NCT06520553

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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)

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1569912 (C-14)	unlabelled BI 1569912 mixed with \[14C\]- labelled BI 1569912
DRUG	BI 1569912 (C-13)	\[13C\]- labelled BI 1569912

Timeline

• Start date: 2024-08-26
• Primary completion: 2024-10-03
• Completion: 2024-10-03
• First posted: 2024-07-25
• Last updated: 2024-11-14

Locations

1 site across 1 country: Netherlands