[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100227837":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":40,"centralContacts":11,"locations":45,"responsibleParty":58,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":88,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",[8,14,19,22,25,28],{"label":9,"type":10,"description":11,"interventionNames":12},"1: Placebo dose level","PLACEBO_COMPARATOR",null,[13],"Drug: Placebo",{"label":15,"type":16,"description":11,"interventionNames":17},"2: ASP3652 lowest dose level twice daily","EXPERIMENTAL",[18],"Drug: ASP3652",{"label":20,"type":16,"description":11,"interventionNames":21},"3:ASP3652 low dose level twice daily",[18],{"label":23,"type":16,"description":11,"interventionNames":24},"4: ASP3652 medium dose level twice daily",[18],{"label":26,"type":16,"description":11,"interventionNames":27},"5: ASP3652 high dose level twice daily",[18],{"label":29,"type":16,"description":11,"interventionNames":30},"6: ASP3652 highest dose level once daily",[18],[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"DRUG","ASP3652","oral",[15,20,23,26,29],{"type":33,"name":38,"description":35,"armGroupLabels":39,"otherNames":11},"Placebo",[9],[41],{"name":42,"affiliation":43,"role":44},"Central Contact","Astellas Pharma Europe B.V.","STUDY_CHAIR",[46],{"facility":47,"status":11,"city":48,"state":11,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":11},"PRA International","Groningen","9713GZ","Netherlands","NL",{"type":53,"coordinates":54},"Point",[55,56],6.56667,53.21917,{"lat":56,"lon":55},{"type":59,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100227837","phase-1-a-study-to-assess-the-safety-tolerability-and-effects-in-and-on-the-body-of-healthy-young-and-elderly-male-and-female-subjects-of-ascending-multiple-oral-doses-of-asp3652-100227837",false,"NCT02243657","A Study to Assess the Safety, Tolerability, and Effects in and on the Body of Healthy Young and Elderly Male and Female Subjects of Ascending Multiple Oral Doses of ASP3652","A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Multiple Oral Doses of ASP3652 in Healthy Young and Elderly Male and Female Subjects","Inclusion Criteria:\n\n* Body Mass Index (BMI) between 18.5-30.0 kg\u002Fm2 for both male and female subjects.\n* Male subject is non-fertile, i.e. surgically sterilized or practices an adequate contraceptive method to prevent pregnancies.\n* Female subject is of non-child bearing potential, i.e. post menopausal, surgically sterilized, hysterectomy in medical history, or practices adequate (double barrier) non-hormonal contraceptive method to prevent pregnancies.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding within 6 months before screening assessment.\n* Presence or history of any clinically significant psychiatric disorder such as mania, depression or schizophrenia.\n* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.",true,"ALL","18 Years",{"count":71,"type":72},101,"ACTUAL","INTERVENTIONAL",[75],"PHASE1","The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body. In addition, the effects of age and gender are investigated.\n\nThe study consists of two parts. In Part 1 four dose levels are administered to four separate groups initially. Two additional dosages are then investigated. Subjects receive either a once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.\n\nPart 2 is performed in one group of elderly healthy male or female (post-menopausal) subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.\n\nFor both parts of the study, the subjects stay in the clinic for one period of 18 days.",[78,79,80],"Healthy Subjects","Pharmacokinetics of ASP3652","Pharmacodynamics of ASP3652",[34,82,83,84,85,86,87],"Age","Gender","Pharmacokinetics","Pharmacodynamics","Phase 1","Multiple Ascending Doses (MAD)","COMPLETED","2014-09-16",{"date":91,"type":92},"2014-09-18","ESTIMATED",{"date":94,"type":11},"2009-05",{"date":96,"type":72},"2010-05",{"name":43,"class":6},1]