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

This is an interventional other trial for Heart Failure Read More

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