plasmodium ovale infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Schistosomiasis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| pH urine increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Respiratory rate increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 27.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyperchloraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Hypercreatinaemia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2025 | Dec 26, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| D058345 | Asymptomatic Infections |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D058070 | Asymptomatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C027871 | pyronaridine |
| C109496 | atovaquone, proguanil drug combination |
Not provided
Not provided
Not provided
| Male |
|
| Ethnicity-Not Hispanic or Latino |
|
| Ethnicity-Not Reported |
|
| Race-Black or African American |
|
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition.
| OG003 | Cohort 4: Atovaquone-proguanil | Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen. |
|
|
| Cohort 3: M5717 (660 mg)+ Pyronaridine |
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition. |
| OG003 | Cohort 4: Atovaquone-proguanil | Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen. |
|
|
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition. |
| OG003 | Cohort 4: Atovaquone-proguanil | Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen. |
|
|
| Cohort 3: M5717 (660 mg)+ Pyronaridine |
Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition. |
| OG003 | Cohort 4: Atovaquone-proguanil | Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen. |
|
|
| OG001 |
| Cohort 2: M5717 (200 mg) + Pyronaridine |
Participants received a single oral dose of M5717 200 milligrams (mg) along with pyronaridine tetraphosphate (pyronaridine)-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition. |
| OG002 | Cohort 3: M5717 (660 mg)+ Pyronaridine | Participants received a single oral dose of M5717 660 mg along with pyronaridine-either 720 mg for those weighing ≥ 65 kilograms (kg) or 540 mg for those weighing between ≥ 45 kg and < 65 kg-as part of a single-day treatment regimen on Day 1 under fasting condition. |
| OG003 | Cohort 4: Atovaquone-proguanil | Participants received three oral doses of Malarone-a fixed-dose combination of 1000 mg atovaquone and 400 mg proguanil-administered once daily over a 3-day treatment regimen. |
|
|
| OG002 | Cohort 3: M5717 660 mg | Participants received a single oral dose of M5717 660 mg as part of a single-day treatment regimen on Day 1 under fasting condition. |
| OG003 | Cohort 1, 2 and 3: Pyronaridine 540 mg | Participants received a single pyronaridine tetraphosphate (pyronaridine) 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
| OG004 | Cohort 1, 2 and 3: Pyronaridine 720 mg | Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
|
|
| OG003 | Cohort 1, 2 and 3: Pyronaridine 540 mg | Participants received a single pyronaridine tetraphosphate (pyronaridine) 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
| OG004 | Cohort 1, 2 and 3: Pyronaridine 720 mg | Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
|
|
Participants received a single oral dose of M5717 660 mg as part of a single-day treatment regimen on Day 1 under fasting condition. |
| OG003 | Cohort 1, 2 and 3: Pyronaridine 540 mg | Participants received a single pyronaridine tetraphosphate (pyronaridine) 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
| OG004 | Cohort 1, 2 and 3: Pyronaridine 720 mg | Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
|
|
Participants received a single oral dose of M5717 660 mg as part of a single-day treatment regimen on Day 1 under fasting condition.
| OG003 | Cohort 1, 2 and 3: Pyronaridine 540 mg | Participants received a single pyronaridine tetraphosphate (pyronaridine) 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
| OG004 | Cohort 1, 2 and 3: Pyronaridine 720 mg | Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
|
|
| OG003 | Cohort 1, 2 and 3: Pyronaridine 540 mg | Participants received a single pyronaridine tetraphosphate (pyronaridine) 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
| OG004 | Cohort 1, 2 and 3: Pyronaridine 720 mg | Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
|
|
| OG003 | Cohort 1, 2 and 3: Pyronaridine 540 mg | Participants received a single pyronaridine tetraphosphate (pyronaridine) 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
| OG004 | Cohort 1, 2 and 3: Pyronaridine 720 mg | Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
|
|
| OG003 | Cohort 1, 2 and 3: Pyronaridine 540 mg | Participants received a single pyronaridine tetraphosphate (pyronaridine) 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
| OG004 | Cohort 1, 2 and 3: Pyronaridine 720 mg | Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
|
|
| OG002 | Cohort 3: M5717 660 mg | Participants received a single oral dose of M5717 660 mg as part of a single-day treatment regimen on Day 1 under fasting condition. |
| OG003 | Cohort 1, 2 and 3: Pyronaridine 540 mg | Participants received a single pyronaridine tetraphosphate (pyronaridine) 540 mg for those weighing between ≥ 45 kg and < 65 kg-in a single-day treatment regimen administered under fasting conditions on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
| OG004 | Cohort 1, 2 and 3: Pyronaridine 720 mg | Participants received 720 mg for those weighing ≥ 65 kilograms (kg) as part of a single-day treatment regimen on Day 1 under fasting condition in Cohorts 1, 2 and 3. |
|
|