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 Kidney 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. Renal 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 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
- 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)
Key Trial Info
Start Date :
June 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04722484
Start Date
June 12 2014
End Date
January 22 2015
Last Update
January 25 2021
Active Locations (1)
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1
Kiel, Schleswig-Holstein, Germany, 24105