Who is sponsoring NCT02783833?

NCT02783833 is sponsored by Medicines for Malaria Venture.

What drugs are being tested in NCT02783833?

Interventions: MMV390048 40mg, MMV390048 dose to be determined mg.

What is the status of NCT02783833?

NCT02783833 is currently COMPLETED.

Last reviewed 2017-02-07 · How we verify

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

NCT02783833 Phase 1/Phase 2 COMPLETED

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).

Details

Lead sponsor	Medicines for Malaria Venture
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	15
Start date	2016-05
Completion	2017-01-16

Conditions

Malaria

Interventions

MMV390048 40mg
MMV390048 dose to be determined mg

Primary outcomes

Effect on parasites — 28 days
The effect of a single oral dose of MMV390048 on P. falciparum blood stage parasites in healthy volunteers with induced blood stage malaria as observed over a period of 28 days post dosing, through: * qPCR analysis of parasite clearance, and * calculation of the parasite reduction ratio (PRR)

Countries

Australia