Clinical Trial: Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 V
Brief Summary: 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.
Detailed Summary:
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
Sponsor: Drugs for Neglected Diseases
Current Primary Outcome: Occurence of adverse events (AEs) [ Time Frame: 9 to 37 days, depending on the part of the study ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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. ]
Original Secondary Outcome: Same as current
Information By: Drugs for Neglected Diseases
Dates:
Date Received: February 13, 2012
Date Started: February 2012
Date Completion:
Last Updated: September 17, 2015
Last Verified: February 2012