Trypanosomiasis, African Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Sequential Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCYX-7158 After Single Oral Ascending Doses in Healthy Male Volunteers
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
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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