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

NCT03660839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-03-21

Study results available
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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.

Conditions

  • Plasmodium Falciparum Infection

Interventions

DRUG

Artefenomel (OZ439)

Pharmaceutical form: Granules for oral suspension Route of administration: Oral

DRUG

Ferroquine (SSR97193)

Pharmaceutical form: Capsule Route of administration: Oral

Sponsors & Collaborators

  • Medicines for Malaria Venture

    collaborator OTHER

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2019-11-06
Completion
2019-11-06
FDA Drug
Yes

Countries

  • Benin
  • Burkina Faso
  • Gabon
  • Kenya
  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03660839 on ClinicalTrials.gov