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

Phase 1 Completed 12 enrolled Boehringer Ingelheim

Non-randomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2022-09-08
Primary completion: 2022-11-17
Completion: 2022-11-17

Publications

Joseph D, Wong D, Mitra P, Auclair AM, Wolfgang T, Gao E, Herich L, Tiessen R. Mass balance and absolute bioavailability of avenciguat (14C) after intravenous or oral administration in healthy male participants. Expert Opin Investig Drugs. 2026 Jan;35(1):75-84. doi: 10.1080/13543784.2025.2612329. Epub 2026 Jan 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avenciguat	Small molecule	30 ug	Intravenous
Subject	Avenciguat	Small molecule	3 mg	Intravenous

Indications

No indication recorded.