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RECRUITING
NCT07693218
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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

DRUG

BI 1815368 (C-14)

Unlabeled BI 1815368 mixed with \[C-14\]-labeled BI 1815368

DRUG

BI 1815368 (C-13)

\[13C\]-labeled BI 1815368

Locations (1)

ICON-Groningen-62040

Groningen, Netherlands