[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100212772":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":44,"centralContacts":40,"locations":49,"responsibleParty":62,"collaborators":40,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":40,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":40,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":86,"whyStopped":40,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"selumetinib 75mg.","EXPERIMENTAL","Volunteers will receive selumetinib 75mg administered by mouth, as a capsule",[13],"Drug: selumetinib",{"label":15,"type":16,"description":17,"interventionNames":18},"rifampicin 600mg.","OTHER","Volunteers will receive rifampicin 600mg administered by mouth, as a capsule",[19],"Drug: rifampicin",{"label":21,"type":10,"description":22,"interventionNames":23},"selumetinib 75mg and rifampicin 600mg","Volunteers will receive selumetinib 75mg and rifampicin 600mg, by mouth, as a capsule",[13,19],[25,32,37,41],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","selumetinib","Volunteers will receive a single oral dose of 75 mg selumetinib on day 1 (Treatment A).",[9],[31],"AZD6244",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"rifampicin","Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B).",[15],[31],{"type":26,"name":27,"description":38,"armGroupLabels":39,"otherNames":40},"On day 12 volunteers will receive a single oral dose of 75 mg selumetinib (Treatment C).",[21],null,{"type":26,"name":33,"description":42,"armGroupLabels":43,"otherNames":40},"On day 12 volunteers will receive a single oral dose of 600 mg rifampicin. Once daily rifampicin administrations will continue through to Day 14 (Treatment C).",[21],[45],{"name":46,"affiliation":47,"role":48},"Eleanor Lisbon, MD","Quintiles 6700 W 115th Street, Kansas, US","PRINCIPAL_INVESTIGATOR",[50],{"facility":51,"status":40,"city":52,"state":53,"zip":40,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":40},"Research Site","Overland Park","Kansas","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-94.67079,38.98223,{"lat":60,"lon":59},{"type":63,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100212772","phase-1-to-assess-the-effect-of-rifampicin-on-the-pharmacokinetics-of-selumetinib-in-healthy-male-volunteers-100212772",false,"NCT02046850","To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers","A Phase I Open-label, Single-center Study to Assess the Effect of the CYP3A4 Inducer Rifampicin on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (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 (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. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, 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 greater than 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. 5. History of presence of any clinically significant disease or disorder in the opinion of the investigator.",true,"MALE","18 Years","45 Years",{"count":76,"type":77},24,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers",[83],"Solid Tumours",[85],"Phase I, healthy, pharmacokinetics,","COMPLETED","2014-04-28",{"date":89,"type":77},"2014-04-29",{"date":91,"type":40},"2014-02",{"date":93,"type":94},"2014-04","ACTUAL",{"name":5,"class":6},1]