[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100229793":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":35,"sex":36,"minAge":37,"maxAge":11,"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},"BIII 890 CL single rising dose","EXPERIMENTAL",null,[13],"Drug: BIII 890 CL",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":11},"DRUG","BIII 890 CL",[9],{"type":21,"name":15,"description":11,"armGroupLabels":25,"otherNames":11},[15],{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100229793","phase-1-single-increasing-doses-of-biii-890-cl-in-healthy-young-male-volunteers-and-in-healthy-elderly-male-and-female-volunteers-100229793",false,"NCT02269215","Single Increasing Doses of BIII 890 CL in Healthy Young Male Volunteers and in Healthy Elderly Male and Female Volunteers","A Single Blind, Placebo-controlled, Parallel-group, Single Increasing Dose Tolerance Study in Healthy Young Male Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 12.5, 25, 50 mg\u002Fh, Infusion Time 1 hr; 50 mg\u002Fh, Infusion Time 2 Hrs) Followed by Maintenance Dose (Dosage: 6.25, 12.5, 25 mg\u002Fh, Infusion Time 5 Hrs; 30 mg\u002Fh, Infusion Time 4 Hrs) and in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIII 890 CL as Loading Dose (Dosage: 50 mg\u002Fh, Infusion Time 1 hr) Followed by Maintenance Dose (Dosage: 25 mg\u002Fh, Infusion Time 5 Hrs)","Inclusion Criteria:\n\n* Participants in the study should be healthy males, range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-Index) and healthy elderly males and females, \\> 60 years of age and be within +-25 % of their normal weight (Broca-Index)\n* In accordance with good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study\n\nExclusion Criteria:\n\n* Volunteers were excluded from the study if the results of the medical examination, laboratory tests or ECG recordings are judged by the investigator to differ significantly from normal clinical values\n* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Volunteers with diseases of the central nervous system (such as epilepsy), central nervous system (CNS) trauma in their medical history or with psychiatric disorders or neurological disorders\n* Volunteers with known history of relevant orthostatic hypotension, fainting spells or blackouts\n* Volunteers with chronic or relevant acute infections\n* Volunteers with history of allergy\u002Fhypersensitivity (including drug allergy) which was deemed relevant to the trial as, judged by the investigator\n* Volunteers who had taken a drug with a long half-life (≥ 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study\n* Volunteers who received any other drugs which could influence the results of the trial during the week prior to the start of the study\n* Volunteers who participated in another study with an investigational drug within the last two months preceding this study\n* Volunteers who smoke (\\> 10 cigarettes or 3 cigars or 3 pipes\u002Fday)\n* Volunteers who were not able to refrain from smoking on study days\n* Volunteers who drunk more than 60 g of alcohol per day\n* Volunteers who were dependent on drugs\n* Volunteers who participated in excessive physical activities (e.g. competitive sports) during the last week before the study\n* Volunteers who donated blood within the last 4 weeks (≥ 100 mL)",true,"ALL","21 Years",{"count":39,"type":40},73,"ACTUAL","INTERVENTIONAL",[43],"PHASE1","Safety, tolerability and pharmacokinetics of BIII 890",[46],"Healthy","COMPLETED","2014-10-20",{"date":50,"type":51},"2014-10-21","ESTIMATED",{"date":53,"type":11},"2000-01",{"name":5,"class":6}]