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

NCT07336758 | Completed Phase 1

• 3 other identifiers: 1484-00172025-522311-41-00U1111-1322-4722
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Cmax (maximum measured concentration of the analyte in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)

  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)

  Up to Day 13

• Cmax of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)

  Up to Day 13

• AUC0-tz of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)

  Up to Day 13

• Cmax of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)

  Up to Day 6

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

BI 1584862 (C-14), Test treatment

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

[13C]-labeled BI 1584862 DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age of 18 to 55 years (inclusive) at screening
• BMI of 18.5 to 29.9 kg / m2 (inclusive) at screening
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

ICON-Groningen-62040

Groningen, 9728 NZ, Netherlands

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: January 22, 2026
• Primary Completion: March 4, 2026
• Study Completion: March 4, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)