A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy, Hepatic Insufficiency
In brief
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
Key facts
- Study ID
- NCT03842761
- Run by
- Boehringer Ingelheim
- People needed
- 64
- Starts
- 2019-03-06
- Expected to finish
- 2021-05-20
- Last updated by the study team
- 2021-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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