drugset / Trial / NCT00563914

A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria

NCT00563914

Phase 1/2 Completed 72 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective is to assess the safety of different doses of ferroquine with artesunate (AS) in adult African patients with uncomplicated malaria. The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.

Timeline

Start
2007-10
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferroquine Small molecule 100 mg
Subject Ferroquine Small molecule 200 mg
Subject Ferroquine Small molecule 400 mg
Subject Ferroquine Small molecule 600 mg
Comparator amodiaquine Other / unclassified 612 mg
Background Artesunate Small molecule 200 mg

Indications