Status:

TERMINATED

A Study in Healthy Men to Find Out How Different Doses of BI 3009947 Are Tolerated and How Different Formulations or Food Influence How BI 3009947 is Taken up Into the Blood

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Healthy

Eligibility:

MALE

18-45 years

Phase:

PHASE1

Brief Summary

Single-rising dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following ora...

Eligibility Criteria

Inclusion Criteria:

  1. Healthy male trial participant 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-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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
  5. Further exclusion criteria apply.

Key Trial Info

Start Date :

November 21 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 2 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT07250048

Start Date

November 21 2025

End Date

March 2 2026

Last Update

April 1 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Humanpharmakologisches Zentrum Biberach

Biberach, Germany, 88397