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NCT06520553
PHASE1

A Study in Healthy Men to Test How BI 1569912 is Processed in the Body

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The main objectives of this trial are: * To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T). * To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)

Official title: A Double-micro-tracer Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Oral Dose of BI 1569912 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1569912 (C-13) in Healthy Male Subjects (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

2024-08-26

Completion Date

2024-10-03

Last Updated

2026-05-22

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

BI 1569912 (C-14)

10 milligram (mg) \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.

DRUG

BI 1569912 (C-13)

A single dose of 100 microgram (µg) \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.

Locations (1)

ICON-Groningen-62040

Groningen, Netherlands