deltatrials
Completed INTERVENTIONAL NCT02362516

Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809

Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers

Sponsor: Boehringer Ingelheim

Conditions Healthy
Interventions BI 425809
Updated 8 times since 2017 Last updated: Apr 13, 2026 Started: Feb 23, 2015 Primary completion: Jun 19, 2015 Completion: Jun 19, 2015
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Healthy, this trial is completed. The trial is conducted by Boehringer Ingelheim and has accumulated 8 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 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 – ~Oct 2024 · 30 days · monthly snapshotCompleted~Oct 2024 – ~Sep 2025 · 11 months · monthly snapshotCompleted~Sep 2025 – ~May 2026 · 8 months · monthly snapshotCompletedMay 4, 2026 – present · 2 months · daily APICompleted

Change History

8 versions recorded
  1. May 4, 2026 — Present [daily]

    Completed

    Phase: PHASE1None

  2. Sep 2025 — May 2026 [monthly]

    Completed PHASE1

  3. Oct 2024 — Sep 2025 [monthly]

    Completed PHASE1

  4. Sep 2024 — Oct 2024 [monthly]

    Completed PHASE1

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

Show 3 earlier versions
  1. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  3. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE1

    First recorded

Feb 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.

Contact Information

Sponsor contact:
  • Boehringer Ingelheim
Data source: ClinicalTrials.gov

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

Study Locations