Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection

Phase 2 Completed 82 enrolled Medicines for Malaria Venture Mahidol University · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in adult patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection.

Timeline

Start: 2010-10
Primary completion: 2012-05
Completion: 2012-05

Publications

Phyo AP, Jittamala P, Nosten FH, Pukrittayakamee S, Imwong M, White NJ, Duparc S, Macintyre F, Baker M, Mohrle JJ. Antimalarial activity of artefenomel (OZ439), a novel synthetic antimalarial endoperoxide, in patients with Plasmodium falciparum and Plasmodium vivax malaria: an open-label phase 2 trial. Lancet Infect Dis. 2016 Jan;16(1):61-69. doi: 10.1016/S1473-3099(15)00320-5. Epub 2015 Oct 5.

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	Artefenomel	Small molecule	1200 mg	Oral

Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection

Summary

Timeline

Publications

Drugs

Indications