Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
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|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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533961
|Study Director:||Antoine Tarral, MD||Drugs for Neglected Diseases initiative|