[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509140":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":31,"centralContacts":35,"locations":36,"responsibleParty":50,"collaborators":35,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":35,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":35,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":73,"whyStopped":35,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Venetoclax Sequence 1","EXPERIMENTAL","Participants will receive whole venetoclax, followed by crushed venetoclax, and completed with ground venetoclax for a 15 day period.",[13],"Drug: Venetoclax",{"label":15,"type":10,"description":16,"interventionNames":17},"Venetoclax Sequence 2","Participants will receive crushed venetoclax, followed by ground venetoclax, and completed with whole venetoclax for a 15 day period.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Venetoclax Sequence 3","Participants will receive ground venetoclax, followed by whole venetoclax, and completed with crushed venetoclax for a 15 day period.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Venetoclax","Oral; Tablet",[9,15,19],[29,30],"ABT-199","Venclaxta",[32],{"name":33,"affiliation":5,"role":34},"ABBVIE INC.","STUDY_DIRECTOR",null,[37],{"facility":38,"status":35,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":35},"Acpru \u002FId# 255783","Grayslake","Illinois","60030","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-88.04175,42.34447,{"lat":48,"lon":47},{"type":51,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100509140","phase-1-study-to-assess-adverse-events-and-compare-how-crushed-ground-and-intact-oral-tablets-venetoclax-moves-through-the-body-of-healthy-female-adult-volunteers-100509140",false,"NCT05909553","Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers","A Phase 1, Open-Label Study to Evaluate the Effect of Crushing and Grinding on the Bioavailability of Venetoclax Tablet in Healthy Adult Female Subjects","Inclusion Criteria:\n\n* Must either be: postmenopausal, permanently surgically sterile, or perimenopausal or premenopausal and practicing a method of birth control until at least 1 month after the last dose of study drug.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).\n\nExclusion Criteria:\n\n* Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect her participating in this study.\n* History of any clinically significant sensitivity or allergy to any medication or food.\n* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.",true,"FEMALE","18 Years","65 Years",{"count":64,"type":65},15,"ACTUAL","INTERVENTIONAL",[68],"PHASE1","The objective of this study is to assess the oral bioavailability of crushed and ground venetoclax commercial tablets relative to the intact venetoclax commercial tablets under fed condition in healthy female participants.",[71],"Healthy Volunteers",[71,25,29],"COMPLETED","2023-11-29",{"date":76,"type":65},"2023-12-01",{"date":78,"type":65},"2023-06-15",{"date":80,"type":65},"2023-09-22",{"name":5,"class":6},1]