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

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 1815368 (C-14); Drug: BI 1815368 (C-13)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • ICON-Groningen-62040
    • Contact: Boehringer Ingelheim; Phone Number: 08000204613; Email: nederland@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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
2. Age of 18 to 55 years (inclusive) at screening
3. Body mass index (BMI) of 18.5 to 29.9 kg / m2 (inclusive) at screening
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-related procedure

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as assessed by the investigator
2. 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
3. Any laboratory value outside the reference range as judged by the investigator
4. Any evidence of a concomitant disease considered clinically relevant by the investigator Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 1815368 (C-14) (Test) followed by BI 1815368 (C-13) (Reference)	Drug: BI 1815368 (C-14); Unlabeled BI 1815368 mixed with [C-14]-labeled BI 1815368; Drug: BI 1815368 (C-13); [13C]-labeled BI 1815368

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
AUC0-tz of [13C]- BI 1815368	Up to 24 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 5, 2026

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Carbon-14
• Other Study ID Numbers: 1485-0012; 2025-523949-10 (Registry Identifier: CTIS (EU)); U1111-1328-2409 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No