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Completed

NCT Number: NCT07336758

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON-Groningen-62040

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

[13C]-labeled BI 1584862

Drug

[13C]-labeled BI 1584862, Reference treatment

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

Drug

BI 1584862 (C-14), Test treatment

Primary outcomes

  1. 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)

    Time frame: Up to Day 14

    hADME part

  2. 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)

    Time frame: Up to Day 14

    hADME part

  3. Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)

    Time frame: Up to Day 14

    hADME part

  4. 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-∞)

    Time frame: Up to day 13

    BA part

  5. 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-∞)

    Time frame: Up to Day 6

    BA part

Secondary outcomes

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

    Time frame: Up to Day 13

    hADME and BA part

  2. 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)

    Time frame: Up to Day 13

    hADME and BA part

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

    Time frame: Up to Day 13

    hADME part

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

    Time frame: Up to Day 13

    hADME part

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

    Time frame: Up to Day 6

    BA part

  6. AUC0-tz of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)

    Time frame: Up to Day 6

    BA part

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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