[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100186790":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":76,"centralContacts":11,"locations":80,"responsibleParty":93,"collaborators":11,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":11,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":11,"overallStatus":116,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,15,18,21,24,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A Cohort 1","EXPERIMENTAL",null,[13,14],"Drug: PF-06282999","Drug: Placebo",{"label":16,"type":10,"description":11,"interventionNames":17},"Part A Cohort 2",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"Part A Cohort 3",[13,14],{"label":22,"type":10,"description":11,"interventionNames":23},"Part A Cohort 4",[13,14],{"label":25,"type":10,"description":11,"interventionNames":26},"Part A Cohort 5",[13,14],{"label":28,"type":10,"description":11,"interventionNames":29},"Part B Cohort 1",[30,13],"Drug: midazolam",{"label":32,"type":10,"description":11,"interventionNames":33},"Part B Cohort 2",[30,13],[35,40,44,47,49,52,54,57,59,62,65,69,72,74],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"DRUG","PF-06282999","Tablet, 10 mg, every 8 hours, 14 days",[9],{"type":36,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"Placebo","Tablet, 0 mg, every 8 hours, 14 days",[9],{"type":36,"name":37,"description":45,"armGroupLabels":46,"otherNames":11},"Tablet, 30 mg, every 8 hours, 14 days",[16],{"type":36,"name":41,"description":42,"armGroupLabels":48,"otherNames":11},[16],{"type":36,"name":37,"description":50,"armGroupLabels":51,"otherNames":11},"Tablet, 100 mg, every 8 hours, 14 days",[19],{"type":36,"name":41,"description":42,"armGroupLabels":53,"otherNames":11},[19],{"type":36,"name":37,"description":55,"armGroupLabels":56,"otherNames":11},"Tablet, 250 mg, every 8 hours, 14 days",[22],{"type":36,"name":41,"description":42,"armGroupLabels":58,"otherNames":11},[22],{"type":36,"name":37,"description":60,"armGroupLabels":61,"otherNames":11},"Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days",[25],{"type":36,"name":41,"description":63,"armGroupLabels":64,"otherNames":11},"Tablet, 0 mg, every 8 or 12 hours, 14 days",[25],{"type":36,"name":66,"description":67,"armGroupLabels":68,"otherNames":11},"midazolam","Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14",[28],{"type":36,"name":37,"description":70,"armGroupLabels":71,"otherNames":11},"Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days",[28],{"type":36,"name":66,"description":67,"armGroupLabels":73,"otherNames":11},[32],{"type":36,"name":37,"description":70,"armGroupLabels":75,"otherNames":11},[32],[77],{"name":78,"affiliation":5,"role":79},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[81],{"facility":82,"status":11,"city":83,"state":11,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":11},"Pfizer Investigational Site","Brussels","B-1070","Belgium","BE",{"type":88,"coordinates":89},"Point",[90,91],4.34878,50.85045,{"lat":91,"lon":90},{"type":94,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100186790","phase-1-a-study-to-test-the-safety-amount-and-effects-of-pf-06282999-in-healthy-overweight-adults-and-a-study-to-test-the-effects-of-pf-06282999-on-the-amount-of-the-approved-drug-midazolam-in-healthy-adults-100186790",false,"NCT01707082","A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults","A Phase 1, Randomized, Placebo-Controlled, Multiple Dose Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of PF-06282999 In Healthy Overweight Subjects And A Fixed-Sequence Study To Assess The Effect Of PF-06282999 On The Pharmacokinetics Of Midazolam In Healthy Subjects","B521MAD","Inclusion Criteria:\n\n* Healthy male and\u002For female subjects 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). Women must be of non childbearing potential.\n* Body Mass Index (BMI) of 27.0 to 35.0 kg\u002Fm2 (Part A) or 17.5 to 30.5 kg\u002Fm2 (Part B); and a total body weight \\>50 kg (110 lbs).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* Subject with any contraindication to midazolam according to the country specific labeling or subject with previous intolerance or allergy to benzodiazepines (applicable to Part B of study only).\n* Subjects who were enrolled in Part A are excluded from participation in Part B of this study.\n* Subjects who have previously participated in a study with PF-06282999.",true,"ALL","18 Years","55 Years",{"count":108,"type":109},69,"ACTUAL","INTERVENTIONAL",[112],"PHASE1","Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, in healthy adults.",[115],"Healthy","COMPLETED","2013-07-29",{"date":119,"type":120},"2013-07-31","ESTIMATED",{"date":122,"type":11},"2012-10",{"date":124,"type":109},"2013-05",{"name":5,"class":6},1]