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

NCT07693218 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-08-18

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-16
Primary Completion
2026-09-05
Completion
2026-09-05

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07693218 on ClinicalTrials.gov