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A Study in Healthy Men to Test How BI 1584862 is Processed in the Body
Sponsor: Boehringer Ingelheim
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
[13C]-labeled BI 1584862
\[13C\]-labeled BI 1584862, Reference treatment
Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862
BI 1584862 (C-14), Test treatment
Locations (1)
ICON-Groningen-62040
Groningen, Netherlands