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

A Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Micro-tracer Dose of BI 1584862 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1584862 (C-13) in Healthy Male Trial Participants (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [13C]-labeled BI 1584862; Drug: Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • ICON-Groningen-62040

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment)	Drug: [13C]-labeled BI 1584862; [13C]-labeled BI 1584862, Reference treatment; Drug: Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862; BI 1584862 (C-14), Test treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz)	hADME part	Up to Day 14
Fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz)	hADME part	Up to Day 14
Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)	hADME part	Up to Day 14
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) (AUC0-∞)	BA part	Up to day 13
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of [13C]-BI 1584862 after a single intravenous infusion of BI 1584862 (C-13) (AUC0-∞)	BA part	Up to Day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (maximum measured concentration of the analyte in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)	hADME and BA part	Up to Day 13
AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)	hADME and BA part	Up to Day 13
Cmax of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)	hADME part	Up to Day 13
AUC0-tz of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)	hADME part	Up to Day 13
Cmax of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)	BA part	Up to Day 6
AUC0-tz of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)	BA part	Up to Day 6

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2026
• Primary Completion (Actual): March 4, 2026
• Study Completion (Actual): March 4, 2026

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: January 2, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1484-0017; 2025-522311-41-00 (Registry Identifier: CTIS); U1111-1322-4722 (Registry Identifier: WHO Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No