Status:
COMPLETED
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
Lead Sponsor:
Bayer
Conditions:
Clinical Pharmacology
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease. The goal of the study is to learn ...
Eligibility Criteria
Inclusion
- Inclusion criteria for all subjects:
- Male and female white subjects with 18 to ≤79 years of age, BMI between 18 and 34 kg/m\^2
- Women without childbearing potential or with childbearing potential but only if the pregnancy test is negative and are under highly effective contraception
- Inclusion criteria for subjects with renal failure:
- \- Stable renal disease, ie. a serum creatinine value determined at least 3 - 6 months before the pre-study visit was not allowed to vary by more than 20% from the serum creatinine value determined at the pre-study visit
- Inclusion criteria for healthy subjects:
- \- Mean age and body weight not allowed to vary by more than +/- 10 years and +/- 10 kg from the subjects with renal impairment, respectively
- Exclusion criteria for all subjects:
- Febrile illness within 1 week before the start of the study
- Hypersensitivity to riociguat and / or to inactive constituents
- Smoking
- Exclusion criteria for subjects with renal failure:
- Resting heart rate in the awake subject below 45 BPM or above 90 BPM
- Acute renal failure or nephritis
- Any organ transplant
- Diastolic blood pressure (DBP) \>100 mmHg and / or systolic blood pressure (SBP) \>180 mmHg
- Hemoglobin \<8 g/dL, Proteinuria \>8 g/24 hours, Serum albumin \<30 g/L, Platelet count \<100 x 109/L
- History of bleeding within the past 3 months
- Diabetes mellitus with a fasting blood glucose \>220 mg/dL or HbA1c \>10%
- Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications
- Concomitant use of phosphodiesterase-5 inhibitors, endothelin receptor antagonists (ERAs, eg bosentan), intravenous or inhalative prostacyclins, or nitrates
- Concomitant use of potent CYP3A4 inhibitors
- Exclusion criteria for healthy subjects:
- Conspicuous findings in medical history or pre-study examination
- History of relevant diseases of vital organs, central nervous system, or other organs
- SBP below 100 mmHg or above 145 mmHg and / or DBP above 95 mmHg
- Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
Exclusion
Key Trial Info
Start Date :
February 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04364464
Start Date
February 19 2010
End Date
September 20 2011
Last Update
April 28 2020
Active Locations (1)
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1
Kiel, Schleswig-Holstein, Germany, 24105