deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT00982904

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

Updated 6 times since 2017 Last updated: Apr 5, 2017 Started: Sep 30, 2009 Primary completion: Sep 30, 2010 Completion: Oct 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~May 2017 · 4 months · monthly snapshotCompleted~May 2017 – ~Jun 2018 · 13 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 21 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  5. May 2017 — Jun 2018 [monthly]

    Completed PHASE1

Show 1 earlier version
  1. 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

Sponsor contact:
  • Drugs for Neglected Diseases
  • Sanofi
Data source: Drugs for Neglected Diseases

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations