NCT03660839

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 14 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The duration of the study was up to 32 days, including up to 1 day screening period before the single-dose treatment, 5 days of post-treatment surveillance (included 2 to 4 days hospitalization) and 24±2 days follow-up period.

Conditions

• Plasmodium Falciparum Infection

Interventions

Type	Name	Description
DRUG	Artefenomel (OZ439)	Pharmaceutical form: Granules for oral suspension Route of administration: Oral
DRUG	Ferroquine (SSR97193)	Pharmaceutical form: Capsule Route of administration: Oral

Timeline

• Start date: 2018-09-11
• Primary completion: 2019-11-06
• Completion: 2019-11-06
• First posted: 2018-09-07
• Last updated: 2022-03-21
• Results posted: 2020-12-02

Locations

7 sites across 5 countries: Benin, Burkina Faso, Gabon, Kenya, Uganda

Regulatory

• FDA-regulated drug study