[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507851":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":36,"responsibleParty":70,"collaborators":35,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":35,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":35,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":92,"whyStopped":35,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Atogepant","EXPERIMENTAL","Participants will receive single dose of atogepant on Day 1.",[13],"Drug: Atogepant",{"label":15,"type":16,"description":17,"interventionNames":18},"Ubrogepant","ACTIVE_COMPARATOR","Participants will receive single dose of ubrogepant on Day 1.",[19],"Drug: Ubrogepant",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Oral Tablet",[9],[26],"QULIPTA",{"type":22,"name":15,"description":23,"armGroupLabels":28,"otherNames":29},[15],[30],"UBRELVY",[32],{"name":33,"affiliation":5,"role":34},"ABBVIE INC.","STUDY_DIRECTOR",null,[37,50,60],{"facility":38,"status":35,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":35},"Bio-Kinetic Clinical Applications, LLC \u002FID# 255452","Springfield","Missouri","65802","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-93.29824,37.21533,{"lat":48,"lon":47},{"facility":51,"status":35,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":35},"Icon \u002FId# 257524","San Antonio","Texas","78209",{"type":45,"coordinates":56},[57,58],-98.49363,29.42412,{"lat":58,"lon":57},{"facility":61,"status":35,"city":62,"state":63,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":35},"Icon \u002FId# 257525","Salt Lake City","Utah","84124",{"type":45,"coordinates":66},[67,68],-111.89105,40.76078,{"lat":68,"lon":67},{"type":71,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100507851","phase-1-study-to-assess-adverse-events-and-compare-how-oral-ubrogepant-and-oral-atogepant-moves-through-the-body-of-healthy-female-adult-volunteers-100507851",false,"NCT05892757","Study to Assess Adverse Events and Compare How Oral Ubrogepant and Oral Atogepant Moves Through the Body of Healthy Female Adult Volunteers","A Phase 1 Lactation Study in Healthy Adult Lactating Female Subjects One to Six Months Post-Partum to Evaluate the Pharmacokinetics and Safety of Ubrogepant and Atogepant","Inclusion Criteria:\n\n* Healthy, lactating, female volunteers who delivered one or more normal-term infants and established lactation from 1 - 6 months post-partum at the time of enrollment.\n* Had a normal pregnancy (gestation of 37-42 weeks) with no clinically significant complications.\n* Willing to permit the use of pasteurized donor milk, infant formula, or previously pumped\u002Fstored human milk to feed the infant.\n* Agree to the use of provided breast pumps for the pumping of breast milk during the milk collection regimen of the study.\n\nExclusion Criteria:\n\n\\- Prior exposure to ubrogepant or atogepant within the past 30 days.","FEMALE","18 Years","45 Years",{"count":83,"type":84},24,"ACTUAL","INTERVENTIONAL",[87],"PHASE1","This study will assess adverse events and compare how ubrogepant and atogepant tablets move through the body of healthy adult lactating female participants.\n\nUbrogepant and atogepant are approved drugs for treatment of migraine in adults. Participants will be assigned to one of the 2 treatment arms to receive atogepant or ubrogepant. Approximately 24 healthy adult lactating female participants will be enrolled at 3 sites in the United States\n\nParticipants will receive oral tablets of ubrogepant or atogepant on Day 1 and will be followed for 30 days.",[90],"Healthy Volunteers",[90,9,15],"COMPLETED","2024-03-11",{"date":95,"type":84},"2024-03-12",{"date":97,"type":84},"2023-07-11",{"date":99,"type":84},"2024-02-22",{"name":5,"class":6},3]