Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP

Phase 1 Completed 24 enrolled Medicines for Malaria Venture Clinical Network Services (CNS) Pty Ltd · collab Q-Pharm Pty Limited · collab QIMR Berghofer Medical Research Institute · collab

RandomizedParallel-groupOpen-labelOther

Summary

A single-centre Phase 1b study to assess the safety, tolerability, pharmacokinetic profile, and antimalarial activity of single doses of coadministered artefenomel (OZ439) and piperaquine phosphate (PQP) against early Plasmodium falciparum blood stage infection in healthy adult volunteers.

Timeline

Start: 2018-04-23
Primary completion: 2019-04-19
Completion: 2019-04-19

Publications

Abd-Rahman AN, Kaschek D, Kummel A, Webster R, Potter AJ, Odedra A, Woolley SD, Llewellyn S, Webb L, Marquart L, Chalon S, Gaaloul ME, McCarthy JS, Mohrle JJ, Barber BE. Characterizing the pharmacological interaction of the antimalarial combination artefenomel-piperaquine in healthy volunteers with induced blood-stage Plasmodium falciparum to predict efficacy in patients with malaria. BMC Med. 2024 Nov 28;22(1):563. doi: 10.1186/s12916-024-03787-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artefenomel	Small molecule	200 mg	Oral
Subject	Artefenomel	Small molecule	400 mg	Oral
Subject	Artefenomel	Small molecule	800 mg	Oral
Subject	piperaquine	Small molecule	320 mg	Oral
Subject	piperaquine	Small molecule	480 mg	Oral
Subject	piperaquine	Small molecule	640 mg	Oral
Subject	piperaquine	Small molecule	960 mg	Oral

Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP

Summary

Timeline

Publications

Drugs

Indications