[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100214304":3},{"organization":4,"armGroups":7,"interventions":47,"overallOfficials":85,"centralContacts":53,"locations":89,"responsibleParty":103,"collaborators":53,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":53,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":53,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":133,"whyStopped":53,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14,18,21,25,29,33,37,42],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Dosing in healthy Western subjects.",[13],"Drug: 0.15 mg PF-06649751",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2",[17],"Drug: 0.5 mg PF-06649751",{"label":19,"type":10,"description":11,"interventionNames":20},"Cohort 3",[17],{"label":22,"type":10,"description":11,"interventionNames":23},"Cohort 4",[24],"Drug: 1.5 mg PF-06649751",{"label":26,"type":10,"description":11,"interventionNames":27},"Cohort 5",[28],"Drug: 1.5 mg PF-06649751 21 Days",{"label":30,"type":10,"description":11,"interventionNames":31},"Cohort 6",[32],"Drug: 3.0 mg PF-06649751",{"label":34,"type":10,"description":11,"interventionNames":35},"Cohort 7",[36],"Drug: 5.0 mg PF-06649751",{"label":38,"type":10,"description":39,"interventionNames":40},"Optional Cohort 8","Dosing in healthy Western subjects. Cohort may not be conducted.",[41],"Drug: 8.0 mg PF-06649751",{"label":43,"type":10,"description":44,"interventionNames":45},"Cohort 9","Dosing in healthy Japanese subjects.",[46],"Drug: 1.5 mg PF-06649751 in healthy Japanese subjects",[48,54,58,61,65,69,73,77,81],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DRUG","0.15 mg PF-06649751","Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.",[9],null,{"type":49,"name":55,"description":56,"armGroupLabels":57,"otherNames":53},"0.5 mg PF-06649751","Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.",[15],{"type":49,"name":55,"description":59,"armGroupLabels":60,"otherNames":53},"Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.",[19],{"type":49,"name":62,"description":63,"armGroupLabels":64,"otherNames":53},"1.5 mg PF-06649751","Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.",[22],{"type":49,"name":66,"description":67,"armGroupLabels":68,"otherNames":53},"1.5 mg PF-06649751 21 Days","Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.",[26],{"type":49,"name":70,"description":71,"armGroupLabels":72,"otherNames":53},"3.0 mg PF-06649751","Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.",[30],{"type":49,"name":74,"description":75,"armGroupLabels":76,"otherNames":53},"5.0 mg PF-06649751","Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.",[34],{"type":49,"name":78,"description":79,"armGroupLabels":80,"otherNames":53},"8.0 mg PF-06649751","Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.",[38],{"type":49,"name":82,"description":83,"armGroupLabels":84,"otherNames":53},"1.5 mg PF-06649751 in healthy Japanese subjects","Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.",[43],[86],{"name":87,"affiliation":5,"role":88},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[90],{"facility":91,"status":53,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":53},"New Haven Clinical Research Unit","New Haven","Connecticut","06511","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-72.92816,41.30815,{"lat":101,"lon":100},{"type":104,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100214304","phase-1-a-study-to-observe-safety-and-blood-concentrations-of-pf-06649751-during-and-following-the-oral-administration-of-multiple-doses-of-pf-06649751-in-healthy-adult-western-and-japanese-volunteers-100214304",false,"NCT02066909","A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers","A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of Pf-06649751 In Healthy Western And Japanese Subjects","Inclusion Criteria:\n\n* Healthy males and\u002For female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).\n* Body Mass Index (BMI) of 17.5 to 30.5 kg\u002Fm2; and a total body weight \\>50 kg (110 lbs).\n* Cohort 9 only: Japanese subjects must have four biologic Japanese grandparents who were born in Japan.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.",true,"ALL","18 Years","55 Years",{"count":117,"type":118},77,"ACTUAL","INTERVENTIONAL",[121],"PHASE1","This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the safety\u002Ftolerability and PK data from the Western and Japanese populations.",[124],"Healthy",[126,127,128,129,130,131,132],"pharmacokinetics","safety","tolerability","healthy volunteers","steady state","multiple doses","Japanese subjects","COMPLETED","2015-06-23",{"date":136,"type":137},"2015-06-24","ESTIMATED",{"date":139,"type":53},"2014-02",{"date":141,"type":118},"2015-04",{"name":5,"class":6},1]