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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 3731579

Study type: Interventional

Funder types: Industry

Identifiers

NCT06861829

2024-517895-39-00 (Registry Identifier)

U1111-1314-3696 (Registry Identifier)

1519-0004

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Treatment sequence A (R-T)

Experimental group

Description:

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

Treatment:

Drug: BI 3731579

Treatment sequence B (T-R)

Experimental group

Description:

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

Treatment:

Drug: BI 3731579