[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100189153":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":24,"responsibleParty":36,"collaborators":20,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":20,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":20,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":20,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All patients","EXPERIMENTAL","For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir",[13],"Drug: BI 207127 + faldaprevir",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","BI 207127 + faldaprevir","fixed dose combination",[9],null,[22],{"name":5,"affiliation":5,"role":23},"STUDY_CHAIR",[25],{"facility":26,"status":20,"city":27,"state":20,"zip":20,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":20},"1241.35.1 Boehringer Ingelheim Investigational Site","Mannheim","Germany","DE",{"type":31,"coordinates":32},"Point",[33,34],8.46694,49.4891,{"lat":34,"lon":33},{"type":37,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100189153","phase-1-safety-tolerability-and-pharmacokinetics-of-different-multiple-doses-of-bi-207127-bid-and-multiple-doses-of-bi-207127-combined-with-faldaprevir-in-healthy-male-and-female-subjects-100189153",true,"NCT01737996","Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects","An Open-label, Multiple Dose Study to Assess Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID Administered Orally for 9 Days (Part 1) and Multiple Doses of BI 207127 Combined With Faldaprevir Administered Orally for 16 Days (Part 2) in Healthy Male and Female Subjects","Inclusion criteria:\n\n1\\. healthy male and female subjects\n\nExclusion criteria:\n\n1\\. Any relevant deviation from healthy conditions","ALL","18 Years","50 Years",{"count":49,"type":50},32,"ACTUAL","INTERVENTIONAL",[53],"PHASE1","The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.",[56],"Healthy","COMPLETED","2016-03-10",{"date":60,"type":61},"2016-04-08","ESTIMATED",{"date":63,"type":20},"2012-11",{"date":65,"type":50},"2013-03",{"name":5,"class":6},1]