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Completed

NCT Number: NCT07693218

A Study in Healthy Men to Test How BI 1815368 is Processed in the Body

The main objectives are:

* To assess mass balance by determining the extent of recovery of total [¹⁴C]-radioactivity in urine and faeces after a single oral dose administration of BI 1815368 (C-14) (test treatment T) in healthy male trial participants. * To investigate the absolute bioavailability of BI 1815368 using a single, concomitant intravenous micro-dose administration of BI 1815368 (C13) (reference treatment R). * To provide plasma, urine, and faecal samples

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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 as determined by 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
  • Body mass index (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 any trial-related procedure

Exclusion criteria

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as assessed 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 as judged by the investigator
  • Any evidence of a concomitant disease considered clinically relevant by the investigator Further exclusion criteria apply.

Treatment and study plan

BI 1815368 (C-14)

Drug

Unlabeled BI 1815368 mixed with [C-14]-labeled BI 1815368

BI 1815368 (C-13)

Drug

[13C]-labeled BI 1815368

Primary outcomes

  1. 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)

    Time frame: Up to 24 days

  2. Fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces,0-tz)

    Time frame: Up to 24 days

  3. Sum of fe urine,0-tz and fe faeces,0-tz (total recovery of [14C]-radioactivity)

    Time frame: Up to 24 days

  4. Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), after oral administration of BI 1815368 (C-14)

    Time frame: Up to 24 days

  5. AUC0-∞ of [13C]- BI 1815368, after a concomitant IV infusion of BI 1815368 (C-13)

    Time frame: Up to 24 days

Secondary outcomes

  1. Maximum measured concentration of BI 1815368 in plasma (Cmax), after oral administration of BI 1815368 (C-14)

    Time frame: Up to 24 days

  2. Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point, after oral administration of BI 1815368 (C-14)

    Time frame: Up to 24 days

  3. Cmax of [14C]-radioactivity, after oral administration of BI 1815368 (C-14)

    Time frame: Up to 24 days

  4. AUC0-tz of [14C]-radioactivity, after oral administration of BI 1815368 (C-14)

    Time frame: Up to 24 days

  5. Cmax of [13C]- BI 1815368

    Time frame: Up to 24 days

  6. AUC0-tz of [13C]- BI 1815368

    Time frame: Up to 24 days

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 1815368 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1815368 (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
Jul 9, 2026
Registry last updated
Sep 15, 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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