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 Impaired Liver Function 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 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 liver cirrhosis:
- Documented liver cirrhosis confirmed by histopathology, eg previous liver biopsy, laparoscopy, or ultrasound Hepatic impairment (Child Pugh A or B)
- Stable liver disease
- Inclusion criteria for healthy subjects:
- \- Age- (+/-10 years), weight- (+/-10 kg body weight), and gender-matched to a subject with liver cirrhosis as far as possible
- 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 liver cirrhosis:
- Hemoglobin \<8 g/dL
- Severe cerebrovascular or cardiac disorders, eg myocardial infarction less than 6 months prior to dosing, congestive heart failure of NYHA grade III or IV, severe arrhythmia requiring antiarrhythmic treatment
- Evidence of hepatic encephalopathy related to chronic liver disease \> Grade II
- Renal failure with a creatinine clearance \<40 mL/min
- Resting heart rate in the awake subject below 45 BPM or above 100 BPM
- Systolic blood pressure (SBP) below 100 mmHg or above 160 mmHg, Diastolic blood pressure (DBP) above 95 mmHg
- Platelet count \<30 x 10\^9/L
- History of bleeding within the past 3 months
- AP \>4 times the upper limit of normal (ULN)
- AST or ALT in conjunction with GGT \>= 4 times the ULN (an isolated elevation of GGT \>4 times ULN did not exclude the subject)
- Serum albumin \<20 g/L
- Diabetes mellitus with a fasting blood glucose \>220 mg/dL or HbA1c \>10%
- Prothrombin time (Quick test) \<30%
- Subjects who had undergone porto-caval shunt surgery
- Use of medications known to interfere with hepatic metabolism (eg cimetidine, barbiturates, phenothiazines, etc) or known to alter other major organs or systems within 30 days prior to dosing
- Severe infection, malignancy, psychosis, or any clinically significant illness within 4 weeks prior to dosing
- 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 and P-gp 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
- Resting heart rate in the awake subject below 45 BPM or above 90 BPM
- SBP below 100 mmHg or above 145 mmHg, 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 :
April 14 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04366622
Start Date
April 14 2010
End Date
September 15 2011
Last Update
April 29 2020
Active Locations (1)
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1
Kiel, Schleswig-Holstein, Germany, 24105