[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100195510":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":33,"responsibleParty":34,"collaborators":33,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":33,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":33,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":33,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":33},{"fullName":5,"class":6},"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Canagliflozin + simvastatin","EXPERIMENTAL","Each volunteer will receive a single dose of simvastatin on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 2 through 6. On Day 7 volunteers will receive a single dose of simvastatin in combination with a single dose of canagliflozin.",[13,14],"Drug: Simvastatin","Drug: Canagliflozin (JNJ-28431754)",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Simvastatin","One 40 mg tablet taken orally (by mouth) on Day 1 and Day 7.",[9],[22],"Zocor",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Canagliflozin (JNJ-28431754)","One 300 mg dose (ie, one 100 mg and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Days 2 through Day 7.",[9],[28],"JNJ-28431754",[30],{"name":31,"affiliation":5,"role":32},"Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial","STUDY_DIRECTOR",null,{"type":35,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100195510","phase-1-a-study-to-assess-the-effects-of-canagliflozin-jnj-28431754-on-the-pharmacokinetics-pharmacodynamics-and-safety-of-simvastatin-in-healthy-volunteers-100195510",false,"NCT01821027","A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Simvastatin in Healthy Volunteers","A Open-Label, Single Sequence Study to Assess the Pharmacokinetics and Pharmacodynamics of Simvastatin Alone and of Simvastatin in Combination With JNJ-28431754 in Healthy Adult Subjects","Inclusion Criteria:\n\n* Volunteers must have a body mass index (BMI) (weight in kg\u002Fheight in m2) between 18 and 30 kg\u002Fm2 (inclusive), and body weight not less than 50 kg\n* Volunteers must be non-smokers\n\nExclusion Criteria:\n\n\\- History of, or current active illness, considered to be clinically significant by the Investigator, or any other illness that the Investigator considers should exclude the patient from the study, or that could interfere with the interpretation of the study results",true,"ALL","18 Years","55 Years",{"count":48,"type":49},22,"ACTUAL","INTERVENTIONAL",[52],"PHASE1","The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of simvastatin.",[55],"Healthy",[55,24,57,58,59],"Pharmacokinetics","Pharmacodynamics","Simvastatin (ZOCOR)","COMPLETED","2013-03-26",{"date":63,"type":64},"2013-03-29","ESTIMATED",{"date":66,"type":33},"2008-08",{"date":68,"type":49},"2008-09",{"name":5,"class":6}]