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

NCT05689047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-08-27

Study results available
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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

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Burkina Faso
  • Gabon
  • Mozambique
  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05689047 on ClinicalTrials.gov