NCT05974267

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

Phase 2a Proof-of-Concept, Multicenter, Randomized, Open Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of the Combination M5717-pyronaridine as Chemoprevention in Asymptomatic Adults and Adolescents With Plasmodium Falciparum Malaria Infection (CAPTURE-2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malaria Infection

Interventions

Type	Name	Description
DRUG	M5717 60 mg	Participants received single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition
DRUG	Pyronaridine	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
DRUG	Atovaquone-Proguanil	Participants received Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.
DRUG	M5717 200 mg	Participants received single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition
DRUG	M5717 660mg	Participants received single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-12-29
• Completion: 2024-12-29
• First posted: 2023-08-03
• Last updated: 2026-02-06
• Results posted: 2026-02-06

Locations

4 sites across 4 countries: Burkina Faso, Kenya, The Gambia, Zambia