[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434251":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":24,"centralContacts":11,"locations":27,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BMS-986166 + Oral contraceptive","EXPERIMENTAL",null,[13,14],"Drug: BMS-986166","Drug: Oral contraceptive",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","BMS-986166","Specified dose on specified days",[9],{"type":17,"name":22,"description":19,"armGroupLabels":23,"otherNames":11},"Oral contraceptive",[9],[25],{"name":5,"affiliation":5,"role":26},"STUDY_DIRECTOR",[28],{"facility":29,"status":11,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":11},"West Coast Clinical Trials Global","Cypress","California","90630","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-118.03729,33.81696,{"lat":39,"lon":38},{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100434251","phase-1-a-study-to-characterize-the-drug-levels-of-an-oral-contraceptive-with-and-without-bms-986166-in-healthy-female-participants-of-childbearing-potential-100434251",false,"NCT04934696","A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential","A Phase 1 Study to Characterize the Effects of BMS-986166 on the Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone in Healthy Female Participants","For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Nonpregnant, nonlactating Women of Childbearing Potential (WOCBP) who are healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations will be eligible to participate in the study.\n* Body mass index (BMI) of 18.0 to 32.0 kg\u002Fm². BMI = weight (kg)\u002F(height\\[m\\])² for participants.\n* Participant must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness judged to be clinically significant by the investigator and\u002For Sponsor Medical Monitor.\n* History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease.\n* Any acute or chronic bacterial, fungal (except history of tinea pedis or ongoing onychomycosis will not be exclusionary) or viral infection within the last 3 months prior to screening, as well as any febrile illness or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",true,"FEMALE","18 Years","45 Years",{"count":55,"type":56},25,"ACTUAL","INTERVENTIONAL",[59],"PHASE1","The purpose of this study is to investigate the potential for a drug-drug interaction (DDI) when BMS-986166 and hormonal oral contraceptives are co-administered.",[62],"Healthy Participants",[62,18],"COMPLETED","2022-03-07",{"date":67,"type":56},"2022-03-18",{"date":69,"type":56},"2021-08-03",{"date":71,"type":56},"2022-01-25",{"name":5,"class":6},1]