| Primary | Cohort A: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant. TEAEs are defined as AEs which started at or after the administration of study intervention (study treatment) or which started prior to the first administration of study intervention but worsened after the dose intake, until the last scheduled assessment will be regarded as treatment-emergent, but before established rescue antimalarial treatment is administered, if required. A serious TEAE 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. A TEAE was considered to be "related" if a causal relationship between study treatment and the TEAE is at least reasonably possible. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 43 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet |
| | | Title | Denominators | Categories |
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| TEAEs | | | | Serious TEAEs | | | | Related TEAEs | | |
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| Primary | Cohort A: Number of Participants With Clinically Significant Change From Baseline in Safety Laboratory Parameters | Number of participants with clinically significant change from baseline in laboratory parameters were reported. Clinical Significance was decided by the investigator. Laboratory investigation included hematology, biochemistry, and coagulation. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet |
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| Primary | Cohort A: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | Number of participants with clinically significant change from baseline in ECG parameters were reported. Clinical Significance was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet |
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| Primary | Cohort A: Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Number of participants with clinically significant change from baseline in vital signs. Clinical Significance was decided by the investigator. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet |
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| Primary | Cohort B0: Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Adequate Clinical and Parasitological Response (ACPR) | PCR-adjusted ACPR 28 days after first treatment (i.e., on Day 29) was 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 Early treatment failure (ETF), Late clinical failure (LCF), or Late parasitological failure (LPF). | The Full Analysis Set included all enrolled participants. ACPR could not be assessed for 1 participant due to missing parasites assessment at Day 28. Here "Number Analyzed" is equivalent to the number of participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort B0: Dose Escalation Cohort: M5717+Pyronaridine | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally in combination with 360 mg pyronaridine daily or adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717 in combination with 540 mg pyronaridine once daily under fasting condition. Participants with weight >=65 kg received 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition. The follow up period for participants was 28 days. |
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| Secondary | Cohort A and Cohort B0: Area Under Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717 and Pyronaridine | The 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 lambda z determination. Calculated as AUC0-inf = AUC0-tlast + Clast pred/ lambda z. | The Pharmacokinetics (PK) analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide more than equal to (>=) 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram/milliliter(h*ng/ml) | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | |
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| Secondary | Cohort A and Cohort B0: Area Under Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) of M5717 and Pyronaridine | The AUC from time zero (dosing time) to 24 hours post dose was calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/ml | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. |
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| Secondary | Cohort A and Cohort B0: Area Under Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-tlast) of M5717 and Pyronaridine | 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) | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/ml | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. |
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| Secondary | Cohort A and Cohort B0: Apparent Total Clearance (CL/F) of M5717 and Pyronaridine | The apparent total body clearance of study intervention following extravascular administration. CL/ F was calculated by oral dose divided by Area under the plasma concentration curve 0- infinity. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters/hour (l/h) | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. |
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| Secondary | Cohort A and Cohort B0: Maximum Plasma Concentration (Cmax) of M5717 and Pyronaridine | Cmax was taken directly from the observed concentration-time curve. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/ml | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. | | OG003 |
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| Secondary | Cohort A and Cohort B0: Apparent Terminal Half-Life of M5717 and Pyronaridine | t1/2 was the time measured for the concentration to decrease by one half. t1/2 was calculated by natural log 2 divided by Lambda z. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours (h) | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. | |
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| Secondary | Cohort A and Cohort B0: Time to Reach Maximum Plasma Concentration (Tmax) of M5717 and Pyronaridine | tmax was obtained directly from the concentration versus time curve. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. | | OG003 |
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| Secondary | Cohort A and Cohort B0: Apparent Volume of Distribution (Vz/F) of M5717 and Pyronaridine | The apparent volume of distribution during the terminal phase following extravascular administration. Vz/F = Dose/(AUC0-∞*λz) following single dose. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liters (l) | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. |
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| Secondary | Cohort A and Cohort B0: Dose Normalized Area Under the Curve From Time Zero to 24 Hours Post Dose (AUC0-24h/Dose) of M5717 and Pyronaridine | The dose normalized AUC from time zero to 24 hours post dose. Normalized using the dose, using the formula AUC0-24/Dose. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL/mg | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. |
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| Secondary | Cohort A and Cohort B0: Dose Normalized Area Under the Curve From Time Zero to the Last Sampling Time (AUC0-tlast/Dose) of M5717 and Pyronaridine | 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. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL/mg | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. |
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| Secondary | Cohort A and Cohort B0: Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-∞/Dose) of M5717 and Pyronaridine | The dose normalized AUC from time zero extrapolated to infinity. Normalized using dose, using the formula AUC0-∞ /Dose. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL/mg | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. |
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| Secondary | Cohort A and Cohort B0: Terminal Elimination Rate Constant (Lambda z) of M5717 and Pyronaridine | Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours (h) | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. | |
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| Secondary | Cohort A and Cohort B0: Dose Normalized Maximum Concentration (Cmax/Dose) of M5717 and Pyronaridine | The dose normalized maximum concentration. Normalized using the dose, and the formula Cmax /Dose. | The PK analysis set included all participants, who received more than equal to 1 dose of study intervention, have no clinically important protocol deviations or important events affecting PK and provide >= 1 measurable post-dose concentration. Dose wise results have been reported for M5717 and Pyronaridine as per the planned analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | | Predose and Post dose on Day 1, Post dose on Day 2, 3, 4, 8, 15, 22, 29 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: M5717 330 mg | Participants received 330 milligrams (mg) granules of M5717 orally. | | OG001 | Cohort B0: M5717 500 mg | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally. | | OG002 | Cohort B0: M5717 660 mg | Adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717. | |
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| Secondary | Cohort A and Cohort B0: Percentage of Participants With Early Treatment Failure (ETF) | Early treatment failure (ETF) was defined as meeting any of the following : 1. Danger signs or severe malaria 1, 2, or 3 days after treatment, in the presence of parasitemia2. 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 3. Parasitemia 3 days after treatment ≥ 25% of count on day of treatment. ETF rate will be estimated with 95% confidence intervals. Confidence intervals was derived by use of Wilson's score method. | The Full Analysis Set (FAS) included all enrolled participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to Day 3 post treatment on Day 1 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet | | OG001 | Cohort B0: Dose Escalation Cohort: M5717+Pyronaridine | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally in combination with 360 mg pyronaridine daily or adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717 in combination with 540 mg pyronaridine once daily under fasting condition. Participants with weight >=65 kg received 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition. The follow up period for participants was 28 days. |
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| Secondary | Cohort A and Cohort B0: Percentage of Participants With Late Clinical Failure (LCF) | Late clinical failure (LCF) was defined as:1. 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. 2. 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. LCF was estimated with 95% confidence intervals. Confidence intervals will be derived by use of Wilson's score method. | The FAS included all enrolled participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 1 up to Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet | | OG001 | Cohort B0: Dose Escalation Cohort: M5717+Pyronaridine | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally in combination with 360 mg pyronaridine daily or adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717 in combination with 540 mg pyronaridine once daily under fasting condition. Participants with weight >=65 kg received 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition. The follow up period for participants was 28 days. |
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| Secondary | Cohort A and Cohort B0: Percentage of Participants With Late Parasitological Failure (LPF) | Late parasitological failure (LPF) was 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. LPF was estimated with 95% confidence intervals. Confidence intervals will be derived by use of Wilson's score method. | The FAS included all enrolled participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From Day 8 to Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet | | OG001 | Cohort B0: Dose Escalation Cohort: M5717+Pyronaridine | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally in combination with 360 mg pyronaridine daily or adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717 in combination with 540 mg pyronaridine once daily under fasting condition. Participants with weight >=65 kg received 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition. The follow up period for participants was 28 days. |
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| Secondary | Cohort A: Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Adequate Clinical and Parasitological Response (ACPR) | 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. | The FAS included all enrolled participants. ACPR could not be assessed for 1 patient due to missing parasites assessment at Day 28. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 28 and 42 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet |
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| Secondary | Cohort A and B0: Percentage of Participants With Crude Adequate Clinical and Parasitological Response (ACPR) | 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. | The FAS included all enrolled participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 28 and 42 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet | | OG001 | Cohort B0: Dose Escalation Cohort: M5717+Pyronaridine | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally in combination with 360 mg pyronaridine daily or adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717 in combination with 540 mg pyronaridine once daily under fasting condition. Participants with weight >=65 kg received 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition. The follow up period for participants was 28 days. |
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| Secondary | Cohort A and Cohort B0: Time to Fever Clearance as Estimated by Kaplan-Meier Method | Fever clearance time was 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. This analysis was done on participants with fever. | The FAS included all enrolled participants. Here "Number Analyzed" is equivalent to the number of participants evaluable for this outcome measure. | Posted | | Median | Inter-Quartile Range | hours | | Day 1 up to Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet | | OG001 | Cohort B0: Dose Escalation Cohort: M5717+Pyronaridine | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally in combination with 360 mg pyronaridine daily or adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717 in combination with 540 mg pyronaridine once daily under fasting condition. Participants with weight >=65 kg received 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition. The follow up period for participants was 28 days. |
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| Secondary | Cohort A and Cohort B0: Parasite Clearance Time as Estimated by Kaplan-Meier Method | Parasite clearance time defined as time from dosing to the first negative (no parasites) film | The FAS included all enrolled participants. | Posted | | Median | Inter-Quartile Range | days | | Day 1 up to Day 43 | | | | ID | Title | Description |
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| OG000 | Cohort A: M5717+Pyronaridine | Participants received 330 milligrams (mg) granules of M5717 orally in combination with 360 mg pyronaridine tablet | | OG001 | Cohort B0: Dose Escalation Cohort: M5717+Pyronaridine | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally in combination with 360 mg pyronaridine daily or adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717 in combination with 540 mg pyronaridine once daily under fasting condition. Participants with weight >=65 kg received 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition. The follow up period for participants was 28 days. |
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| Secondary | Cohort B0: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant. TEAEs are defined as AEs which started at or after the administration of study intervention (study treatment) or which started prior to the first administration of study intervention but worsened after the dose intake, until the last scheduled assessment will be regarded as treatment-emergent, but before established rescue antimalarial treatment is administered, if required. A serious TEAE 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. A TEAE was considered to be "related" if a causal relationship between study treatment and the TEAE is at least reasonably possible. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 43 | | | | ID | Title | Description |
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| OG000 | Cohort B0: Dose Escalation Cohort: M5717+Pyronaridine | Participants with weight less than (<) 45 kilograms (kg) received 500 mg granules of M5717 orally in combination with 360 mg pyronaridine daily or adult and adolescent participants with weight more than or equal to (>=) 45 kg received orally 660 mg granules of M5717 in combination with 540 mg pyronaridine once daily under fasting condition. Participants with weight >=65 kg received 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition. The follow up period for participants was 28 days. |
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