[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100223298":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":58,"centralContacts":39,"locations":62,"responsibleParty":76,"collaborators":39,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":39,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":39,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":106,"whyStopped":39,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14,17,21,24,27,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Ascending Dose-1","EXPERIMENTAL","Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design",[13],"Drug: PF-06669571",{"label":15,"type":10,"description":11,"interventionNames":16},"Single Ascending Dose-2",[13],{"label":18,"type":10,"description":19,"interventionNames":20},"Multiple Ascending Dose-1","Daily dose of PF-06669571 in healthy volunteers",[13],{"label":22,"type":10,"description":19,"interventionNames":23},"Multiple Ascending Dose-2",[13],{"label":25,"type":10,"description":19,"interventionNames":26},"Multiple Ascending Dose-3",[13],{"label":28,"type":10,"description":19,"interventionNames":29},"Multiple Ascending Dose-4",[13],{"label":31,"type":10,"description":19,"interventionNames":32},"Multiple Ascending Dose-5",[13],[34,40,43,46,49,52,55],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","PF-06669571","Single ascending doses of PF-06669571 as extemporaneously prepared solution\u002Fsuspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo",[9],null,{"type":35,"name":36,"description":41,"armGroupLabels":42,"otherNames":39},"Single ascending doses of PF-06669571 as extemporaneously prepared solution\u002Fsuspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo",[15],{"type":35,"name":36,"description":44,"armGroupLabels":45,"otherNames":39},"Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution\u002Fsuspension or powder in capsule formulation for 14 days",[18],{"type":35,"name":36,"description":47,"armGroupLabels":48,"otherNames":39},"Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution\u002Fsuspension or powder in capsule formulation for 14 days",[22],{"type":35,"name":36,"description":50,"armGroupLabels":51,"otherNames":39},"Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution\u002Fsuspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme",[25],{"type":35,"name":36,"description":53,"armGroupLabels":54,"otherNames":39},"Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution\u002Fsuspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme",[28],{"type":35,"name":36,"description":56,"armGroupLabels":57,"otherNames":39},"Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution\u002Fsuspension or powder in capsule for 14 days. This dose may be reached by a titration scheme",[31],[59],{"name":60,"affiliation":5,"role":61},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[63],{"facility":64,"status":39,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":39},"New Haven Clinical Research Unit","New Haven","Connecticut","06511","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-72.92816,41.30815,{"lat":74,"lon":73},{"type":77,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100223298","phase-1-a-study-to-understand-safety-and-plasma-concentrations-of-pf-06669571-during-and-following-the-oral-administration-of-single-and-multiple-doses-of-pf-06669571-in-healthy-volunteers-under-fasted-and-fed-conditions-100223298",false,"NCT02184429","A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions","A Phase 1, Double Blind, Sponsor Open, Placebo Controlled Combined Single And Multiple Ascending Dose Study To Investigate The Safety, Tolerability And Food Effect On Pharmacokinetics Of PF-06669571 Following Oral Doses In Healthy Subjects","Inclusion Criteria:\n\n* Healthy male 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\nFemale subjects of non-childbearing potential must meet at least one of the following criteria:\n\n1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;\n2. Have undergone a documented hysterectomy and\u002For bilateral oophorectomy;\n3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and\u002For ovarian failure) will be considered to be of childbearing potential.\n\n   * Body Mass Index (BMI) of 17.5 to 30.5 kg\u002Fm2; and a total body weight \\>50 kg (110 lbs).\n   * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n   * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\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* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).\n* Screening supine blood pressure \\>= 140 mm Hg (systolic) or \\>=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is \\>=140 mm Hg (systolic) or \\>=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.\n* For subjects who answer \"Yes\" to the Columbia Suicide Severity Rating Scale (C-SSRS) questions 4 or 5, a risk assessment should be done by a qualified mental health professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to assess whether it is safe for the subject to participate in the study. In addition, subjects deemed by the investigator to be at significant risk of suicidal or violent behavior should be excluded.",true,"ALL","18 Years","55 Years",{"count":90,"type":91},56,"ACTUAL","INTERVENTIONAL",[94],"PHASE1","This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of food on PF-06669571 plasma concentrations will be be evaluated after a single dose of PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days",[97],"Healthy",[99,100,101,102,103,104,105],"First in human","single ascending dose study","multiple ascending dose study","safety and tolerability","pharmacokinetics","food effect","Parkinson's Disease","COMPLETED","2018-09-04",{"date":109,"type":91},"2018-09-06",{"date":111,"type":39},"2014-07",{"date":113,"type":91},"2015-03",{"name":5,"class":6},1]