deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT04426851

A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood

Investigation of Pharmacokinetics and Absolute Bioavailability of BI 1358894 Administered Orally as Tablet Co-administered With an Intravenous Microtracer Dose of [C-14]-BI 1358894 in Healthy Male Volunteers Via a Non-randomised, Open-label, Fixed-sequence Trial (Part 1) Followed by a Randomised, Open-label, Single-dose, Two-period, Two-sequence Cross-over Relative Bioavailability Trial in BI 1358894 Oral Suspension (Part 2)

Sponsor: Boehringer Ingelheim

Conditions Healthy
Updated 9 times since 2020 Last updated: Mar 13, 2025 Started: Jul 13, 2020 Primary completion: Oct 12, 2020 Completion: Oct 12, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Healthy and is currently completed. Boehringer Ingelheim leads this study, which shows 9 recorded versions since 2020 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshotNot Yet Recruiting~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshotRecruiting~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshotRecruiting~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshotActive Not Recruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshotCompleted~Apr 2025 – present · 15 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Apr 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Apr 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Nov 2020 — Jan 2021 [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

Show 4 earlier versions
  1. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  2. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE1

  3. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  4. Jul 2020 — Aug 2020 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boehringer Ingelheim
Data source: Boehringer Ingelheim

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

Study Locations