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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Malaria Infection

Treatments: Drug: M5717 200 mg; Drug: Atovaquone-Proguanil; Drug: M5717 660mg; Drug: Pyronaridine; Drug: M5717 60 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05974267

MS201618_0034

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Other Protocol defined Inclusion Criteria could apply

Exclusion criteria

• 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
• Other protocol defined Exclusion Criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 4 patient groups

Cohort 1: M5717 (60 mg) + Pyronaridine

Experimental group

Description:

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.

Treatment:

Drug: Pyronaridine

Drug: M5717 60 mg

Cohort 2: M5717 (200 mg) + Pyronaridine

Experimental group

Description:

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.

Treatment:

Drug: Pyronaridine

Drug: M5717 200 mg

Cohort 3: M5717 (660 mg)+ Pyronaridine

Experimental group

Description:

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.

Treatment:

Drug: M5717 660mg

Drug: Pyronaridine

Cohort 4: Atovaquone-proguanil

Experimental group

Description:

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

Treatment:

Drug: Atovaquone-Proguanil