[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100230115":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":25,"collaborators":11,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":11,"eligibilityCriteria":33,"healthyVolunteers":34,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":11,"leadSponsor":54,"locationsCount":11},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BI 11054 CL","EXPERIMENTAL",null,[13],"Drug: BI 11054 CL",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,23],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":11},"DRUG",[9],{"type":21,"name":15,"description":11,"armGroupLabels":24,"otherNames":11},[15],{"type":26,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100230115","phase-1-safety-tolerability-and-pharmacokinetics-of-single-rising-inhaled-doses-of-bi-11054-cl-administered-with-the-respimat-in-healthy-male-volunteers-100230115",false,"NCT02273401","Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses of BI 11054 CL Administered With the Respimat® in Healthy Male Volunteers","A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Inhaled Doses (0.5 μg to 70 μg Administered With the Respimat®) of BI 11054 CL in Healthy Male Volunteers","Inclusion Criteria:\n\n* Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.\n* Age ≥21 and ≤50 years\n* Body mass index (BMI) ≥18.5 and \\\u003C30 kg\u002Fm2\n* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation\n\nExclusion Criteria:\n\n* Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance\n* Evidence of a clinically relevant concomitant disease\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders\n* History of relevant orthostatic hypotension, fainting spells or blackouts\n* Chronic or relevant acute infections\n* History of relevant allergy\u002Fhypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator\n* Intake of drugs with a long half-life (\\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation\n* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomisation\n* Participation in another trial with an investigational drug within 2 months prior to randomisation\n* Smoker (\\>10 cigarettes or \\>3 cigars or \\>3 pipes\u002Fday)\n* Inability to refrain from smoking on trial days as judged by the investigator\n* Alcohol abuse (more than 40 g alcohol a day)\n* Drug abuse\n* Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)\n* Excessive physical activities within 1 week prior to randomisation or during the trial\n* Any laboratory value outside the reference range that is of clinical relevance\n* Inability to comply with dietary regimen of the study centre\n\nThe following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:\n\n* Asthma or history of pulmonary hyperreactivity\n* Hyperthyrosis\n* Allergic rhinitis in need of treatment\n* Clinically relevant cardiac arrhythmia\n* Paroxysmal tachycardia (\\>100 beats per minute)",true,"MALE","21 Years","50 Years",{"count":39,"type":40},96,"ACTUAL","INTERVENTIONAL",[43],"PHASE1","To investigate safety, tolerability, and pharmacokinetics of BI 11054",[46],"Healthy","COMPLETED","2014-10-23",{"date":50,"type":51},"2014-10-24","ESTIMATED",{"date":53,"type":11},"2008-01",{"name":5,"class":6}]