[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100390645":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":32,"locations":37,"responsibleParty":50,"collaborators":32,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":32,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":32,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":32,"overallStatus":72,"whyStopped":32,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Riociguat, Child Pugh A","EXPERIMENTAL","Participants with liver cirrhosis and mild hepatic impairment received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state",[13],"Drug: Riociguat (Adempas, BAY 63-2521)",{"label":15,"type":10,"description":16,"interventionNames":17},"Riociguat, Child Pugh B","Participants with liver cirrhosis and moderate hepatic impairment received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Riociguat, control A","Healthy age-, weight-, and gender- matched participants to Child Pugh A group received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Riociguat, control B","Healthy age-, weight-, and gender- matched participants to Child Pugh B group received a single dose of 1 mg (2 x 0.5 mg IR tablet) of riociguat in the fasted state",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Riociguat (Adempas, BAY 63-2521)","0.5 mg riociguat as an immediate-release (IR) tablet",[9,15,19,23],null,[34],{"name":35,"affiliation":5,"role":36},"Bayer Study Director","STUDY_DIRECTOR",[38],{"facility":32,"status":32,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":32},"Kiel","Schleswig-Holstein","24105","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],10.13489,54.32133,{"lat":48,"lon":47},{"type":51,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100390645","phase-1-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-100390645",false,"NCT04366622","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","Investigation of Pharmacokinetics, Safety, and Tolerability of BAY 63-2521 in Male and Female Subjects With Hepatic Impairment (Classified as Child Pugh A or B) and in Age-, Weight- and Gender-matched Healthy Subjects Following a Single Oral Dose of 1 mg BAY 63-2521 in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification","Inclusion criteria for all subjects:\n\n* Male and female White subjects 18 to ≤79 years of age, BMI between 18 and 34 kg\u002Fm\\^2\n* Women without childbearing potential or with childbearing potential but only if the pregnancy test is negative and are under highly effective contraception\n\nInclusion criteria for subjects with liver cirrhosis:\n\n* Documented liver cirrhosis confirmed by histopathology, eg previous liver biopsy, laparoscopy, or ultrasound Hepatic impairment (Child Pugh A or B)\n* Stable liver disease\n\nInclusion criteria for healthy subjects:\n\n\\- Age- (+\u002F-10 years), weight- (+\u002F-10 kg body weight), and gender-matched to a subject with liver cirrhosis as far as possible\n\nExclusion criteria for all subjects:\n\n* Febrile illness within 1 week before the start of the study\n* Hypersensitivity to riociguat and \u002F or to inactive constituents\n* Smoking\n\nExclusion criteria for subjects with liver cirrhosis:\n\n* Hemoglobin \\\u003C8 g\u002FdL\n* 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\n* Evidence of hepatic encephalopathy related to chronic liver disease \\> Grade II\n* Renal failure with a creatinine clearance \\\u003C40 mL\u002Fmin\n* Resting heart rate in the awake subject below 45 BPM or above 100 BPM\n* Systolic blood pressure (SBP) below 100 mmHg or above 160 mmHg, Diastolic blood pressure (DBP) above 95 mmHg\n* Platelet count \\\u003C30 x 10\\^9\u002FL\n* History of bleeding within the past 3 months\n* AP \\>4 times the upper limit of normal (ULN)\n* AST or ALT in conjunction with GGT \\>= 4 times the ULN (an isolated elevation of GGT \\>4 times ULN did not exclude the subject)\n* Serum albumin \\\u003C20 g\u002FL\n* Diabetes mellitus with a fasting blood glucose \\>220 mg\u002FdL or HbA1c \\>10%\n* Prothrombin time (Quick test) \\\u003C30%\n* Subjects who had undergone porto-caval shunt surgery\n* 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\n* Severe infection, malignancy, psychosis, or any clinically significant illness within 4 weeks prior to dosing\n* Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications\n* Concomitant use of phosphodiesterase-5 inhibitors, endothelin receptor antagonists (ERAs, eg bosentan), intravenous or inhalative prostacyclins, or nitrates\n* Concomitant use of potent CYP3A4 and P-gp inhibitors\n\nExclusion criteria for healthy subjects:\n\n* Conspicuous findings in medical history or pre-study examination\n* History of relevant diseases of vital organs, central nervous system, or other organs\n* Resting heart rate in the awake subject below 45 BPM or above 90 BPM\n* SBP below 100 mmHg or above 145 mmHg, DBP above 95 mmHg\n* Regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form",true,"ALL","18 Years","79 Years",{"count":64,"type":65},32,"ACTUAL","INTERVENTIONAL",[68],"PHASE1","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",[71],"Clinical Pharmacology","COMPLETED","2020-04-25",{"date":75,"type":65},"2020-04-29",{"date":77,"type":32},"2010-04-14",{"date":79,"type":65},"2011-09-15",{"name":5,"class":6},1]