[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100159443":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":51,"centralContacts":48,"locations":48,"responsibleParty":54,"collaborators":48,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":48,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":48,"studyType":69,"phases":70,"briefSummary":60,"conditions":72,"keywords":48,"overallStatus":74,"whyStopped":48,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":48,"leadSponsor":81,"locationsCount":48},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,14,17,20,23,26,29,32,35,38],{"label":9,"type":10,"description":11,"interventionNames":12},"BI 137882 Dose 1","EXPERIMENTAL","Powder for oral solution",[13],"Drug: BI 137882",{"label":15,"type":10,"description":11,"interventionNames":16},"BI 137882 Dose 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"BI 137882 Dose 3",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"BI 137882 Dose 4",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"BI 137882 Dose 5",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"BI 137882 Dose 6",[13],{"label":30,"type":10,"description":11,"interventionNames":31},"BI 137882 Dose 7",[13],{"label":33,"type":10,"description":11,"interventionNames":34},"BI 137882 Dose 8",[13],{"label":36,"type":10,"description":11,"interventionNames":37},"BI 137882 Dose 9",[13],{"label":39,"type":40,"description":11,"interventionNames":41},"Placebo","PLACEBO_COMPARATOR",[42],"Drug: Placebo",[44,49],{"type":45,"name":46,"description":11,"armGroupLabels":47,"otherNames":48},"DRUG","BI 137882",[9,15,18,21,24,27,30,33,36],null,{"type":45,"name":39,"description":11,"armGroupLabels":50,"otherNames":48},[39],[52],{"name":5,"affiliation":5,"role":53},"STUDY_CHAIR",{"type":55,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100159443","phase-1-safety-tolerability-and-pharmacokinetics-of-single-rising-oral-doses-of-bi-137882-in-healthy-male-volunteers-100159443",true,"NCT01348165","Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers","Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers (A Randomised, Single-blind, Placebo-controlled Phase I Study)","Inclusion criteria:\n\n1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests\n2. Age 21 to 50 years\n3. BMI 18.5 to 29.9 kg\u002Fm2 (Body Mass Index)\n4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.\n\nExclusion criteria:\n\n1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance\n2. Any evidence of a clinically relevant concomitant disease\n3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n4. Surgery of the gastrointestinal tract (except appendectomy)\n5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n6. History of relevant orthostatic hypotension, fainting spells or blackouts.\n7. Chronic or relevant acute infections\n8. History of relevant allergy\u002Fhypersensitivity (including allergy to drug or its excipients)\n9. Intake of drugs with a long half-life (\\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial\n10. Use of drugs which might reasonably influence the results of the trial or that prolong the QT\u002FQTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial\n11. Participation in another trial with an investigational drug within two months prior to administration or during the trial\n12. Smoker (more than 10 cigarettes \u002Fday)\n13. Inability to refrain from smoking on trial days\n14. Alcohol abuse (more than 20 g\u002Fday)\n15. Drug abuse\n16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)\n17. Excessive physical activities (within one week prior to administration or during the trial)\n18. Any laboratory value outside the reference range that is of clinical relevance\n19. Inability to comply with dietary regimen of trial site\n20. A marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>450 ms);\n21. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)","MALE","21 Years","50 Years",{"count":67,"type":68},40,"ACTUAL","INTERVENTIONAL",[71],"PHASE1",[73],"Healthy","TERMINATED","2016-08-04",{"date":77,"type":78},"2016-09-16","ESTIMATED",{"date":80,"type":48},"2011-05",{"name":5,"class":6}]