Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria

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.

Timeline

Start

2018-09-11

Primary completion

2019-11-06

Completion

2019-11-06

Publications

• Gansane A, Lingani M, Yeka A, Nahum A, Bouyou-Akotet M, Mombo-Ngoma G, Kaguthi G, Barcelo C, Laurijssens B, Cantalloube C, Macintyre F, Djeriou E, Jessel A, Bejuit R, Demarest H, Marrast AC, Debe S, Tinto H, Kibuuka A, Nahum D, Mawili-Mboumba DP, Zoleko-Manego R, Mugenya I, Olewe F, Duparc S, Ogutu B. Randomized, open-label, phase 2a study to evaluate the contribution of artefenomel to the clinical and parasiticidal activity of artefenomel plus ferroquine in African patients with uncomplicated Plasmodium falciparum malaria. Malar J. 2023 Jan 3;22(1):2. doi: 10.1186/s12936-022-04420-2.

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