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

NCT05974267 | Completed Phase 2 Results

• 1 other identifier: MS201618_0034
• Study Type: interventional
• Target: 192
• Locations: 4 countries
• Sites: 4

Brief 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

Keywords

Plasmodium falciparum; Chemoprevention; Malaria; Plasmodium eukaryotic translation elongation factor 2 (PeEF2); Exposure response; Adults; Adolescents; Asymptomatic Infection

Outcome Measures

Primary Outcomes (1)

• Time to Parasitemia Since Negative Blood Smear After Treatment

  The time (in days) to first recorded parasitemia (parasite count \>0) since the first negative blood smear (parasite count of 0) after treatment (followed at least by 1 subsequent visit with a negative blood film), i.e. the time without a positive blood smear. Median time and 95% CI was estimated using the Kaplan Meier method for each cohort.

  From treatment Day 1 up to End of observation period Day 64 (Week 10)

Secondary Outcomes (13)

• Percentage of Participants With Parasitemia (Positive Blood Smear)

  From treatment Day 1 up to End of observation period Day 64 (Week 10)

• Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Parasitemia (Due to New Infections)

  From treatment Day 1 up to End of observation period Day 64 (Week 10)

• Percentage of Participants With PCR-adjusted Parasitemia (Due to Recrudescence)

  From treatment Day 1 up to End of observation period Day 64 (Week 10)

• Parasite Clearance Time

  Time from dosing to the first negative (no parasites) blood film (microscopy) , assessed up to 12 weeks

• Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Treatment Related TEAEs

  Up to End of Study (approximately 12 Weeks)

Study Arms (4)

Cohort 1: M5717 (60 mg) + Pyronaridine

EXPERIMENTAL

Participants received single oral dose of M5717 60 milligram (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (Participants \>= 65 kilogram \[kg\]) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen.

Drug: M5717 60 mg; Drug: Pyronaridine

Cohort 2: M5717 (200 mg) + Pyronaridine

EXPERIMENTAL

Participants received single oral dose of M5717 200 mg plus pyronaridine 720 mg (Participants \>= 65 kg) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen.

Drug: Pyronaridine; Drug: M5717 200 mg

Cohort 3: M5717 (660 mg)+ Pyronaridine

EXPERIMENTAL

Participants received single oral dose of M5717 660 mg plus pyronaridine 720 mg (Participants \>= 65 kg) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen.

Drug: Pyronaridine; Drug: M5717 660mg

Cohort 4: Atovaquone-proguanil

EXPERIMENTAL

Participants received orally 3 doses of Malarone (fixed-dose combination of atovaquone-proguanil) once daily in a 3-day treatment regimen.

Drug: Atovaquone-Proguanil

Interventions

M5717 60 mg DRUG

Participants received single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition

Cohort 1: M5717 (60 mg) + Pyronaridine

Pyronaridine DRUG

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

Also known as: Pyronaridine tetraphosphate

Cohort 1: M5717 (60 mg) + Pyronaridine; Cohort 2: M5717 (200 mg) + Pyronaridine; Cohort 3: M5717 (660 mg)+ Pyronaridine

Atovaquone-Proguanil DRUG

Participants received Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.

Cohort 4: Atovaquone-proguanil

M5717 200 mg DRUG

Participants received single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition

Cohort 2: M5717 (200 mg) + Pyronaridine

M5717 660mg DRUG

Participants received single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition

Cohort 3: M5717 (660 mg)+ Pyronaridine

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants with Asymptomatic Plasmodium falciparum Malaria with no Fever or other sign of Acute Uncomplicated Malaria and, with Microscopic confirmation using Giemsa-stained thick film, and a Parasitemia of \>= 40 to \<= 10,000 Asexual Parasites/Microliter (μL) of Blood.
• Axillary Temperature \< 37.0 degree Celcius (ºC) or oral/Tympanic/rectal Temperature\< 37.5ºC; without history of fever during the previous 48 hours.
• Have a body weight \>= 45 kilogram (kg)
• Participants capable of giving Signed Informed consent which includes Compliance with the requirements and restriction listed in the Informed consent form

You may not qualify if:

• Participants with any disease requiring Chronic Treatment
• Participants with any Preplanned surgery during the study
• Participants with any previous Treatment with pyronaridine as part of a combination therapy during the last 3 months
• Participants with any adequate Hematological, Hepatic, and renal function as defined in the Protocol

Sponsors & Collaborators

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

Study Sites (4)

Groupe de Recherche Action en Sante (GRAS)

Ouagadougou, Burkina Faso

Location

Kisumu County Referral Hospital

Kisumu, Kenya

Location

MRC Unit The Gambia at LSHTM

Banjul, The Gambia

Location

Ndola Teaching Hospital

Ndola, Zambia

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Malaria, Falciparum; Malaria; Asymptomatic Infections

Interventions

pyronaridine; atovaquone, proguanil drug combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 3, 2023
• Study Start: November 28, 2023
• Primary Completion: December 29, 2024
• Study Completion: December 29, 2024
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

Locations

KE (1); TH (1); BU (1); ZA (1)