TerminatedPhase 1

A Study to Test How BI 1819479 is Taken up and Processed by the Body

Stopped: Company decision

United Kingdom7 participantsStarted 2025-08-04

Plain-language summary

This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers.

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male participants 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 without any clinically significant abnormalities
. Age of 18 to 55 years (inclusive)
. Body Mass Index (BMI) of 18.5 to 32.0 kg/m\^2 (inclusive)
. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
. Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day), applicable to Part A only

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine, 0-tz)

Timeframe: Up to 37 days.

Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces, 0-tz)

Timeframe: Up to 37 days.

Part B: area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

Timeframe: Up to 31 days.

Trial details

NCT IDNCT07065617

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-04

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male participants 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 without any clinically significant abnormalities
. Age of 18 to 55 years (inclusive)
. Body Mass Index (BMI) of 18.5 to 32.0 kg/m\^2 (inclusive)
. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
. Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day), applicable to Part A only

Exclusion criteria

What they're measuring

Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine, 0-tz)

Timeframe: Up to 37 days.

Part A: fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces, 0-tz)

Timeframe: Up to 37 days.

Part B: area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

Timeframe: Up to 31 days.