A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems

Summary

The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment \[Child-Turcotte-Pugh (CTP) classification A and B\] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokinetics of different doses of BI 685509 in patients with mild to moderate hepatic impairment (CTP A and CTP B). In addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (CTP A and CTP B) of single BI 685509 dose to individually matched healthy volunteers

Timeline

Start

2019-03-06

Primary completion

2021-04-09

Completion

2021-05-20

Publications

• Lawitz EJ, Ertle J, Schoelch C, Gashaw I, McRae MP, Helmke SM, Everson GT. Hepatic improvement within 27 days of avenciguat treatment in Child-Pugh A cirrhosis detected by an oral cholate challenge test. Liver Transpl. 2024 Oct 1;30(10):982-990. doi: 10.1097/LVT.0000000000000420. Epub 2024 Jun 12.

Drugs

Indications