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 ]

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).


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