MedTrace Logo

Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole

NCT00982904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-04-06

No results posted yet for this study

Summary

This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows highly promising efficacy.

Conditions

  • Human African Trypanosomiasis

Interventions

DRUG

Fexinidazole/Placebo

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Lionel Hovsepian, MD · SGS Aster

  • Nathalie Strub-Wourgaft, MD · Drugs for Neglected Diseases initiative

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2010-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00982904 on ClinicalTrials.gov