NCT05863130

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-05-03
• Primary completion: 2023-11-09
• Completion: 2023-11-09
• First posted: 2023-05-17
• Last updated: 2023-11-15

Locations

1 site across 1 country: Netherlands