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COMPLETED
NCT05863130
PHASE1

A Study in Healthy Men to Test How BI 764198 is Processed in the Body

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism following oral administration to healthy male volunteers of a single oral dose of BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.

Official title: A Phase I, Open-label, Two-arm, Non-randomised Trial to Investigate the Metabolism and Pharmacokinetics of a Single Dose of BI 764198 (C-14) Administered as Oral Solution Using Two Different Approaches in Healthy Male Volunteers

Key Details

Gender

MALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-05-03

Completion Date

2023-11-09

Last Updated

2026-06-29

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

BI 764198 (C-14) (approach 1)

BI 764198 (C-14) (approach 1)

DRUG

BI 764198 (C-14) (approach 2)

BI 764198 (C-14) (approach 2)

Locations (1)

ICON

Groningen, Netherlands