At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2a Proof-of-Concept, Multicenter, Randomized, Open Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of the Combination M5717-pyronaridine as Chemoprevention in Asymptomatic Adults and Adolescents With Plasmodium Falciparum Malaria Infection (CAPTURE-2)
In Brief
A Phase 2 clinical trial evaluating M5717 60 mg, Pyronaridine, and 3 other interventions for Malaria Infection. Completed, enrolled 192 participants across 4 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants received single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition
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
Participants received Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.
Participants received single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition
Participants received single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition