NCT04002687

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

A Randomized, Double-blind, Placebo Controlled Parallel Group Study in Heathy Adult Subjects to Determine the Tolerability and Safety of Atovaquone-proguanil (ATV-PG) Co-administered With Amodiaquine (AQ)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Although the tolerability and safety of ATV-PG and AQ alone are well established, additive tolerability signals are possible on co-administration. Four treatment arms will be used: ATV-PG + AQ placebo, ATV-PG placebo + AQ, ATV-PG placebo + AQ placebo, as well as ATV-PG + AQ. This will facilitate discrimination of the contribution of the treatments to any tolerability signal. In the event that ATV-PG + AQ is not considered sufficiently well tolerated, data on the individual agents will provide an indication of whether ATV-PG or AQ are suitable partner drugs for other combinations. Thus, this study will evaluate in healthy adults, whether the tolerability and safety profile of once daily administration of ATV-PG + AQ for 3 days supports future use in Seasonal Malaria Chemoprevention (SMC), which will entail administration on a monthly basis to an apparently healthy population of children of 3 months of age and older, for the duration of the malaria season. This study will also determine the pharmacokinetics of ATV, PG, CG (active metabolite of PG), AQ and DEAQ (active metabolite of AQ). Given the ultimate target population (children in Southern and Easter Africa in areas in which SMC with SPAQ is not currently deployed due to SP resistance), the study will be carried out in healthy subjects of sub-Saharan African origin (defined as subjects whose parents were both born in sub-Saharan Africa).

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	ATV-PG 1000-400 mg + AQ 612 mg	The dosing will be carried out by an unblinded member of the investigator's staff. Dosing will take place behind a curtain and during IMP administration the subjects will be blindfolded. ATV-PG (or placebo) will always be given first, then AQ (or placebo).

Timeline

• Start date: 2019-04-04
• Primary completion: 2019-10-29
• Completion: 2019-10-29
• First posted: 2019-06-28
• Last updated: 2020-03-19

Locations

1 site across 1 country: United Kingdom