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

NCT06861829 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 1519-00042024-517895-39-00U1111-1314-3696
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.

  Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

• Maximum Measured Concentration of BI 3731579 in Plasma (Cmax)

  Maximum measured concentration of BI 3731579 in plasma (Cmax) is presented.

  Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

Study Arms (2)

BI 3731579 fasted - fed (R-T)

EXPERIMENTAL

Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.

Drug: BI 3731579

BI 3731579 fed - fasted (T-R)

EXPERIMENTAL

Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.

Drug: BI 3731579

Interventions

BI 3731579 DRUG

BI 3731579

BI 3731579 fasted - fed (R-T); BI 3731579 fed - fasted (T-R)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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 Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal 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 outside the range of 45 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 6, 2025
• Study Start: March 19, 2025
• Primary Completion: April 17, 2025
• Study Completion: April 23, 2025
• Last Updated: August 11, 2026
• Results First Posted: August 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)