deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT03334838

Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study

Open-label, Randomized, Single-dose, Cross-over Study to Evaluate the Influence of Dietary Habits on the Pharmacokinetics, Safety, and Tolerability of a 120 mg Dose and to Assess the Relative Bioavailability of a 240 mg Dose of Nifurtimox Tablets Administered to Adult Male and Female Patients With Chagas' Disease

Sponsor: Bayer

Conditions Chagas' Disease
Interventions Nifurtimox (Lampit, BAYA2502)
Updated 26 times since 2017 Last updated: Dec 29, 2020 Started: Jun 10, 2019 Primary completion: Nov 7, 2019 Completion: Jan 29, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03334838, this PHASE1 trial focuses on Chagas' Disease and remains completed. Sponsored by Bayer, it has been updated 26 times since 2019, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

26 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. Mar 2020 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  5. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE1

▶ Show 21 earlier versions

  1. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  2. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE1

  3. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE1

  4. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE1

  5. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE1

  6. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE1

  7. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE1

    Status: Not Yet Recruiting → Recruiting

  8. Jun 2019 — Jul 2019 [monthly]

    Not Yet Recruiting PHASE1

  9. May 2019 — Jun 2019 [monthly]

    Not Yet Recruiting PHASE1

  10. Apr 2019 — May 2019 [monthly]

    Not Yet Recruiting PHASE1

  11. Mar 2019 — Apr 2019 [monthly]

    Not Yet Recruiting PHASE1

  12. Feb 2019 — Mar 2019 [monthly]

    Not Yet Recruiting PHASE1

  13. Jan 2019 — Feb 2019 [monthly]

    Not Yet Recruiting PHASE1

  14. Dec 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE1

  15. Nov 2018 — Dec 2018 [monthly]

    Not Yet Recruiting PHASE1

  16. Oct 2018 — Nov 2018 [monthly]

    Not Yet Recruiting PHASE1

  17. Sep 2018 — Oct 2018 [monthly]

    Not Yet Recruiting PHASE1

  18. Aug 2018 — Sep 2018 [monthly]

    Not Yet Recruiting PHASE1

  19. Jul 2018 — Aug 2018 [monthly]

    Not Yet Recruiting PHASE1

  20. Jun 2018 — Jul 2018 [monthly]

    Not Yet Recruiting PHASE1

  21. Dec 2017 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bayer
Data source: Bayer

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

Study Locations