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

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Treatments: Atovaquone; Atovaquone, proguanil drug combination; Proguanil; Pyronaridine

Criteria

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