NCT07336758

A Study in Healthy Men to Test How BI 1584862 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 1584862 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1584862 (C-13) in Healthy Male Trial Participants (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). The study will measure how much of the study medicine is recovered in urine and faeces after taking it by mouth. It will also look at how much of the study medicine enters the bloodstream when taken by mouth compared to a small dose given directly into the bloodstream. The study staff measures the amount of BI 1584862 and its broken-down parts in the blood, the urine, and the stool.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[13C]-labeled BI 1584862	\[13C\]-labeled BI 1584862, Reference treatment
DRUG	Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862	BI 1584862 (C-14), Test treatment

Timeline

• Start date: 2026-01-22
• Primary completion: 2026-03-04
• Completion: 2026-03-04
• First posted: 2026-01-13
• Last updated: 2026-03-17

Locations

1 site across 1 country: Netherlands