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

Bayer0 sites27 target enrollmentJuly 16, 2014

ConditionsHeart Failure

InterventionsVericiguat (BAY1021189)

DrugsVericiguat (BAY1021189)

Overview

Phase: Phase 1
Intervention: Vericiguat (BAY1021189)
Conditions: Heart Failure
Sponsor: Bayer
Enrollment: 27
Primary Endpoint: AUC of vericiguat
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 16, 2014

End Date

April 30, 2015

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For all subjects:
•Aged between 18 and 79 years (inclusive) with body mass index 18 to 34 kg/m\^2 (both inclusive)
•Women without childbearing potential; women of childbearing potential only if the pregnancy test was negative and a combination of condoms with a safe and highly effective
•For subjects with hepatic impairment:
•Subjects with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan
•Subjects with hepatic impairment (Child Pugh A or B)
•Subjects with stable liver disease in the last 2 months
•For healthy subjects:
•Mean age and body weight in the control group and in the two groups with hepatic impairment (Child Pugh A and B) should not vary by more than ± 10 years and ± 10 kg
•Gender matched

Exclusion Criteria

•For all subjects:
•Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
•Medical history of Kock pouch (ileostomy after proctocolectomy)
•Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
•Known gastrointestinal (GI) disorders (eg stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (eg Crohn's disease, ulcerative colitis)
•Febrile illness within 1 week prior to admission to study center
•Relevant diseases within the last 4 weeks prior to admission to study center
•Known severe allergies, non-allergic drug reactions, or multiple drug allergies
•Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
•Subjects with diagnosed malignancy within the past 5 years