drugset
drugset / Trial / NCT05974267

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

NCT05974267 ↗

Phase 2 Completed 192 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-11-28
Primary completion
2024-12-29
Completion
2024-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Atovaquone Small molecule 1000 mg Oral
Subject CABAMIQUINE Small molecule 60 mg Oral
Subject CABAMIQUINE Small molecule 200 mg Oral
Subject CABAMIQUINE Small molecule 660 mg Oral
Subject Proguanil Small molecule 400 mg Oral
Subject Pyronaridine Unknown 540 mg Oral
Subject Pyronaridine Unknown 720 mg Oral

Indications

Plasmodium falciparum malaria