NCT03842761

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

Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 685509 Over 28 Days in Patients With Mild and Moderate Hepatic Impairment and of Single Oral BI 685509 Dose Compared to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Healthy
• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	BI 685509	Tablet
DRUG	Placebo	Tablet

Timeline

• Start date: 2019-03-06
• Primary completion: 2021-04-09
• Completion: 2021-05-20
• First posted: 2019-02-15
• Last updated: 2021-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study