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Artefenomel

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

Ensayo de Sanofi en Plasmodium Falciparum Infection (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

140

previstos

Centros

7

Fin del objetivo primario

nov 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2018.

Qué mide

Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) (del registro, en inglés) (dia 28)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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.

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Ficha completa en ClinicalTrials.gov (NCT03660839), actualizada en mar 2022.