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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 3731579

• Registration Number: NCT06861829
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-06
• Study Start: 2025-03-19
• Status Verified: 2025-04
• Primary Completion: 2025-04-17
• Study Completion: 2025-04-23
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence A (R-T)	BI 3731579	first fasting state (reference (R)), then fed state (test (T))
Treatment sequence B (T-R)	BI 3731579	first fed state (test (T)), then fasting state (reference (R))

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany