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

Phase 2 Completed 38 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.

Timeline

Start: 2023-03-29
Primary completion: 2024-05-28
Completion: 2024-05-28

Publications

Mombo-Ngoma G, Adoke Y, Manego RZ, Tiono AB, Tinto H, Bassat Q, Spangenberg T, Bougouma EC, Kremsner PG, Lingani M, Kibuuka A, Aide P, Kim W, Marrast AC, Tappert A, Oeuvray C, Bodding M, Seitzinger A, Okebe J. Safety, pharmacokinetics, and antimalarial efficacy of single-dose cabamiquine-pyronaridine combination therapy for the treatment of adults and adolescents with acute uncomplicated Plasmodium falciparum malaria (CAPTURE 1): a prospective, multicentre, open-label, phase 2a study. Lancet Infect Dis. 2026 Jul 16:S1473-3099(26)00233-1. doi: 10.1016/S1473-3099(26)00233-1. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CABAMIQUINE	Small molecule	330 mg	Oral
Subject	CABAMIQUINE	Small molecule	500 mg	Oral
Subject	CABAMIQUINE	Small molecule	660 mg	Oral
Subject	Pyronaridine	Unknown	360 mg	Oral
Subject	Pyronaridine	Unknown	540 mg	Oral
Subject	Pyronaridine	Unknown	720 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications