NCT05974267View on ClinicalTrials.gov

Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)

PHASE2CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

November 28, 2023

Primary Completion Date

December 29, 2024

Study Completion Date

December 29, 2024

Conditions
Malaria Infection
Interventions
DRUG

M5717 60 mg

Participants will receive single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition

DRUG

Pyronaridine

Participants will receive 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

DRUG

Atovaquone-Proguanil

Participants will Receive Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.

DRUG

M5717 200 mg

Participants will receive single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition

DRUG

M5717 660mg

Participants will receive single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition

Trial Locations (4)

Unknown

Groupe de Recherche Action en Sante (GRAS), Ouagadougou

Kisumu County Referral Hospital, Kisumu

MRC Unit The Gambia at LSHTM, Banjul

Ndola Teaching Hospital, Ndola

All Listed Sponsors
lead

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

INDUSTRY

NCT05974267 - Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2) | Biotech Hunter | Biotech Hunter