[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100116905":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":35,"locations":36,"responsibleParty":79,"collaborators":35,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":35,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":35,"studyType":94,"phases":95,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":103,"whyStopped":104,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Repros Therapeutics Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"50 mg Proellex Mild impairment","ACTIVE_COMPARATOR","50 mg Proellex single dose Female subjects with mild renal impairment function.",[13],"Drug: 50 mg Proellex",{"label":15,"type":10,"description":16,"interventionNames":17},"50 mg Proellex Moderate","50 mg Proellex, Female subjects with moderate renal impairment function.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"50 mg Proellex, Normal","50 mg Proellex, Female subjects with normal renal function.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","50 mg Proellex","Single dose",[9,15,19],[29,30],"Telapristone acetate","Proellex",[32],{"name":33,"affiliation":5,"role":34},"Andre van As, MD, PhD","STUDY_DIRECTOR",null,[37,50,59,69],{"facility":38,"status":35,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":35},"Clinical Pharmacology of Miami, Inc","Miami","Florida","33014-3616","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-80.19366,25.77427,{"lat":48,"lon":47},{"facility":51,"status":35,"city":52,"state":40,"zip":53,"country":42,"countryCode":43,"cosmosGeoPoint":54,"geoPoint":58,"contacts":35},"Orlando Clinical Research Center","Orlando","32809",{"type":45,"coordinates":55},[56,57],-81.37924,28.53834,{"lat":57,"lon":56},{"facility":60,"status":35,"city":61,"state":62,"zip":63,"country":42,"countryCode":43,"cosmosGeoPoint":64,"geoPoint":68,"contacts":35},"DaVita Clinical Research","Minneapolis","Minnesota","55404",{"type":45,"coordinates":65},[66,67],-93.26384,44.97997,{"lat":67,"lon":66},{"facility":70,"status":35,"city":71,"state":72,"zip":73,"country":42,"countryCode":43,"cosmosGeoPoint":74,"geoPoint":78,"contacts":35},"New Orleans Center for Clinical Research - Knoxville","Knoxville","Tennessee","37920",{"type":45,"coordinates":75},[76,77],-83.92074,35.96064,{"lat":77,"lon":76},{"type":80,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100116905","phase-1-evaluate-pk-and-safety-of-proellex-in-females-with-various-stages-of-impaired-renal-function-and-healthy-females-100116905",true,"NCT00787618","Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females","A Single-Dose, Open-Label, Parallel Group Study To Evaluate The Pharmacokinetics And Safety Profile Of PROELLEX® (CDB-4124) In Female Subjects With Various Stages Of Impaired Renal Function And In Healthy Female Volunteers","Inclusion Criteria:\n\n* Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;\n* Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, is preferred\n* Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function\n* Subject with renal impairment must have evidence of stable disease\n* If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.\n* Negative urine pregnancy test at screening visit\n* Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control\n* Healthy subject must have no significant abnormal findings at the screening physical examination\n* Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)\n* Additional inclusion criteria may apply\n\nExclusion Criteria:\n\n* Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant\n* Subject with clinically significant abnormal liver function\n* Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study\n* An acute illness within five (5) days of study medication administration\n* Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system\n* Additional exclusion criteria may apply","FEMALE","18 Years","48 Years",{"count":92,"type":93},6,"ACTUAL","INTERVENTIONAL",[96,97],"PHASE1","PHASE2","PK and safety profile of Proellex® in females with various stages of impaired renal function",[100],"Renal Impairment",[102],"Renal impairment","TERMINATED","Increased LFTs","2014-08-08",{"date":107,"type":108},"2014-08-25","ESTIMATED",{"date":110,"type":35},"2008-10",{"date":112,"type":93},"2009-07",{"name":5,"class":6},4]