check_circleStudy Completed

Heart failure

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years

Trial summary

Enrollment Goal
27
Trial Dates
July 2014 - April 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Lübeck, 23538, Germany

Primary Outcome

  • AUC of vericiguat
    Area under the concentration vs. time curve from zero to infinity after single dose administration
    date_rangeTime Frame:
    Up to 96 hours
  • AUCu of vericiguat
    AUC unbound
    date_rangeTime Frame:
    Up to 96 hours
  • Cmax of vericiguat
    Maximum observed drug concentration in measured matrix after single dose administration
    date_rangeTime Frame:
    Up to 96 hours
  • Cmax,u of vericiguat
    Cmax unbound
    date_rangeTime Frame:
    Up to 96 hours

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3