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

NCT06861829 | Completed Phase 1 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 the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  up to 4 days

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 4 days

Secondary Outcomes (1)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 4 days

Study Arms (2)

Treatment sequence A (R-T)

EXPERIMENTAL

first fasting state (reference (R)), then fed state (test (T))

Drug: BI 3731579

Treatment sequence B (T-R)

EXPERIMENTAL

first fed state (test (T)), then fasting state (reference (R))

Drug: BI 3731579

Interventions

BI 3731579 DRUG

BI 3731579

Treatment sequence A (R-T); Treatment sequence B (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

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: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)