Status:
COMPLETED
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
Lead Sponsor:
Bayer
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Heart Failure
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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 hea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04722562
Start Date
July 16 2014
End Date
April 30 2015
Last Update
January 25 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lübeck, Germany, 23538