Trypanosomiasis, African Clinical Trial
Official title:
A Bioequivalence Study of the Reference Clinical Fexinidazole Tablet vs Proposed Market Formulation in Healthy Male Volunteers of African Sub-Saharan Origin:an Open-label,Randomized,Two-treatment,Single Dose,Replicate Design,Fed Condition
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of
the tablet formulation used in the clinical trials and the final marketed tablet formulation
under fed condition.
The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate
crossover study under fed condition. The 4-period sequences for the replicate design will be
TRTR and RTRT, where R designates the reference formulation and T the test formulation.
Subject will be allocated randomly to one of the two sequences of treatments according to
the randomization list.
Ideally, BE study should be conducted under fasting condition as this is considered to be
the most sensitive condition to detect a potential difference between formulations. However
as fexinidazole is recommended to be taken with food, as food increased the plasma
concentration by 2.5 to 3 fold compared to plasma. BE will be conducted under fed condition,
using field adapted meal. The wash-out period should be sufficient to ensure that drug
concentrations are below the limit of quantification in all the subjects at the beginning of
the next period, a 2 weeks wash-out period will be used. The intra-subject variability of
fexinidazole was evaluated based on a previous 3-period cross-over study (1) and was
estimated at 25%. As this value was quite high and close to 30%, a replicate design was
chosen.
Primary objective:
To assess BE of the clinical trial 600 mg tablet formulation versus (vs.) the proposed
market 600 mg tablet formulation of fexinidazole under fed condition after single oral
administration of 1200 mg.
Secondary objectives:
To assess the pharmacokinetic profile of the two metabolites fexinidazole sulfoxide and
fexinidazole sulfone under the fed condition. To assess the safety and tolerability in
healthy volunteers under the same study conditions.
Meal: On each treatment period, fexinidazole will be given with concomitant meal which
composition will be as close as possible to field condition
sample size: In order to have 24 evaluable subjects a total of 30 subjects will be recruited
in the study.
Study Treatment: Single oral dose of 1200 mg / period :
- Treatment R: Reference formulation, i.e. 2 × 600 mg clinical tablets
- Treatment T: Test formulation, i.e. 2 × 600 mg proposed market tablets
Pharmacokinetic sampling: Pre-dose, and 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120 and 168
h post-dose Total blood drawn: 390 mL ( Pharmacokinetic = 240 mL + safety = 150 mL)
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01483170 -
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
|
Phase 1 | |
Terminated |
NCT00489658 -
Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda
|
Phase 2/Phase 3 | |
Completed |
NCT03087955 -
Prospective Study on Efficacy and Safety of Acoziborole (SCYX-7158) in Patients Infected by Human African Trypanosomiasis Due to T.b. Gambiense
|
Phase 2/Phase 3 | |
Completed |
NCT03025789 -
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
|
Phase 3 | |
Terminated |
NCT00330148 -
Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis
|
Phase 3 | |
Recruiting |
NCT05433350 -
Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients
|
Phase 2/Phase 3 | |
Withdrawn |
NCT05645822 -
Screen and Treat Implementation for HAT Control
|
||
Completed |
NCT05947604 -
DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan
|
Phase 1 | |
Completed |
NCT01533961 -
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
|
Phase 1 | |
Completed |
NCT05256017 -
Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects
|
Phase 2/Phase 3 | |
Completed |
NCT00802594 -
A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
|
Phase 2 | |
Completed |
NCT00146627 -
Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
|
Phase 3 |