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

NCT07693218 | Recruiting Phase 1

• 3 other identifiers: 1485-00122025-523949-10U1111-1328-2409
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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)

  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)

  Up to 24 days

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

  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)

  Up to 24 days

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

  Up to 24 days

Secondary Outcomes (6)

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

  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)

  Up to 24 days

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

  Up to 24 days

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

  Up to 24 days

• Cmax of [13C]- BI 1815368

  Up to 24 days

Study Arms (1)

BI 1815368 (C-14) (Test) followed by BI 1815368 (C-13) (Reference)

EXPERIMENTAL

Drug: BI 1815368 (C-14); Drug: BI 1815368 (C-13)

Interventions

BI 1815368 (C-14) DRUG

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

BI 1815368 (C-14) (Test) followed by BI 1815368 (C-13) (Reference)

BI 1815368 (C-13) DRUG

\[13C\]-labeled BI 1815368

BI 1815368 (C-14) (Test) followed by BI 1815368 (C-13) (Reference)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

ICON-Groningen-62040

Groningen, 9728 NZ, Netherlands

RECRUITING

Related Links

• Related Info

MeSH Terms

Interventions

Carbon-14

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

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

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)