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

Conditions: Clinical Pharmacology

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 more about the safety of bay 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 1 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight


Eligibility criteria:
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