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A Study in Healthy Men to Test How BI 1815368 is Processed in the Body
Sponsor: Boehringer Ingelheim
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
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-dose of BI 1815368 (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
10
Start Date
2026-07-16
Completion Date
2026-09-05
Last Updated
2026-07-23
Healthy Volunteers
Yes
Conditions
Interventions
BI 1815368 (C-14)
Unlabeled BI 1815368 mixed with \[C-14\]-labeled BI 1815368
BI 1815368 (C-13)
\[13C\]-labeled BI 1815368
Locations (1)
ICON-Groningen-62040
Groningen, Netherlands