This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.
The present study is designed to obtain safety, tolerability and PK data after single oral administration of increasing doses of SCYX-7158 in healthy male sub-Saharan African subjects. This study will also assess the impact on the relative bioavailability of SCYX-7158 administered as a capsule after single oral dose administration. The study will be divided in 3 different parts. Study Part I will be a randomized, double-blind, placebo-controlled, single ascending dose study with SCYX-7158 administered as a capsule. A other part is scheduled to evaluate the impact of activated charcoal intake on the PK characteristics of SCYX-7158 and determine the most adapted treatment schedule for charcoal to enhance SCYX-7158 elimination while allowing a sustained drug exposure likely to be therapeutically active. A last part is planned to evaluate the pharmacokinetics of a new formulation (tablet) of SCYX-7158 in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
136
Optimed
Grenoble, France
SGS Aster
Paris, France
Occurence of adverse events (AEs)
Monitoring for the occurrence of AEs. Changes in physical examination, vital signs (blood pressure and pulse rate), ECG, and clinical laboratory tests (biochemistry, hematology, and urinalysis).
Time frame: 9 to 37 days, depending on the part of the study
Pharmacokinetic (blood concentration of SCYX-7158 and metabolite)
Time frame: from pre-dose until 168 h post-dose.
Pharmacokinetic (urine concentration of SCYX-7158 and metabolite)
Time frame: from pre-dose until 168 h post-dose.
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