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A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Liver Disease and in Age-, Weight- and Gender-matched Healthy Participants

Heart Failure Clinical Trial

Official title:
Investigation of the Pharmacokinetics, Safety, and Tolerability of Vericiguat (BAY1021189) in Subjects With Hepatic Impairment (Classified as Child Pugh A or B) and in Age-, Weight-, and Gender-matched Healthy Subjects Following a Single Oral Dose in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification

Clinical Trial Summary

Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which the heart has trouble pumping blood through the body. Liver impairment which co-occurs in patients with heart failure is a common condition in which the liver is not removing the drugs from the blood as well as it should. The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it was tolerated and the way the body absorbed, distributed and excreted the study dug given as a single oral dose of 2.5 mg tablet in participants with liver impairment and healthy participants matched for age-, gender-, and weight. The participants stayed at the trial site for about 5 days. During this time, the doctors took blood and urine samples and checked the participants' health. About 7 after the participants took vericiguat (BAY1021189), the researchers checked the participants' health again and asked about any medical problems they had.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04722562
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 1
Start date July 16, 2014
Completion date April 30, 2015
View Details
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