At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Exploratory Study to Evaluate the Pharmacokinetics of Selected Oral Formulations of MMV390048 Administered in the Fasted State to Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating MMV390048 formulation A and MMV390048 formulation B for Malaria. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This study will be conducted in a single centre, as an open single dose two parallel cohorts design with oral doses of MMV390048 administered in healthy male and female subjects between 18 to 55 years of age. Subjects will be screened within 28 days prior to entering the study. On Day 1 of the study each subject will receive one of the two MMV390048 prototype formulations, at a dose of 40 mg with 240 mL of water. Subjects will be discharged on Day 3 after 48h post-dose and they will attend the unit for follow-up visits on Days 5, 7, 10, 14, 19, 26 and 29.
Study Details
Timeline
Interventions
MMV390048 formulation A, tablet
MMV390048 formulation B, tablet