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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

NCT04722562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-01-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vericiguat (BAY1021189)

Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04722562 on ClinicalTrials.gov