[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479999":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":49,"centralContacts":39,"locations":53,"responsibleParty":97,"collaborators":39,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":39,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":122,"whyStopped":39,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,16,20,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"ABBV-576 with Galicaftor + Navocaftor","EXPERIMENTAL","Participants will receive ABBV-576 for 14 consecutive days, with navocaftor + galicaftor for the latter 7 consecutive days.",[13,14,15],"Drug: Galicaftor","Drug: ABBV-576","Drug: Navocaftor",{"label":17,"type":10,"description":18,"interventionNames":19},"Navocaftor + Galicaftor with ABBV 576","Participants will receive Navocaftor + galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Optional: Navocaftor with ABBV 576","Participants will receive Navocaftor for 14 consecutive days with ABBV 576 for the latter 7 consecutive days.",[14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Optional: Galicaftor with ABBV 576","Participants will receive Galicaftor for 14 consecutive days, with ABBV 576 for the latter 7 consecutive days.",[13,14],{"label":29,"type":10,"description":30,"interventionNames":31},"Optional: Midazolam with ABBV-576 + Navocaftor","Participants will receive Midazolam alone and in combination with multiple doses of ABBV-576 + navocaftor.",[14,15,32],"Drug: Midazolam",[34,40,43,46],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Galicaftor","Oral",[9,17,25],null,{"type":35,"name":41,"description":37,"armGroupLabels":42,"otherNames":39},"ABBV-576",[9,17,25,29,21],{"type":35,"name":44,"description":37,"armGroupLabels":45,"otherNames":39},"Navocaftor",[9,17,29,21],{"type":35,"name":47,"description":37,"armGroupLabels":48,"otherNames":39},"Midazolam",[29],[50],{"name":51,"affiliation":5,"role":52},"ABBVIE INC.","STUDY_DIRECTOR",[54,67,77,87],{"facility":55,"status":39,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":39},"Anaheim Clinical Trials LLC \u002FID# 248824","Anaheim","California","92801-2658","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-117.9145,33.83529,{"lat":65,"lon":64},{"facility":68,"status":39,"city":69,"state":70,"zip":71,"country":59,"countryCode":60,"cosmosGeoPoint":72,"geoPoint":76,"contacts":39},"Clinical Pharmacology of Miami \u002FID# 248823","Miami","Florida","33014",{"type":62,"coordinates":73},[74,75],-80.19366,25.77427,{"lat":75,"lon":74},{"facility":78,"status":39,"city":79,"state":80,"zip":81,"country":59,"countryCode":60,"cosmosGeoPoint":82,"geoPoint":86,"contacts":39},"PPD Clinical Research Unit -Las Vegas \u002FID# 248853","Las Vegas","Nevada","89113-2235",{"type":62,"coordinates":83},[84,85],-115.13722,36.17497,{"lat":85,"lon":84},{"facility":88,"status":39,"city":89,"state":90,"zip":91,"country":59,"countryCode":60,"cosmosGeoPoint":92,"geoPoint":96,"contacts":39},"PPD Clinical Research Unit - Austin \u002FID# 248854","Austin","Texas","78744",{"type":62,"coordinates":93},[94,95],-97.74306,30.26715,{"lat":95,"lon":94},{"type":98,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100479999","phase-1-a-study-to-assess-the-pharmacokinetics-and-safety-of-co-administered-oral-galicaftor-navocaftor-and-abbv-576-in-healthy-adults-for-the-treatment-of-cystic-fibrosis-100479999",false,"NCT05530278","A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis","Assessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy Volunteers","ABBV-576 DDI","Inclusion Criteria:\n\n* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg\u002Fm2 after rounding to the tenths decimal.\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* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* History of any clinically significant sensitivity or allergy to any medication or food.\n* History of any clinically significant condition listed in the protocol.",true,"FEMALE","18 Years","65 Years",{"count":112,"type":113},24,"ACTUAL","INTERVENTIONAL",[116],"PHASE1","Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor\u002Fnavocaftor\u002FABBV-576.",[119],"Healthy Volunteers",[36,44,41,121],"Cystic Fibrosis","COMPLETED","2023-02-16",{"date":125,"type":113},"2023-02-21",{"date":127,"type":113},"2022-09-20",{"date":129,"type":113},"2022-11-29",{"name":5,"class":6},4]