Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food
|ClinicalTrials.gov Identifier: NCT01483170|
Recruitment Status : Terminated (poor tolerability at highest dose)
First Posted : December 1, 2011
Last Update Posted : March 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Trypanosomiasis, African||Drug: Tablets Fexinidazole Drug: Placebo||Phase 1|
Primary Objectives: To assess safety and tolerability of two different fexinidazole dosing regimen, for 10 days repeated administration under fed conditions in healthy male sub-Saharan volunteers.
Secondary objectives: To validate the exposure to fexinidazole, M1 and M2 after different dosing regimens in fed conditions for 10 days in order to evaluate the more appropriate administration regimen for the pivotal phase II/III study.
Two dose regimens consisting of repeated oral ascending dose (OAD) dosing in fed condition with two different ascending loading doses for 4 days followed by the same dose for 6 days will be evaluated. The study will be conducted in double-blind conditions for both the clinical and bioanalytical parts.
For each dosing regimen, subjects will reside at the clinical unit from the evening of Day -2 to the afternoon of Day 17 including an 8 days safety follow up (168 h post last dose).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blind, Placebo Controlled, Randomized Multiple Ascending Dose Study in Fed Conditions for Ten Days Dosing Regimen With a Loading Dose to Evaluate the Safety, the Tolerability and the Pharmacokinetics of Oral Fexinidazole in 36 Healthy Male Sub-Saharan Volunteers.|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||February 2012|
Drug: Tablets Fexinidazole
Administration of 3 or 4 tablets of 600mg per day during 4 days (loading dose) then administration of 2 tablets of 600mg for 6 days Dosing in fed condition.
|Placebo Comparator: Placebo fexinidazole||
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483170
|SGS Life Sciences|
|Paris, France, 75015|
|Principal Investigator:||Lionel Hovsepian, MD||SGS Aster|