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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-03-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

[13C]-labeled BI 1584862

Intervention Type DRUG

\[13C\]-labeled BI 1584862, Reference treatment

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

Intervention Type DRUG

BI 1584862 (C-14), Test treatment

Interventions

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[13C]-labeled BI 1584862

\[13C\]-labeled BI 1584862, Reference treatment

Intervention Type DRUG

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

BI 1584862 (C-14), Test treatment

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes