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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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Vericiguat (BAY1021189)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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
  • Evidence of hepatic encephalopathy related to chronic liver disease > grade 2 (exclusion by Number Connection Test (NCT))
  • 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
  • Subjects with diabetes mellitus with a glycohemoglobin A1c (HbA1c) >10%
  • Severe ascites of more than 6 L (estimated by ultrasound)
  • Subjects with primary and secondary biliary cirrhosis
  • Subjects with sclerosing cholangitis
  • Failure of any other major organ system other than the liver
  • Severe infection, malignancy, or psychosis, or any clinically significant illness within 4 weeks prior to study drug administration

For healthy subjects:

  • 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
  • Subjects with conspicuous findings in medical history or pre-study examination
  • A history of relevant diseases of vital organs, the central nervous system, or other organs

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Child Pugh A

Child Pugh B

Healthy participants

Arm Description

Participants with mild hepatic impairment

Participants with moderate hepatic impairment

Participants with normal hepatic function

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 21, 2021
Last Updated
January 21, 2021
Sponsor
Bayer
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04722562
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2014 (Actual)
Primary Completion Date
January 21, 2015 (Actual)
Study Completion Date
April 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child Pugh A
Arm Type
Experimental
Arm Description
Participants with mild hepatic impairment
Arm Title
Child Pugh B
Arm Type
Experimental
Arm Description
Participants with moderate hepatic impairment
Arm Title
Healthy participants
Arm Type
Experimental
Arm Description
Participants with normal hepatic function
Intervention Type
Drug
Intervention Name(s)
Vericiguat (BAY1021189)
Intervention Description
Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)
Primary Outcome Measure Information:
Title
AUC of vericiguat
Description
Area under the concentration vs. time curve from zero to infinity after single dose administration
Time Frame
Up to 96 hours
Title
AUCu of vericiguat
Description
AUC unbound
Time Frame
Up to 96 hours
Title
Cmax of vericiguat
Description
Maximum observed drug concentration in measured matrix after single dose administration
Time Frame
Up to 96 hours
Title
Cmax,u of vericiguat
Description
Cmax unbound
Time Frame
Up to 96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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 Evidence of hepatic encephalopathy related to chronic liver disease > grade 2 (exclusion by Number Connection Test (NCT)) 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 Subjects with diabetes mellitus with a glycohemoglobin A1c (HbA1c) >10% Severe ascites of more than 6 L (estimated by ultrasound) Subjects with primary and secondary biliary cirrhosis Subjects with sclerosing cholangitis Failure of any other major organ system other than the liver Severe infection, malignancy, or psychosis, or any clinically significant illness within 4 weeks prior to study drug administration For healthy subjects: 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 Subjects with conspicuous findings in medical history or pre-study examination A history of relevant diseases of vital organs, the central nervous system, or other organs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Lübeck
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products

Learn more about this trial

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

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