[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100205979":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":19,"locations":25,"responsibleParty":38,"collaborators":19,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":19,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":19,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ASP3652","EXPERIMENTAL","One single dose",[13],"Drug: ASP3652",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Oral",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Clincial Study Manager","Astellas Pharma Europe B.V.","STUDY_CHAIR",[26],{"facility":27,"status":19,"city":28,"state":19,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":19},"Parexel Early Phase Clinical Unit","Harrow","H1 3UJ","United Kingdom","UK",{"type":33,"coordinates":34},"Point",[35,36],-0.33208,51.57835,{"lat":36,"lon":35},{"type":39,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100205979","phase-1-a-study-to-assess-the-effect-of-race-on-how-a-single-dose-of-asp3652-is-taken-up-metabolized-and-distributed-through-the-bodies-of-young-healthy-male-and-female-subjects-and-its-safety-and-tolerability-100205979",false,"NCT01958047","A Study to Assess the Effect of Race on How a Single Dose of ASP3652 is Taken up, Metabolized and Distributed Through the Bodies of Young, Healthy Male and Female Subjects, and Its Safety and Tolerability","A Phase 1 Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Dose of ASP3652 in Caucasian, Japanese, Black\u002FAfrican and Chinese Healthy Male and Female Subjects","Inclusion Criteria:\n\n* The subject is a healthy male or female subject from Caucasian, Japanese, Black\u002FAfrican or Chinese origin. Both parents and all 4 grandparents should be of the same race.\n* Subjects of Japanese or Chinese origin should be born in their respective countries and should not have lived outside of their countries for more than 5 years and 10 years, respectively.\n* The subject has a Body Mass Index (BMI) in the range 18.5 - 30.0 kg\u002Fm2, inclusive (subject from Caucasian or Black\u002FAfrican origin) or in the range 17.5 - 29.0 kg\u002Fm2, inclusive (subject from Japanese or Chinese origin). The subject weighs at least 50 kg (subject from Caucasian or Black\u002FAfrican origin) or at least 45 kg (subject from Japanese or Chinese origin).\n\nExclusion Criteria:\n\n* Female subject who is pregnant, has been pregnant within 6 months before screening, or breast feeding within 3 months before screening.\n* Known or suspected hypersensitivity to ASP3652 or any components of the formulation used.\n* The subject has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the Clinical Unit.",true,"ALL","20 Years","55 Years",{"count":52,"type":53},64,"ACTUAL","INTERVENTIONAL",[56],"PHASE1","This study investigates how ASP3652 is taken up, broken down, and distributed through the body and excreted in individuals of different races. The study also investigates levels of biochemical markers in the bloodstream, and determines how safe the study drug is and how well it is tolerated after dosing. A further aim is to look at how the processes of metabolism, distribution and excretion of the study drug are possibly altered by the daily diet of the volunteers taking part.",[59,60,61,62],"Pharmacokinetics","Pharmacodynamics","Healthy Subjects","Effect of Race",[64,9,65,66],"Phase I","Single dose","Dietary intake","COMPLETED","2013-10-04",{"date":70,"type":71},"2013-10-08","ESTIMATED",{"date":73,"type":19},"2012-07",{"date":75,"type":53},"2012-09",{"name":23,"class":6},1]