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

NCT05974267 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-02-06

Study results available
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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

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

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

Countries

  • Burkina Faso
  • Kenya
  • The Gambia
  • Zambia

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 NCT05974267 on ClinicalTrials.gov