[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356896":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":28,"collaborators":24,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":24,"eligibilityCriteria":36,"healthyVolunteers":37,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":24,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":24,"overallStatus":50,"whyStopped":24,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":24},{"fullName":5,"class":6},"Wockhardt","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"WCK 4873","EXPERIMENTAL","100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets)",[13],"Drug: WCK 4873",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Visually matching placebo",[19],"Drug: Placebo Oral Tablet",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":26,"description":17,"armGroupLabels":27,"otherNames":24},"Placebo Oral Tablet",[15],{"type":29,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100356896","phase-1-the-safety-tolerability-and-pharmacokinetics-of-single-ascending-doses-and-the-effect-of-food-on-oral-wck-4873-in-healthy-adult-volunteers-100356896",false,"NCT03926962","The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers","Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers","Inclusion Criteria:\n\n* BMI : 18-30 kg\u002Fm2 (Body Mass Index \\[BMI\\] \\[kg\u002Fm2\\] = Body weight \\[kg\\] Height2 \\[m2\\])\n* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, \"powerdrinks\"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge\n* Medical history without major pathology\n\nExclusion Criteria:\n\n* Evidence of clinically relevant pathology\n* Mental handicap\n* History of relevant drug and\u002For food allergies\n* Regular\u002Froutine treatment with non-topical medications within 30 days prior to entry into the clinical research center\n* Smoking within 60 days prior to drug administration and through the follow-up visit\n* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)",true,"ALL","18 Years","65 Years",{"count":42,"type":43},67,"ACTUAL","INTERVENTIONAL",[46],"PHASE1","This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.",[49],"Healthy","COMPLETED","2019-04-24",{"date":53,"type":43},"2019-04-25",{"date":55,"type":43},"2013-03-14",{"date":57,"type":43},"2013-07-13",{"name":5,"class":6}]