Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
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, Food Effect and Multiple Oral Ascending Dose 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|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Experimental: SCYX-7158||Drug: SCYX-7158|
|Placebo Comparator: Placebo of SCYX-7158||Drug: Placebo|
The present study is designed to obtain safety, tolerability and PK data after single and multiple oral administration of increasing doses of SCYX-7158 in healthy male sub-Saharan African subjects. This study will also assess the impact of concomitant food intake on the relative bioavailability of SCYX-7158 administered as a capsule after single oral dose administration.
The study will be divided in 3 successive parts. Study Part I will be a randomized, double-blind, placebo-controlled, single ascending dose study with SCYX-7158 administered as a capsule.
Study Part II will be a comparative bioavailability study of SCYX-7158 capsule administered in fasting or fed condition (assessment of food effect), according to a two-way cross-over design (or three ways depending on results). Clinical part will be conducted in open conditions and bioanalysis in blind conditions.
Study Part III will be a randomized, double-blind, placebo-controlled, multiple ascending dose study with SCYX-7158 administered as a capsule. Dosage regimen will be either q.d. or b.i.d., depending on Part I and Part II results for the unchanged drug and the metabolite. Treatment duration will be 15 days, including placebo on day-1.
Bioanalysis will be performed in open conditions for Study Part I and Study Part III.
|Contact: Antoine Tarral, MDfirstname.lastname@example.org|
|Contact: Séverine Blesson, MScemail@example.com|
|Contact: Lionel Hovsepian, MD|
|Principal Investigator: Lionel Hovsepian, MD|
|Study Director:||Antoine Tarral, MD||Drugs for Neglected Diseases initiative|