A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated

Last updated: June 10, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

BI 3731579

Matching placebo to BI 3731579

Clinical Study ID

NCT06429137
1519-0001
U1111-1304-0523
2023-510318-25-00
  • Ages 18-45
  • Male
  • Accepts Healthy Volunteers

Study Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.

Eligibility Criteria

Inclusion

Inclusion criteria

  1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

  2. Age of 18 to 45 years (inclusive)

  3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)

  4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria

  1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

  2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)

  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

  4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply

Study Design

Total Participants: 63
Treatment Group(s): 2
Primary Treatment: BI 3731579
Phase: 1
Study Start date:
July 08, 2024
Estimated Completion Date:
May 27, 2025

Connect with a study center

  • Humanpharmakologisches Zentrum Biberach

    Biberach, 88397
    Germany

    Site Not Available

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