NCT02783833

MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part B

A Single Centre, Two-part, Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P. falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P. falciparum (Part B).

Detailed description

Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P. falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P. falciparum (Part B). An approximation of this concentration in healthy subjects will help to identify the optimal dose of MMV390048 for subsequent Phase 2 studies in patients. The challenge model will enable characterization of the exposure-response relationship for MMV390048 and will also provide data regarding the safety and tolerability of MMV390048 in a controlled disease-like setting.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	MMV390048 40mg
DRUG	MMV390048 dose to be determined mg	Cohort 2 will receive a single dose of MMV390048. Depending on the data obtained from the 40mg cohort, the dose in Cohort 2 will be determined.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-01-16
• Completion: 2017-01-16
• First posted: 2016-05-26
• Last updated: 2017-02-08

Locations

1 site across 1 country: Australia