drugset / Trial / NCT04722562

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

NCT04722562

Phase 1 Completed 27 enrolled Bayer Merck Sharp & Dohme LLC · collab
Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2014-07-16
Primary completion
2015-01-21
Completion
2015-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Vericiguat Other / unclassified 2.5 mg Oral

Indications