deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT05543369

Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants

A Phase I, Single-Centre, Open-Label, Repeat Dose Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of Elafibranor in Healthy Japanese and Non-Asian Participants.

Sponsor: Ipsen

Interventions Elafibranor
Updated 10 times since 2022 Last updated: Feb 18, 2025 Started: Sep 19, 2022 Primary completion: Mar 10, 2023 Completion: Mar 10, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05543369, this PHASE1 trial focuses on Healthy Volunteers and remains completed. Sponsored by Ipsen, it has been updated 10 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshotNot Yet Recruiting~Nov 2022 – ~Feb 2023 · 3 months · monthly snapshotRecruiting~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshotRecruiting~Mar 2023 – ~Jun 2023 · 3 months · monthly snapshotRecruiting~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshotCompleted~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshotCompleted~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshotCompleted~Mar 2025 – present · 16 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Mar 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Mar 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jul 2023 — Aug 2023 [monthly]

    Completed PHASE1

Show 5 earlier versions
  1. Jun 2023 — Jul 2023 [monthly]

    Completed PHASE1

    Status: RecruitingCompleted

  2. Mar 2023 — Jun 2023 [monthly]

    Recruiting PHASE1

  3. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE1

  4. Nov 2022 — Feb 2023 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  5. Sep 2022 — Nov 2022 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ipsen
Data source: Ipsen

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