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First received: July 03, 2026

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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy

Study Type: INTERVENTIONAL


Official Title: 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

Brief Summary: The main objectives are:* To assess mass balance by determining the extent of recovery of total \[¹?C\]-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

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