NCT05515328

A Study in Healthy Men to Test How BI 685509 is Processed in the Body

Investigation of Metabolism and Pharmacokinetics and Absolute Bioavailability of BI 685509 (C-14) After Intravenous and Oral Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total radioactivity, including mass balance, excretion pathways and metabolism following administration of BI 685509 to healthy male subjects. The main objective of Part B is to determine the absolute bioavailability of BI 685509 after administration to healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[¹⁴C] BI 685509 formulation 1	\[¹⁴C\] BI 685509 formulation 1
DRUG	[¹⁴C] BI 685509 formulation 2	\[¹⁴C\] BI 685509 formulation 2
DRUG	BI 685509 formulation 3	BI 685509 formulation 3

Timeline

• Start date: 2022-09-08
• Primary completion: 2022-11-17
• Completion: 2022-11-17
• First posted: 2022-08-25
• Last updated: 2022-11-28

Locations

1 site across 1 country: Netherlands