[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100207226":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":32,"responsibleParty":45,"collaborators":31,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":31,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":31,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":69,"whyStopped":31,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"selumetinib 75mg (oral capsule fasted)","EXPERIMENTAL","Volunteers will recieve selumetinib 75mg administered by mouth, as a capsule, in a fasted state.",[13],"Drug: selumetinib (oral)",{"label":15,"type":10,"description":16,"interventionNames":17},"selumetinib 75mg (oral capusle fed)","Volunteers will receive selumetinib 75mg administered by mouth, as a capsule, in a fed state.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","selumetinib (oral)","Volunteers will receive: 75 mg selumetinib oral dose in a fasted state (Treatment A) followed by a second 75 mg selumetinib oral dose in the fed state (Treatment B) with a washout period of at least 7 days between doses, or: 75 mg selumetinib oral dose in the fed state (Treatment B) followed by a second 75 mg selumetinib oral dose in the fasted state (Treatment A) with a washout period of at least 7 days between doses.",[9,15],[25],"AZD6244",[27],{"name":28,"affiliation":29,"role":30},"Eleanor Lisbon, MD","Quintiles 6700 W 115th Street, Kansas, US","PRINCIPAL_INVESTIGATOR",null,[33],{"facility":34,"status":31,"city":35,"state":36,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":31},"Research Site","Overland Park","Kansas","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-94.67079,38.98223,{"lat":43,"lon":42},{"type":46,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100207226","phase-1-to-assess-the-effect-of-food-on-the-pharmacokinetics-of-selumetinib-azd6244-arry-142886-hyd-sulfate-in-healthy-male-volunteers-100207226",false,"NCT01974349","To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers","A Phase I, Randomized, Open-label, Single-center, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male 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 (inclusive). 2. Must not have smoked or used nicotine products within the previous 3 months. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL\u002Fmin using the Cockcroft-Gault formula.\n\nExclusion Criteria: 1. Current or past history of central serous retinopathy or retinal vein thrombosis, intra-ocular pressure greater than 21 mmHg or uncontrolled glaucoma. 2. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs, or ECG at baseline in the opinion of the investigator. 3. History or presence of any clinically significant disease or disorder in the opinion of the investigator. 4. Subjects of Japanese or non-Japanese Asian ethnicity. 5. Subjects where any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (e.g., China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable.",true,"MALE","18 Years","45 Years",{"count":59,"type":60},39,"ACTUAL","INTERVENTIONAL",[63],"PHASE1","Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers",[66],"Solid Tumours",[68],"Phase I, healthy, pharmacokinetics, food effect.","COMPLETED","2014-08-12",{"date":72,"type":73},"2014-08-13","ESTIMATED",{"date":75,"type":31},"2013-11",{"date":77,"type":60},"2014-02",{"name":5,"class":6},1]