[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100145703":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":25,"locations":36,"responsibleParty":49,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FosD","EXPERIMENTAL","Four sequential cohorts of Japanese subjects are planned with doses ranging from 50mg once daily to a maximum of 200mg twice daily. One cohort of White subjects is also planned to receive the same dose regimen as the third dose level in Japanese subjects",[13],"Drug: FosD",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo given (2 subjects in each cohort)",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","oral tablet",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29,32],{"name":30,"affiliation":5,"role":31},"Mark Layton, MD","STUDY_DIRECTOR",{"name":33,"affiliation":34,"role":35},"Mark Yen, MD","PAREXEL Early Phase\u002FCalifornia Clinical Trials Medical Group","PRINCIPAL_INVESTIGATOR",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"Research Site","Glendale","California","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.25508,34.14251,{"lat":47,"lon":46},{"type":50,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100145703","phase-1-a-study-to-assess-the-safety-tolerability-and-blood-and-urine-drug-levels-of-fostamatinib-disodium-fosd-in-healthy-japanese-and-white-subjects-100145703",false,"NCT01167868","A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects","A Phase I, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Fostamatinib Disodium in Healthy Japanese and White Subjects After Single and Multiple Ascending Doses","Inclusion Criteria:\n\n* Healthy male and female (of non-childbearing potential) Japanese subjects and White subjects (origins in Europe, the Middle East, or North Africa)\n* Body mass index (BMI) between 17 and 27 kg\u002Fm2 and weigh at least 45 kg and no more than 100 kg\n\nExclusion Criteria:\n\n* History or presence of respiratory, GI, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders\n* Any clinically significant illness, acute infection, known inflammatory process, medical\u002Fsurgical procedure or trauma within 4 weeks of the first administration of investigational product\n* Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1\n* Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product",true,"ALL","20 Years","45 Years",{"count":63,"type":64},56,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","This is a single and multiple ascending dose study in healthy male and female (of non-child bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid arthritis.",[70],"Healthy",[72,9,73,74,75,76,77,78],"fostamatinib disodium","Japanese","Healthy volunteers","Phase 1","Single and Multiple Ascending Dose Study","Healthy Japanese volunteers","Healthy White volunteers","COMPLETED","2013-02-06",{"date":82,"type":83},"2013-02-07","ESTIMATED",{"date":85,"type":25},"2010-07",{"date":87,"type":64},"2011-05",{"name":5,"class":6},1]