[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100190594":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":25,"locations":40,"responsibleParty":54,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1","EXPERIMENTAL","Subjects randomized to Sequence 1 will receive Treatment A followed by Treatment B. Treatment A is a single 2 mg oral dose of midazolam alone. Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991 and a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.",[13,14],"Drug: Midazolam","Drug: PD-0332991",{"label":16,"type":10,"description":17,"interventionNames":18},"Sequence 2","Subjects randomized to Sequence 2 will receive Treatment B followed by Treatment A with a washout of no less than 14 days in between.Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991 and a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose. There will be a minimum washout of 14 days prior to beginning Treatment A. Treatment A is a single 2 mg oral dose of midazolam alone.",[13,14],[20,26,30,33],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Midazolam","Treatment A includes a single 2 mg oral dose of midazolam alone. Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"PD-0332991","Treatment B includes 8 daily 125 mg oral doses of PD-0332991.",[9],{"type":21,"name":22,"description":31,"armGroupLabels":32,"otherNames":25},"Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.\n\nTreatment A includes a single 2 mg oral dose of midazolam alone.",[16],{"type":21,"name":27,"description":34,"armGroupLabels":35,"otherNames":25},"Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991.",[16],[37],{"name":38,"affiliation":5,"role":39},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Pfizer Investigational Site","South Miami","Florida","33143","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-80.29338,25.7076,{"lat":52,"lon":51},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100190594","phase-1-a-drug-drug-interaction-study-to-investigate-the-potential-for-multiple-doses-of-palbociclib-pd-0332991-to-alter-the-pharmacokinetics-of-oral-midazolam-in-adult-healthy-women-of-non-childbearing-potential-100190594",false,"NCT01756781","A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.","A Phase 1 Randomized, Open-Label, 2-Sequence, 2-Period Crossover Study Of The Effect Of Multiple Doses Of PD-0332991 On Midazolam Pharmacokinetics In Healthy Women of Non-Childbearing Potential","Inclusion Criteria:\n\n* Healthy females of non-child bearing potential between the ages of 18 and 65 years old.\n* A Body Mass Index (BMI) of 17.5 to 32.0 kg\u002Fm2 and a total body weight \\>50 kg (110 lbs).\n* A signed informed consent document.\n\nExclusion Criteria:\n\n* Any evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.\n* A positive urine drug screen.\n* Pregnant or nursing females.\n* Treatment with an investigational drug within 30 days or 5 half-lives of the first dose of study medication.",true,"FEMALE","18 Years","65 Years",{"count":68,"type":69},26,"ACTUAL","INTERVENTIONAL",[72],"PHASE1","This is a drug-drug interaction study to compare the pharmacokinetics of a 2 mg oral dose of midazolam in adult healthy women of non-childbearing potential when administered alone and when administered along with 8 daily 125 mg doses of PD-0332991. Volunteers will be randomized to one of two sequences. Volunteers in sequence 1 will receive midazolam alone in treatment period 1, followed by multiple dose PD-0332991 and midazolam in treatment period 2. Volunteers randomized to sequence 2 will receive multiple dose PD-0332991 and midazolam in treatment period 1, and following a washout period of no less than 14 days they will receive midazolam alone in treatment period 2.",[75],"Healthy",[27,22,77,78],"Drug-Drug Interaction Study","Healthy Adult Volunteer","COMPLETED","2015-10-06",{"date":82,"type":83},"2015-10-08","ESTIMATED",{"date":85,"type":25},"2013-05",{"date":87,"type":69},"2013-07",{"name":5,"class":6},1]