A Study in Healthy Men to Test How BI 1584862 is Processed in the Body

Boehringer Ingelheim

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862; Drug: [13C]-labeled BI 1584862

Study type: Interventional

Funder types: Industry

Identifiers

NCT07336758

2025-522311-41-00 (Registry Identifier)

U1111-1322-4722 (Registry Identifier)

1484-0017

Details and patient eligibility

About

The goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). The study will measure how much of the study medicine is recovered in urine and faeces after taking it by mouth. It will also look at how much of the study medicine enters the bloodstream when taken by mouth compared to a small dose given directly into the bloodstream. The study staff measures the amount of BI 1584862 and its broken-down parts in the blood, the urine, and the stool.

Enrollment: 8 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male trial participant 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
2. Age of 18 to 55 years (inclusive) at screening
3. BMI of 18.5 to 29.9 kg / m2 (inclusive) at screening
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment)

Experimental group

Treatment:

Drug: Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862

Drug: [13C]-labeled BI 1584862