[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100210458":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":11,"locations":35,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"1 Cyclosporine + Faldaprevir","EXPERIMENTAL",null,[13,14],"Drug: Faldaprevir","Drug: Cyclosporine",{"label":16,"type":10,"description":11,"interventionNames":17},"2 Tacrolimus + Faldaprevir",[13,18],"Drug: Tacrolimus",[20,24,26,29],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":11},"DRUG","Faldaprevir",[9],{"type":21,"name":22,"description":11,"armGroupLabels":25,"otherNames":11},[16],{"type":21,"name":27,"description":11,"armGroupLabels":28,"otherNames":11},"Cyclosporine",[9],{"type":21,"name":30,"description":11,"armGroupLabels":31,"otherNames":11},"Tacrolimus",[16],[33],{"name":5,"affiliation":5,"role":34},"STUDY_CHAIR",[36],{"facility":37,"status":11,"city":38,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":11},"1241.61.1 Boehringer Ingelheim Investigational Site","Mannheim","Germany","DE",{"type":42,"coordinates":43},"Point",[44,45],8.46694,49.4891,{"lat":45,"lon":44},{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100210458","phase-1-investigation-of-potential-drug-drug-interactions-between-faldaprevir-and-the-immunosuppressant-drugs-cyclosporine-or-tacrolimus-100210458",true,"NCT02016625","Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus","Investigation of Potential Drug-drug Interactions Between Faldaprevir and Immunosuppressants (Cyclosporine and Tacrolimus) in Healthy Male and Female Subjects (Open-label, Fixed-sequence Trial)","Inclusion criteria:\n\n* Healthy males or females subjects\n* Age 18 to 50 years (incl.)\n* Body mass index (BMI) 18.5 to 29.9 kg\u002Fm2 (incl.)\n* Signed and dated written informed consent prior to admission to the study\n\nExclusion criteria:\n\n* Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and judged clinically relevant by the investigator.\n* Systolic blood pressure (BP) less than 100 mmHg and more than 140 mmHg.\n* Diastolic BP less than 60 mmHg and more than 90 mmHg.\n* Pulse rate (PR) less than 50 bpm and more than 90 bpm.\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n* Any evidence of a concomitant disease judged clinically relevant by the investigator\n* Positive QuantiFERON-TB Gold In-Tube","ALL","18 Years","50 Years",{"count":60,"type":61},32,"ACTUAL","INTERVENTIONAL",[64],"PHASE1","The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus",[67],"Healthy","COMPLETED","2016-04-21",{"date":71,"type":72},"2016-05-23","ESTIMATED",{"date":74,"type":11},"2013-12",{"date":76,"type":61},"2014-04",{"name":5,"class":6},1]