drugset / Trial / 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

NCT01483170

Phase 1 Terminated 30 enrolled Drugs for Neglected Diseases
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations. The drug is administered to human healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with a loading dose during 4 days.

Timeline

Start
2011-09
Primary completion
2011-12
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Fexinidazole Small molecule 1200 mg Oral