NCT04866602

Atoguanil BA Study

A Randomised, Open Label 2-period Crossover Study to Evaluate the Relative Bioavailability of Atoguanil Compared to Malarone® in Healthy Adult Participants in the Fed State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure from Atoguanil in comparison to Malarone®.

Detailed description

After being informed about the study and potential risks, all adult participants giving written informed consent will be screened within 30 days prior to entering the trial on Day -1 to determine eligibility for study entry. The trial will establish whether the PK profile of both atovaquone (ATV), proguanil (PG) and cycloguanil (CG) from Atoguanil is similar to Malarone® and whether exposure of ATV from Atoguanil indicates that at least a 2-fold reduction in ATV dose compared with Malarone® is feasible (i.e. that the bioavailability of ATV in Atoguanil is approximately double that of ATV in Malarone®).

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	Atoguanil	Atovaquone + Proguanil free base:125 mg: 87 mg, 4 tablets
DRUG	Malarone	Atovaquone + Proguanil HCl: 250 mg: 100 mg, 4 tablets

Timeline

• Start date: 2021-11-17
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2021-04-30
• Last updated: 2022-05-05

Locations

1 site across 1 country: United Kingdom