Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole
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
Sponsor: Drugs for Neglected Diseases
Listed as NCT00982904, this PHASE1 trial focuses on Human African Trypanosomiasis and remains completed. Sponsored by Drugs for Neglected Diseases, it has been updated 6 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
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May 2017 — Jun 2018 [monthly]
Completed PHASE1
▶ Show 1 earlier version
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Jan 2017 — May 2017 [monthly]
Completed PHASE1
First recorded
Sep 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Drugs for Neglected Diseases
- Sanofi
For direct contact, visit the study record on ClinicalTrials.gov .