[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100229758":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":11,"leadSponsor":70,"locationsCount":11},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"BILN 2061 ZW single rising doses","EXPERIMENTAL",null,[13],"Drug: BILN 2061 ZW single rising doses",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",{"label":20,"type":10,"description":11,"interventionNames":21},"BILN 2061 ZW fixed dose fed",[22,23],"Drug: BILN 2061 ZW fixed dose","Other: Standardized breakfast",{"label":25,"type":26,"description":11,"interventionNames":27},"BILN 2061 ZW fixed dose fasted","ACTIVE_COMPARATOR",[22],[29,32,34,37],{"type":30,"name":9,"description":11,"armGroupLabels":31,"otherNames":11},"DRUG",[9],{"type":30,"name":15,"description":11,"armGroupLabels":33,"otherNames":11},[15],{"type":30,"name":35,"description":11,"armGroupLabels":36,"otherNames":11},"BILN 2061 ZW fixed dose",[25,20],{"type":38,"name":39,"description":11,"armGroupLabels":40,"otherNames":11},"OTHER","Standardized breakfast",[20],{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100229758","phase-1-safety-tolerance-and-pharmacokinetics-of-biln-2061-zw-in-healthy-male-subjects-combined-with-preliminary-evaluation-of-food-effect-100229758",false,"NCT02268760","Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect","Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 5 mg, 20 mg, 60 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, 1000 mg, 1200 mg, 1500 mg, 2000 mg and 2400 mg BILN 2061 ZW (PEG 400: Ethanol Solution) in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect of the Dose of 200 mg (Two-Stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Part and Subsequent Open Intraindividual Comparison Part)","Inclusion Criteria:\n\n* Healthy male subjects as determined by results of screening\n* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation\n* Age ≥ 18 and ≤ 50 years\n* Broca ≥ - 20 % and ≤ + 20 %\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance\n* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection\n* History of orthostatic hypotension, fainting spells and blackouts\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* Chronic or relevant acute infections\n* History of allergy\u002Fhypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator\n* Intake of drugs with a long half-life (\\> 24 hours) within 1 month prior to administration\n* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial\n* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial\n* Smoker (\\> 10 cigarettes or 3 cigars or 3 pipes\u002Fday) or inability to refrain from smoking on trial days\n* Alcohol abuse (\\> 60 g\u002Fday)\n* Drug abuse\n* Blood donation within 1 month prior to administration or during the trial\n* Excessive physical activities within 5 days prior to administration or during the trial\n* Any laboratory value outside the clinically accepted reference range and of clinical relevance\n* History of any familial bleeding disorder",true,"MALE","18 Years","50 Years",{"count":55,"type":56},103,"ACTUAL","INTERVENTIONAL",[59],"PHASE1","To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW\n\n1. In rising single doses\n2. With and without a 64 g fat breakfast at one selected dose",[62],"Healthy","COMPLETED","2014-10-17",{"date":66,"type":67},"2014-10-20","ESTIMATED",{"date":69,"type":11},"2001-06",{"name":5,"class":6}]