[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100153444":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":71,"centralContacts":49,"locations":49,"responsibleParty":76,"collaborators":49,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":49,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":49,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":105,"whyStopped":49,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":49},{"fullName":5,"class":6},"Tibotec Pharmaceuticals, Ireland","INDUSTRY",[8,14,20,25,29,33,38],{"label":9,"type":10,"description":11,"interventionNames":12},"001","EXPERIMENTAL","TMC435 2 capsules of 75 mg once daily for 7 days in Treatment A",[13],"Drug: TMC435",{"label":15,"type":16,"description":17,"interventionNames":18},"002","OTHER","Placebo for TMC435 2 placebo capsules once daily for 7 days in Treatment A",[19],"Drug: Placebo for TMC435",{"label":21,"type":16,"description":22,"interventionNames":23},"003","Placebo for moxifloxacin 1 placebo tablet on Day 7 of Treatments A B and D",[24],"Drug: Placebo for moxifloxacin",{"label":26,"type":10,"description":27,"interventionNames":28},"004","TMC435 2 capsules of 75 mg and 2 capsules of 100 mg once daily for 7 days in Treatment B",[13],{"label":30,"type":16,"description":31,"interventionNames":32},"005","Placebo for TMC435 4 placebo capsules once daily for 7 days in Treatment C",[19],{"label":34,"type":16,"description":35,"interventionNames":36},"006","Moxifloxacin 1 tablet of 400 mg on Day 7 of Treatment C",[37],"Drug: Moxifloxacin",{"label":39,"type":40,"description":41,"interventionNames":42},"007","PLACEBO_COMPARATOR","Placebo for TMC435 4 placebo capsules once daily for 7 days in Treatment D",[19],[44,50,54,57,60,64,68],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","TMC435","2 capsules of 75 mg once daily for 7 days in Treatment A",[9],null,{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"Placebo for TMC435","4 placebo capsules once daily for 7 days in Treatment C",[30],{"type":45,"name":46,"description":55,"armGroupLabels":56,"otherNames":49},"2 capsules of 75 mg and 2 capsules of 100 mg once daily for 7 days in Treatment B",[26],{"type":45,"name":51,"description":58,"armGroupLabels":59,"otherNames":49},"2 placebo capsules once daily for 7 days in Treatment A",[15],{"type":45,"name":61,"description":62,"armGroupLabels":63,"otherNames":49},"Moxifloxacin","1 tablet of 400 mg on Day 7 of Treatment C",[34],{"type":45,"name":65,"description":66,"armGroupLabels":67,"otherNames":49},"Placebo for moxifloxacin","1 placebo tablet on Day 7 of Treatments A, B and D",[21],{"type":45,"name":51,"description":69,"armGroupLabels":70,"otherNames":49},"4 placebo capsules once daily for 7 days in Treatment D",[39],[72],{"name":73,"affiliation":74,"role":75},"Tibotec Pharmaceuticals Clinical Trial","Tibotec Pharmaceutical Limited","STUDY_DIRECTOR",{"type":77,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100153444","phase-1-tmc435-tidp16-c117-the-effect-of-tmc435-on-the-results-of-electrocardiograms-electric-recording-of-the-heart-in-healthy-volunteers-100153444",false,"NCT01269294","TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers","A Double-blind, Double-dummy, Randomized, 4-period Cross-over, Placebo- and Positive-controlled Study to Evaluate the Effect of TMC435 on the QTc Interval in Healthy Subjects","Inclusion Criteria:\n\n* Non-smokers for at least six months\n* Have a body mass index of 18.0 to 30.0 kg per square meter\n* Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening.\n\nExclusion Criteria:\n\n* Use of disallowed therapies, including over-the-counter products and dietary supplements\n* Any skin condition likely to interfere with ECG electrode placement or adhesion\n* History or evidence of current use of alcohol or recreational or narcotic drug use\n* Clinically relevant abnormality on ECG at screening or history of clinically relevant heart rhythm disturbances.",true,"ALL","18 Years","50 Years",{"count":90,"type":91},60,"ACTUAL","INTERVENTIONAL",[94],"PHASE1","The purpose of this study is to evaluate the effect of TMC435 on the results of electrocardiograms (ECGs) in healthy volunteers. An electrocardiogram is an electric recording of the heart. TMC435 is being investigated for the treatment of chronic hepatitis C virus infection.",[97],"Hepatitis C",[97,99,100,46,101,61,102,103,104],"TMC435-TiDP16-C117","TMC435-C117","HCV","ECG","QT","QTc","COMPLETED","2013-05-03",{"date":108,"type":109},"2013-05-06","ESTIMATED",{"date":111,"type":49},"2011-01",{"date":113,"type":91},"2011-07",{"name":5,"class":6}]