[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100303814":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":29,"locations":34,"responsibleParty":48,"collaborators":29,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":29,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":29,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":29,"overallStatus":70,"whyStopped":29,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects with mild renal impairment","EXPERIMENTAL","Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets)",[13],"Drug: BAY1101042",{"label":15,"type":10,"description":11,"interventionNames":16},"Subjects with moderate renal impairment",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Subjects with severe renal impairment",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Matched healthy subject group",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","BAY1101042","Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)",[21,9,15,18],null,[31],{"name":32,"affiliation":5,"role":33},"Bayer Study Director","STUDY_DIRECTOR",[35],{"facility":36,"status":29,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":29},"CRS Clinical-Research-Services Kiel GmbH","Kiel","Schleswig-Holstein","24105","Germany","DE",{"type":43,"coordinates":44},"Point",[45,46],10.13489,54.32133,{"lat":46,"lon":45},{"type":49,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100303814","phase-1-clinical-study-to-evaluate-the-pharmacokinetics-safety-tolerability-and-pharmacodynamic-effects-of-a-single-oral-10-mg-bay1101042-tablet-dose-in-men-and-woman-with-renal-impairment-and-in-healthy-subjects-100303814",false,"NCT03235076","Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects","Investigation of Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 MR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight- Matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design","Inclusion Criteria:\n\n* Ability to understand and follow study-related instructions and ability to participate in the study for the entire period.\n* Age: 18 to 79 years (inclusive) at the screening visit.\n* Body mass index (BMI): 18 to 34 kg\u002Fm² (both inclusive).\n* Male or female subject.\n* Only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy).\n\nSubjects with renal impairment:\n\n* eGFR \\\u003C90 mL\u002Fmin\u002F1.73 m\\*2 determined from serum creatinine 2-10 days prior to dosing.\n* Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.\n\nHealthy subjects:\n\n\\- eGFR ≥90 mL\u002Fmin\u002F1.73 m\\*2 determined from serum creatinine 2-10 days prior to dosing.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator.",true,"ALL","18 Years","79 Years",{"count":62,"type":63},36,"ACTUAL","INTERVENTIONAL",[66],"PHASE1","To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.",[69],"Renal Impairment","COMPLETED","2023-06-02",{"date":73,"type":63},"2023-06-05",{"date":75,"type":63},"2017-08-15",{"date":77,"type":63},"2019-03-13",{"name":5,"class":6},1]