[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100269920":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":54,"centralContacts":33,"locations":58,"responsibleParty":71,"collaborators":33,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":33,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":33,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":97,"whyStopped":33,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Ascending Dose Crossover","EXPERIMENTAL","Single Ascending Dose in 4-way cross-over design (PF-06751979\u002FPlacebo).",[13,14],"Drug: PF-06751979 single dose","Drug: Placebo single dose",{"label":16,"type":10,"description":17,"interventionNames":18},"Multiple Ascending Dose","Multiple dose administration to Healthy Subjects in parallel cohorts (PF-06751979).",[19,20],"Drug: PF-06751979 multiple ascending dose","Drug: Placebo multiple ascending dose",{"label":22,"type":10,"description":23,"interventionNames":24},"Multiple Dose Elderly","Multiple dose administration to Healthy Elderly Subjects (PF-06751979). This cohort is optional.",[25,26],"Drug: PF-06751979 multiple dose","Drug: Placebo multiple elderly dose",[28,34,38,42,46,50],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","PF-06751979 single dose","PF-06751979 administered as a single dose suspension in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF 06751979). The planned dose levels are 200 mg, 400 mg, 700 mg, 200 mg fed (these doses are subject to change based on emerging data).",[9],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Placebo single dose","Matched Placebo suspension administered as single dose",[9],{"type":29,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"PF-06751979 multiple ascending dose","PF-06751979 suspension administered daily for 14 consecutive days to parallel cohorts. The planned dose levels are mg, 100 mg, 200 mg, 340 mg (these are subject to change based on emerging data).",[16],{"type":29,"name":43,"description":44,"armGroupLabels":45,"otherNames":33},"Placebo multiple ascending dose","Matched placebo suspension administered daily for 14 consecutive days.",[16],{"type":29,"name":47,"description":48,"armGroupLabels":49,"otherNames":33},"PF-06751979 multiple dose","PF-06751979 suspension administered daily for 14 consecutive days. The planned dose level is 340 mg (this is subject to change based on emerging data).",[22],{"type":29,"name":51,"description":52,"armGroupLabels":53,"otherNames":33},"Placebo multiple elderly dose","Multiple dose administration to Healthy Elderly Subjects (Placebo)",[22],[55],{"name":56,"affiliation":5,"role":57},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[59],{"facility":60,"status":33,"city":61,"state":33,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":33},"Pfizer Clinical Research Unit","Brussels","B-1070","Belgium","BE",{"type":66,"coordinates":67},"Point",[68,69],4.34878,50.85045,{"lat":69,"lon":68},{"type":72,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100269920","phase-1-clinical-trial-in-healthy-volunteers-and-health-elderly-volunteers-to-evaluate-the-safety-tolerability-and-blood-concentration-after-single-and-multiple-escalating-oral-doses-of-pf-06751979-100269920",true,"NCT02793232","Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.","A 3-part Phase 1, Randomized, Double-blind, Sponsor-open, Placebo Controlled Trial To Evaluate The Safety, Tolerability, Food Effect, Pharmacokinetics And Pharmacodynamics Of Pf-06751979 After Oral Administration: Part A - Single Ascending Doses In Healthy Adults; Part B - Multiple Ascending Doses In Healthy Adults; And Part C - Multiple Doses To Older Subjects","Inclusion Criteria:\n\n* Healthy female subjects of non childbearing potential and male subjects.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg\u002Fm2 (32 kg\u002Fm2 for healthy elderly); and a total body weight \\>50 kg (110 lbs) at Screening.\n* Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.\n* Additional criterion for subjects of Japanese descent who may be enrolled in Part B (multiple ascending dose cohorts in healthy subjects): Japanese subjects who have four Japanese grandparents 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* Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.\n* Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.\n* Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.\n* Any 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.","ALL","18 Years","85 Years",{"count":84,"type":85},46,"ACTUAL","INTERVENTIONAL",[88],"PHASE1","This study will test the safety, tolerability and blood concentrations of single and multiple oral doses of PF-06751979 in health subjects and healthy elderly subjects. PF-06751979 is being developed for the treatment of Alzheimer's disease.",[91],"Healthy Subjects",[93,94,95,96],"Safety","Tolerability","Pharmacokinetics","Alzheimer's disease","COMPLETED","2017-12-22",{"date":100,"type":85},"2018-09-17",{"date":102,"type":85},"2016-06-13",{"date":104,"type":85},"2017-01-05",{"name":5,"class":6},1]