Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A

Summary

This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).

Timeline

Start

2016-05

Primary completion

2016-12

Completion

2016-12

Publications

• McCarthy JS, Donini C, Chalon S, Woodford J, Marquart L, Collins KA, Rozenberg FD, Fidock DA, Cherkaoui-Rbati MH, Gobeau N, Mohrle JJ. A Phase 1, Placebo-controlled, Randomized, Single Ascending Dose Study and a Volunteer Infection Study to Characterize the Safety, Pharmacokinetics, and Antimalarial Activity of the Plasmodium Phosphatidylinositol 4-Kinase Inhibitor MMV390048. Clin Infect Dis. 2020 Dec 17;71(10):e657-e664. doi: 10.1093/cid/ciaa368.

Drugs

Indications