[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100216357":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":54,"centralContacts":32,"locations":59,"responsibleParty":72,"collaborators":32,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":32,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":32,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":96,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"selumetinib; itraconazole; selumetinib + itraconazole","EXPERIMENTAL","Volunteers will receive selumetinib 25mg alone; itraconazole 200mg pre-dosing; selumetinib 25mg and itraconazole 200mg; all adminstered by mouth as a capsule",[13,14],"Drug: selumetinib","Drug: itraconazole",{"label":16,"type":10,"description":17,"interventionNames":18},"selumetinib; fluconazole; selumetinib + fluconazole","Volunteers will receive selumetinib 25mg alone administered by mouth as a capsule; fluconazole 400mg and fluconazole 200mg pre-dosing, administered by mouth as a tablet; selumetinib 25mg and fluconazole 200mg.",[13,19],"Drug: fluconazole",[21,28,33,36,40,44,48,51],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","selumetinib","Volunteers will recieve single oral dose of 25mg selumetinib in sequence 1, treatment A",[9],[27],"(AZD6244; ARRY-142866) ( Hyd-Sulfate)",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"itraconazole","Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B:",[9],null,{"type":22,"name":29,"description":34,"armGroupLabels":35,"otherNames":32},"Volunteers will recieve a single morning dose of 200mg itraconazole on Day 8 and twice daily doses of 200mg itraconazole on Day 8 to Day 11; sequence 1 treatment C.",[9],{"type":22,"name":23,"description":37,"armGroupLabels":38,"otherNames":39},"Volunteers willl recieve a single oral dose of 25 mg selumetinib (4 hours fasted state) on Day 8; sequence 1 treatment C.",[9],[27],{"type":22,"name":23,"description":41,"armGroupLabels":42,"otherNames":43},"Volunteers will recieve single oral dose of 25mg selumetinib in sequence 2, treatment A.",[16],[27],{"type":22,"name":45,"description":46,"armGroupLabels":47,"otherNames":32},"fluconazole","Volunteers will recieve a single dose of 400 mg fluconazole on Day 1 and daily doses of 200 mg fluconazole on Day 2 to Day 7; sequence 2 treatment D.",[16],{"type":22,"name":45,"description":49,"armGroupLabels":50,"otherNames":32},"Volunteers will receive a morning dose of 200mg fluconazole on Day 8 and daily doses of 200mg fluconazole on Day 8 to Day 11; sequence 2 treatment E",[16],{"type":22,"name":23,"description":52,"armGroupLabels":53,"otherNames":32},"Volunteers will receive a single dose of 25mg selumetinib (4 hours fasted state) on Day 8; sequence 2 treatment E",[16],[55],{"name":56,"affiliation":57,"role":58},"David R Mathews, MD","Quintiles 6700 W 115th Street, Kansas, US","PRINCIPAL_INVESTIGATOR",[60],{"facility":61,"status":32,"city":62,"state":63,"zip":32,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":32},"Research Site","Overland Park","Kansas","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-94.67079,38.98223,{"lat":70,"lon":69},{"type":73,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100216357","phase-1-to-assess-the-effect-of-itraconazole-and-fluconazole-on-the-pharmacokinetics-of-selumetinib-in-healthy-male-volunteers-100216357",false,"NCT02093728","To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers","A Phase I, Open-label, Single-center Study to Assess the Effect of the CYP3A4 Inhibitor Itraconazole and the CYP2C19 Inhibitor Fluconazole on the Pharmacokinetics of a 25 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Volunteers Aged 18 to 45 Years","Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg\u002Fm2 (inclusive) and weigh at least 50 kg and no more than 100 kg. 2. Female subjects of non-childbearing potential. 3. Have a calculated creatinine clearance (CrCL) \\>50 mL\u002Fmin using the Cockcroft-Gault formula.\n\nExclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese. Asian (ie, China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable. 3. Current or past history of central serous retinopathy or retinal vein thrombosis,intra-ocular pressure \\>21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.",true,"ALL","18 Years","45 Years",{"count":86,"type":87},26,"ACTUAL","INTERVENTIONAL",[90],"PHASE1","Study to assess the effect of Itraconazole and Fluconazole on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142866) ( Hyd-Sulfate) in Healthy Male Volunteers",[93],"Solid Tumours",[95],"Phase I, healthy, pharmacokinetics","COMPLETED","2015-06-29",{"date":99,"type":100},"2015-06-30","ESTIMATED",{"date":102,"type":32},"2014-04",{"date":104,"type":87},"2014-06",{"name":5,"class":6},1]