NCT05689047

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

Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 Plus Pyronaridine Administered Once Daily for 1 or 2 Days to Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (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

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.

Conditions

• Acute Malaria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-29
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2023-01-18
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

5 sites across 4 countries: Burkina Faso, Gabon, Mozambique, Uganda