Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-blind, Placebo-controlled Study of the Tolerability, and Pharmacokinetics of Fexinidazole After Single and Repeated Oral Ascending Doses, Completed by a Comparative Bioavailability Study of an Oral Suspension Versus a Tablet and an Exploratory Assessment of Food Effect, in Healthy Male Volunteers|
- Occurence of adverse events (AEs) [ Time Frame: 8 to 37 days, depending on the part of the study ] [ Designated as safety issue: Yes ]
- Pharmacokinetic : measure of blood and urine concentration of fexinidazole, fexinidazole sulfoxide and fexinidazole sulfone in order to determine AUC0-t and Cmax values, for all dose levels [ Time Frame: pre-dose, and 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 48, 72, 96, 120, 144 and 168 h post-dose ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Experimental: Fexinidazole||Drug: Fexinidazole/Placebo|
|Placebo Comparator: Placebo||Drug: Fexinidazole/Placebo|
The present study is designed to obtain safety, tolerability and PK data after single and multiple oral administration of increasing doses of fexinidazole in healthy male sub-Saharan African subjects. This study will also assess the relative bioavailability of fexinidazole administered as a tablet in comparison with oral suspension, and to assess the impact of concomitant food intake on the relative bioavailability of fexinidazole 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 fexinidazole administered as an oral suspension.
Study Part II will be a comparative bioavailability study of a fexinidazole tablet vs. the oral suspension and assessment of food effect, according to a three-way cross-over design. 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 fexinidazole administered either as an oral suspension or as a tablet, depending on Part II results. 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 metabolites. Treatment duration will be 14 days.
Bioanalysis will be performed in open conditions for Study Part I and Study Part III.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982904
|Paris, France, 75015|
|Principal Investigator:||Lionel Hovsepian, MD||SGS Aster|
|Study Chair:||Nathalie Strub-Wourgaft, MD||Drugs for Neglected Diseases initiative|