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Recruiting NCT07693218

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BI 1815368 (C-14), BI 1815368 (C-13).
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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)

Overview

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

Interventions

  • Drug BI 1815368 (C-14)
    Unlabeled BI 1815368 mixed with \[C-14\]-labeled BI 1815368
  • Drug BI 1815368 (C-13)
    \[13C\]-labeled BI 1815368

Primary outcome measures

  • 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]
  • 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]
  • Sum of fe urine,0-tz and fe faeces,0-tz (total recovery of [14C]-radioactivity) [Time frame: Up to 24 days]
  • 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]
  • AUC0-∞ of [13C]- BI 1815368, after a concomitant IV infusion of BI 1815368 (C-13) [Time frame: Up to 24 days]
Secondary outcome measures (6)
  • Maximum measured concentration of BI 1815368 in plasma (Cmax), after oral administration of BI 1815368 (C-14) [Time frame: Up to 24 days]
  • 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]
  • Cmax of [14C]-radioactivity, after oral administration of BI 1815368 (C-14) [Time frame: Up to 24 days]
  • AUC0-tz of [14C]-radioactivity, after oral administration of BI 1815368 (C-14) [Time frame: Up to 24 days]
  • Cmax of [13C]- BI 1815368 [Time frame: Up to 24 days]
  • AUC0-tz of [13C]- BI 1815368 [Time frame: Up to 24 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • ICON-Groningen-62040 — Groningen

Identifiers

NCT: NCT07693218 · 1485-0012 · 2025-523949-10 · U1111-1328-2409

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗