A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood

Last updated: April 28, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

BI 3731579

Clinical Study ID

NCT06861829
1519-0004
U1111-1314-3696
2024-517895-39-00
  • Ages 18-50
  • Male
  • Accepts Healthy Volunteers

Study Summary

This trial investigates whether food influences the amount of BI 3731579 in the blood.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Healthy male subjects according to the assessment of the investigator, as based on acomplete medical history including a physical examination, vital signs (bloodpressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinicallaboratory tests

  • Age of 18 to 50 years (inclusive)

  • Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (inclusive)

  • Signed and dated written informed consent in accordance with International Councilfor Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission to the trial

Exclusion

Exclusion criteria:

  • Any finding in the medical examination (including BP, PR or ECG) deviating fromnormal and assessed as clinically relevant by the investigator

  • 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 outsidethe range of 45 to 90 bpm

  • Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance

  • Any evidence of a concomitant disease assessed as clinically relevant by theinvestigator Further exclusion criteria apply.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: BI 3731579
Phase: 1
Study Start date:
March 19, 2025
Estimated Completion Date:
April 23, 2025

Connect with a study center

  • Humanpharmakologisches Zentrum Biberach

    Biberach, 88397
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.