Safety and Tolerability of BI 685509 in Healthy Subjects

Phase 1 Completed 60 enrolled Boehringer Ingelheim

RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK), dose proportionality, the attainment of steady state, as well as investigation of linearity and pharmacodynamics (PD) of BI 685509 after multiple dosing.

Timeline

Start: 2017-04-24
Primary completion: 2018-06-01
Completion: 2018-06-01

Publications

Wong D, Seitz F, Bauer V, Giessmann T, Schulze F. Safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509, a soluble guanylyl cyclase activator, in healthy volunteers: Results from two randomized controlled trials. Naunyn Schmiedebergs Arch Pharmacol. 2024 Oct;397(10):8101-8116. doi: 10.1007/s00210-024-03165-w. Epub 2024 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avenciguat	Small molecule	1 mg	Oral
Subject	Avenciguat	Small molecule	2.5 mg	Oral
Subject	Avenciguat	Small molecule	3 mg	Oral
Subject	Avenciguat	Small molecule	4 mg	Oral
Subject	Avenciguat	Small molecule	5 mg	Oral

Indications

No indication recorded.