At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open Label, Parallel-group, Single Dose Regimen, Phase 2a Study, to Investigate the Clinical and Parasiticidal Activity and the Pharmacokinetics of 3 Dose Levels of Artefenomel (OZ439) Given in Combination With Ferroquine (FQ) and FQ Alone, in African Patients With Uncomplicated Plasmodium Falciparum Malaria
In Brief
A Phase 2 clinical trial evaluating Artefenomel (OZ439) and Ferroquine (SSR97193) for Plasmodium Falciparum Infection. Completed, enrolled 140 participants across 7 sites in 5 countries.
Detailed Summary
Primary Objective: To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) for the effect and the area under the curve (AUC) of OZ439 as pharmacokinetic (PK) predictor. Secondary Objectives: * To evaluate the exposure-response of OZ439 combined with FQ on crude Day 28 ACPR. * To evaluate the dose response of OZ439 combined with FQ on PCR-corrected and crude Day 28 ACPR. * To evaluate the dose-response of OZ439 combined with FQ on selected secondary endpoints. * To evaluate the safety and tolerability of different dosages of OZ439 in combination with FQ and FQ alone. * To characterize the PK of OZ439 in plasma, and of FQ and its active metabolite SSR97213 in blood.
Study Details
Timeline
Interventions
Pharmaceutical form: Granules for oral suspension Route of administration: Oral
Pharmaceutical form: Capsule Route of administration: Oral