[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100277673":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":28,"locations":33,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":28,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":28,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":28,"overallStatus":81,"whyStopped":28,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 - Subjects with severe renal impairment","EXPERIMENTAL","Subjects with severe renal impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).",[13],"Drug: BAY1841788",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1 - Subjects with moderate hepatic impairment","Subjects with moderate hepatic impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 1 - Healthy subjects","Healthy subjects received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets).",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","BAY1841788","600 mg single dose, administered as 2 x 300 mg tablets on Day 00.",[19,15,9],null,[30],{"name":31,"affiliation":5,"role":32},"Bayer Study Director","STUDY_DIRECTOR",[34,46],{"facility":28,"status":28,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":28},"Kiel","Schleswig-Holstein","24105","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],10.13489,54.32133,{"lat":44,"lon":43},{"facility":28,"status":28,"city":47,"state":28,"zip":48,"country":38,"countryCode":39,"cosmosGeoPoint":49,"geoPoint":53,"contacts":28},"Lübeck","23538",{"type":41,"coordinates":50},[51,52],10.68729,53.86893,{"lat":52,"lon":51},{"type":55,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[57],{"name":58,"class":6},"Orion Corporation, Orion Pharma","100277673","phase-1-effect-of-hepatic-and-renal-impairment-on-the-pharmacokinetics-safety-and-tolerability-of-bay1841788-odm-201-100277673",false,"NCT02894385","Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)","A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of BAY 1841788 (ODM-201) in Male Subjects With Hepatic Impairment, Renal Impairment and Normal Hepatic and Renal Function","Inclusion Criteria:\n\n* All subjects\n\n  \\-- Male and white subjects between 45 and 79 years of age with a body mass index between 18 to 34 kg\u002Fm\\*2 (both inclusive).\n* Patients with moderate hepatic impairment (Part 1)\n\n  \\-- Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan and with moderate hepatic impairment (defined as Child Pugh class B).\n* Patients with severe renal impairment (Part 1)\n\n  \\-- Patients with severe renal impairment with an estimated glomerular filtration rate 15-29 mL\u002Fmin\u002F1.73 m\\*2, who are not on dialysis and are not expected to start dialysis in the next 3 months (Stage 4).\n* Healthy subjects\n\n  \\-- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring and with estimated glomerular filtration rate \\>90 mL\u002Fmin (according to Modified Diet of Renal Disease equation).\n* Patients with moderate renal impairment (Part 2)\n\n  \\-- Patients with moderate renal impairment with an estimated glomerular filtration rate 30-59 mL\u002Fmin\u002F1.73 m\\*2 (Stage 3).\n* Patients with mild renal impairment (Part 2)\n\n  \\-- Patients with mild renal impairment with an estimated glomerular filtration rate (eGFR) 60-79 mL\u002Fmin\u002F1.73 m\\*2 (Stage 2).\n* Patients with mild hepatic impairment (Part 2)\n\n  * Patients with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan.\n  * Patients with mild hepatic impairment (defined as Child Pugh class A).\n\nExclusion Criteria:\n\n* Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV.\n* Subjects with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration.\n* Strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.\n* Known BCRP (breast cancer resistant protein) and OATP (organic anion-transporting polypeptide) substrates not specifically mentioned in the protocol within 28 days or 5 drug half-lives (if drug half-life in patients is known), before start of study treatment.\n* Smoking more than 20 cigarettes daily.",true,"MALE","45 Years","79 Years",{"count":71,"type":72},29,"ACTUAL","INTERVENTIONAL",[75],"PHASE1","Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).",[78,79,80],"Pharmacokinetics","Hepatic Insufficiency","Renal Insufficiency","COMPLETED","2019-01-04",{"date":84,"type":72},"2019-01-07",{"date":86,"type":72},"2016-09-13",{"date":88,"type":72},"2017-12-15",{"name":5,"class":6},2]