Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
|ClinicalTrials.gov Identifier: NCT01533961|
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : September 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Trypanosomiasis Trypanosomiasis, African Protozoan Infections Parasitic Diseases||Drug: SCYX-7158 Drug: Placebo||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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
- 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).
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533961
|Study Director:||Antoine Tarral, MD||Drugs for Neglected Diseases initiative|