Trials / Completed
CompletedNCT01533961
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Drugs for Neglected Diseases · Academic / Other
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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 description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SCYX-7158 | |
| DRUG | Placebo |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2012-02-16
- Last updated
- 2015-09-18
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01533961. Inclusion in this directory is not an endorsement.