drugset / Trial / NCT04002687

Determine the Tolerability and Safety of Atovaquone-proguanil (ATV-PG) Co-administered With Amodiaquine (AQ)

NCT04002687

RandomizedFactorialQuadruple-blindPrevention

Summary

The aim of the study is to determine the tolerability and safety of ATV-PG + AQ, ATV-PG + AQ placebo, ATV-PG placebo + AQ, and ATV-PG placebo + AQ placebo administered once daily for 3 days to healthy adult male and female subjects.This study in healthy adults is the first step towards establishing the tolerability and safety of the approved doses of ATV-PG and AQ when co-administered. If considered acceptable based on the findings of this study, the tolerability, safety and PE will subsequently be assessed, within the target geographical areas.

Timeline

Start
2019-04-04
Primary completion
2019-10-29
Completion
2019-10-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Atovaquone Small molecule 1000 mg
Subject Proguanil Small molecule 400 mg
Subject amodiaquine Other / unclassified 612 mg

Indications