[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100224449":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":23,"locations":33,"responsibleParty":45,"collaborators":23,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":23,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":23,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":69,"whyStopped":23,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":23,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"H. Lundbeck A\u002FS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lu AF1167 capsule 0.5 mg","EXPERIMENTAL","Single oral dose (day 1)",[13],"Drug: Lu AF11167",{"label":15,"type":10,"description":16,"interventionNames":17},"Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule","Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8",[13,18],"Drug: Itraconazole",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":23},"DRUG","Lu AF11167",null,[15,9],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":23},"Itraconazole",[15],[29],{"name":30,"affiliation":31,"role":32},"Email contact via H. Lundbeck A\u002FS","LundbeckClinicalTrials@Lundbeck.com","STUDY_DIRECTOR",[34],{"facility":35,"status":23,"city":36,"state":23,"zip":23,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":23},"Covance","Leeds","United Kingdom","UK",{"type":40,"coordinates":41},"Point",[42,43],-1.54785,53.79648,{"lat":43,"lon":42},{"type":46,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100224449","phase-1-study-to-evaluate-the-effect-of-a-known-and-marketed-product-itraconazole-mycosis-treatment-on-lu-af11167-entering-the-body-and-subsequently-elimination-the-study-is-a-drug-drug-interaction-study-in-healthy-volunteers-100224449",false,"NCT02199431","Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.","Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4\u002F5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young Subjects","Inclusion Criteria:\n\n* Subjects be 18 years of age and 55 years of age and with a BMI \\>18.5 kg\u002Fm2 and \\\u003C30.0 kg\u002Fm2 at the Screening Visit. Women must not be pregnant or lactating.\n\nOther pre-defined inclusion and exclusion criteria may apply.",true,"ALL","18 Years","55 Years",{"count":59,"type":60},20,"ACTUAL","INTERVENTIONAL",[63],"PHASE1","The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4\u002F5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers",[66],"Healthy",[22,68],"Interaction","COMPLETED","2015-09-18",{"date":72,"type":73},"2015-09-21","ESTIMATED",{"date":75,"type":23},"2014-07",{"name":5,"class":6},1]