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 | Completed Phase 1

• 2 other identifiers: 158402014-001206-18
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• AUC of vericiguat

  Area under the concentration vs. time curve from zero to infinity after single dose administration

  Up to 96 hours

• AUCu of vericiguat

  AUC unbound

  Up to 96 hours

• Cmax of vericiguat

  Maximum observed drug concentration in measured matrix after single dose administration

  Up to 96 hours

• Cmax,u of vericiguat

  Cmax unbound

  Up to 96 hours

Study Arms (3)

Child Pugh A

EXPERIMENTAL

Participants with mild hepatic impairment

Drug: Vericiguat (BAY1021189)

Child Pugh B

EXPERIMENTAL

Participants with moderate hepatic impairment

Drug: Vericiguat (BAY1021189)

Healthy participants

EXPERIMENTAL

Participants with normal hepatic function

Drug: Vericiguat (BAY1021189)

Interventions

Vericiguat (BAY1021189) DRUG

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

Child Pugh A; Child Pugh B; Healthy participants

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• For subjects with hepatic impairment:
• Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association grade III or IV, severe arrhythmia requiring anti-arrhythmic treatment
• Subjects with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration
• History of bleeding within the past 3 months
• Thrombotic disorder

Sponsors & Collaborators

• Bayer: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Unknown Facility

Lübeck, 23538, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Heart Failure

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: July 16, 2014
• Primary Completion: January 21, 2015
• Study Completion: April 30, 2015
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

DE (1)