Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

March 29, 2023

Primary Completion Date

May 28, 2024

Study Completion Date

May 28, 2024

Conditions
Acute Malaria
Interventions
DRUG

M5717 330 mg

Participants will receive orally 330 mg granules of M5717 in combination with pyronaridine dispersed in water under fasting condition.

DRUG

M5717 500 mg

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.

DRUG

M5717 660 mg

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.

DRUG

Pyronaridine 360 mg

Participants will receive 360 mg of pyronaridine tablets in combination with M5717 under fasting condition.

DRUG

Pyronaridine 360 mg

Participants with weight \>=24 to \<45 kg will receive 360 mg of tablets in combination with M5717 under fasting condition.

DRUG

Pyronaridine 540 mg

Participants with weight \>=45 to \<65 kg will receive 540 mg of Pyronaridine tablets in combination with M5717 under fasting condition.

DRUG

Pyronaridine 720 mg

Participants with weight \>=65 kg will receive 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition.

Trial Locations (5)

Unknown

Institut de Recherche en Sciences de la Santé (IRSS), Nanoro

Groupe de Recherche Action en Santé (GRAS), Ouagadougou

Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné

Centro de Investigação em saúde de Manhiça/Fundação Manhiça (CISM/FM), Maputo

Infectious Diseases Research Collaboration (IDRC), Tororo

All Listed Sponsors
lead

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY