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.
The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
associated with artesunate
associated with artesunate
Sanofi-Aventis Administrative Office
Lambaréné, Gabon
Sanofi-Aventis Administrative Office
Nairobi, Kenya
Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin
Time frame: Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28
Parasite clearance assessed by repeated measurements of parasitemia
Time frame: Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28
Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration
Time frame: up to 28 days after last dosing
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