A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Kidney 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 contraception method was granted

For subjects with renal impairment:

• With an estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m^2 determined from a serum creatinine control 2-14 days prior to dosing
• Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit

For healthy subjects:

• eGFR ≥ 90 mL/min/1.73m^2 determined from serum creatinine 2-14 days prior to dosing
• Healthy subjects with age-, weight- and gender- matched to renal impaired subjects

Exclusion Criteria:

For all subjects:

• Febrile illness within 1 week before the start of the study
• History of severe allergies, non-allergic drug reactions, or multiple drug allergies
• Hypersensitivity to the investigational drug, the control agent and/ or to inactive constituents
• Regular daily consumption of more than 1/2 liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form or more than 1 liter of xanthine-containing beverages or more than 10 cigarettes
• Positive testing in the drug screening
• Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
• Donation of more than 100 mL of blood in the preceding 4 weeks or 500 mL in the preceding 3 months
• Relevant deviation from the normal range in clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator For subjects with renal impairment
• Acute renal failure
• Acute nephritis
• Any organ transplant in the past 5 years
• 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
• Percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to dosing
• Diagnosed malignancy within the past 5 years
• Failure of any other major organ system other than the kidney
• Concomitant use of any medication except medications necessary for the treatment of diseases
• Diastolic BP >100 mmHg and/or systolic BP >180 mmHg
• Heart rate below 50 beats/min or above 100 beats/min at screening visit
• Significant uncorrected rhythm or conduction disturbances For healthy subjects
• Subjects with conspicuous findings in medical history or pre-study examination
• A history of relevant diseases of vital organs, of the central nervous system or other organs
• Excluded therapies (e.g. physiotherapy, acupuncture, etc.) from 1 week before admission to the ward (-01d)
• Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
• Systolic BP below 100 mmHg or above 145 mmHg and Diastolic BP below 55 mmHg or above 95 mmHg
• Heart rate below 50 beats/min or above 100 beats/min
• Clinically relevant findings in the electrocardiogram (ECG)