[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100139854":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":42,"centralContacts":32,"locations":46,"responsibleParty":59,"collaborators":32,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":32,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":32,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":86,"whyStopped":32,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Single dose 3 period interleaved cross-over with placebo substitution",[13],"Drug: PF-04995274",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Single dose 4 period interleaved cross-over, placebo substitution, with food effect",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Single dose 4 period cross-over, placebo insertion, with food effect",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Optional Cohort 4","Single dose 3 period cross-over with placebo substitution",[13],[27,33,36,39],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","PF-04995274","Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.",[9],null,{"type":28,"name":29,"description":34,"armGroupLabels":35,"otherNames":32},"Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.",[15],{"type":28,"name":29,"description":37,"armGroupLabels":38,"otherNames":32},"Planned single PO 120mg and 210mg doses of PF-04995274",[19],{"type":28,"name":29,"description":40,"armGroupLabels":41,"otherNames":32},"single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data",[23],[43],{"name":44,"affiliation":5,"role":45},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[47],{"facility":48,"status":32,"city":49,"state":32,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":32},"Pfizer Investigational Site","Brussels","1070","Belgium","BE",{"type":54,"coordinates":55},"Point",[56,57],4.34878,50.85045,{"lat":57,"lon":56},{"type":32,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":60,"oldOrganization":61},"Director, Clinical Trial Disclosure Group","Pfizer, Inc.","100139854","phase-1-a-study-to-evaluate-the-safety-tolerability-and-plasma-drug-levels-following-a-single-dose-of-pf-04995274-in-healthy-adult-volunteers-100139854",false,"NCT01091272","A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Following A Single Dose Of PF-04995274 In Healthy Adult Volunteers","A Phase 1, First-Into-Human, Escalating Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04995274 After Administration Of Single Oral Doses To Healthy Adult Subjects","Inclusion Criteria:\n\n* For all cohorts, healthy male and\u002For female subjects of nonchildbearing 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 heart rate measurement, 12 lead ECG and clinical laboratory tests).\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 time of dosing).\n* Pregnant or nursing women; women of childbearing potential. Female subjects must be of non childbearing potential defined by a history of surgical sterilization (eg, hysterectomy or bilateral oophorectomy) or post menopausal status (complete absence of menses for at least two consecutive years) and elevated FSH concentration in women between 45 and 55.",true,"ALL","18 Years","55 Years",{"count":74,"type":75},28,"ACTUAL","INTERVENTIONAL",[78],"PHASE1","The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after administration of a single dose to healthy volunteers, and to evaluate the plasma drug concentrations after single dose in healthy volunteers.",[81],"Healthy",[83,84,85],"healthy volunteer","safety","pharmacokinetic","COMPLETED","2010-09-17",{"date":89,"type":90},"2010-09-20","ESTIMATED",{"date":92,"type":32},"2010-04",{"date":94,"type":75},"2010-09",{"name":5,"class":6},1]