[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100300747":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":33,"responsibleParty":46,"collaborators":30,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":30,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":30,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":30,"overallStatus":67,"whyStopped":68,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Boehringer Ingelheim","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"BI 473494 35 μg","EXPERIMENTAL","Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.",[19],"Drug: BI 473494",{"label":21,"type":16,"description":22,"interventionNames":23},"BI 473494 75 μg","Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.",[19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","BI 473494","Solution for injection",[15,21],null,{"type":26,"name":9,"description":28,"armGroupLabels":32,"otherNames":30},[9],[34],{"facility":35,"status":30,"city":36,"state":30,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":30},"CRS Clinical Research Services Mannheim GmbH","Mannheim","68167","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],8.46694,49.4891,{"lat":44,"lon":43},{"type":47,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100300747","phase-1-evaluation-of-safety-and-tolerability-of-single-rising-doses-of-bi-473494-in-healthy-subjects-100300747",true,"NCT03195088","Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 473494 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)","Inclusion Criteria:\n\n* Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure \\[BP\\], Pulse Rate \\[PR\\]), 12-lead Electrocardiogram \\[ECG\\], and clinical laboratory tests\n* Age of 18 to 45 years (incl.)\n* Body Mass Index \\[BMI\\] of 20.0 to 29.9 kg\u002Fm2 (incl.)\n* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice \\[GCP\\] and local legislation\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including Blood Pressure \\[BP\\], Pulse Rate \\[PR\\] or Electrocardiogram \\[ECG\\]) is deviating from normal and judged as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 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 as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT\u002FQTc interval prolongation)\n* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n* Further exclusion criteria apply","MALE","18 Years","45 Years",{"count":59,"type":60},16,"ACTUAL","INTERVENTIONAL",[63],"PHASE1","The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects.\n\nThe secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.",[66],"Healthy","TERMINATED","Terminated (Business Reasons)","2022-06-28",{"date":71,"type":60},"2022-07-14",{"date":73,"type":60},"2017-07-27",{"date":75,"type":60},"2017-11-14",{"name":5,"class":6},1]