Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Occurence of adverse events (AEs) [ Time Frame: 9 to 37 days, depending on the part of the study ] [ Designated as safety issue: Yes ]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).
- Pharmacokinetic (blood concentration of SCYX-7158 and metabolite) [ Time Frame: from pre-dose until 168 h post-dose. ] [ Designated as safety issue: No ]
- Pharmacokinetic (urine concentration of SCYX-7158 and metabolite) [ Time Frame: from pre-dose until 168 h post-dose. ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
In each dose group (8 subjects) , 6 Healthy Volunteers receive SCYX-7158
Placebo Comparator: Placebo of SCYX-7158
In each dose group (8 subjects) , 2 Healthy Volunteers receive placebo of SCYX-7158
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533961
|Study Director:||Antoine Tarral, MD||Drugs for Neglected Diseases initiative|