OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
This study aims to investigate the concentration dependent effects of OZ439 on the clearance
of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum
inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD
(Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based
dosing. The adaptive investigation of a range of doses will provide the best chance of
accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth
dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal
concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be
confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on
parasitaemia will be investigated.