Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07336758
PHASE1

A Study in Healthy Men to Test How BI 1584862 is Processed in the Body

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-01-22

Completion Date

2026-03-04

Last Updated

2026-06-23

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

ICON-Groningen-62040

Groningen, Netherlands