[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454311":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":51,"centralContacts":42,"locations":55,"responsibleParty":69,"collaborators":42,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":42,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":42,"enrollmentInfo":81,"targetDuration":42,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":97,"whyStopped":42,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,16,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1","EXPERIMENTAL","Participants will receive a single oral dose of alpelisib film-coated tablet at 50 mg in fed state (treatment A) in period 1 followed by a single oral dose of alpelisib granule at 50 mg in fed state (treatment B) in period 2 and a single oral dose of alpelisib granule at 50 mg in fasted state (treatment C) in period 3.",[13,14,15],"Drug: Treatment A","Drug: Treatment B","Drug: Treatment C",{"label":17,"type":10,"description":18,"interventionNames":19},"Sequence 2","Participants will receive a single oral dose of alpelisib granule at 50 mg in fed state (treatment B) in period 1 followed by a single oral dose of alpelisib granule at 50 mg in fasted state (treatment C) in period 2 followed by a single oral dose of alpelisib film-coated tablet at 50 mg in fed state (treatment A) in period 3.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Sequence 3","Participants will receive a single oral dose of alpelisib granule at 50 mg in fasted state (treatment C) in period 1 followed by a single oral dose of alpelisib film-coated tablet at 50 mg in fed state (treatment A) in period 2 followed by a single oral dose of alpelisib granule at 50 mg in fed state (treatment B) in period 3.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Sequence 4","Participants will receive a single oral dose of alpelisib granule at 50 mg in fasted state (treatment C) in period 1 followed by a single oral dose of alpelisib granule at 50 mg in fed state (treatment B) in period 2 followed by a single oral dose of alpelisib film-coated tablet at 50 mg in fed state (treatment A).",[13,14,15],{"label":29,"type":10,"description":30,"interventionNames":31},"Sequence 5","Participants will receive a single oral dose of alpelisib film-coated tablet at 50 mg in fed state (treatment A) in period 1 followed by a single oral dose of alpelisib granule at 50 mg in fasted state (treatment C) in period 2 followed by a single oral dose of alpelisib granule at 50 mg in fed state (treatment B).",[13,14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"Sequence 6","Participants will receive a single oral dose of alpelisib granule at 50 mg in fed state (treatment B) in period 1 followed by a single oral dose of alpelisib film-coated tablet at 50 mg in fed state (treatment A) in period 2 followed by a single oral dose of alpelisib granule at 50 mg in fasted state (treatment C).",[13,14,15],[37,43,47],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Treatment A","Single oral dose of alpelisib film-coated tablet at 50 mg in fed state",[9,17,21,25,29,33],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Treatment B","Single oral dose of alpelisib granule at 50 mg in fed state",[9,17,21,25,29,33],{"type":38,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Treatment C","Single oral dose of alpelisib granule at 50 mg in fasted state",[9,17,21,25,29,33],[52],{"name":53,"affiliation":53,"role":54},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[56],{"facility":57,"status":42,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":42},"Novartis Investigative Site","Belfast","Northern Ireland","BT9 6AD","United Kingdom","UK",{"type":64,"coordinates":65},"Point",[66,67],-5.92541,54.59682,{"lat":67,"lon":66},{"type":70,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100454311","phase-1-investigate-bioequivalence-of-alpelisib-granule-and-film-coated-tablet-formulation-and-the-food-effect-of-alpelisib-granule-formulation-in-adult-healthy-volunteers-100454311",false,"NCT05195892","Investigate Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers","A Single-center, Randomized, Open-label, Three-period Crossover Study to Investigate the Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation, and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers","Inclusion Criteria:\n\n* Male or female participants 18 and 55 years of age\n* Female participants must be postmenopausal or not of child bearing potential.\n* Participants must weigh 50 kg - 120 kg and have BMI= 18.0-30.0 kg\u002Fm2\n* Participants should be in good health as determined by no clinically significant findings from the medical history, physical examination, vital signs, and ECG.\n* Participant must have laboratory values (including fasting plasma glucose and HgbA1C) within the reference range at the local laboratory\n* At screening, and at baseline visit of each Period, participant has vital signs which are within the protocol defined ranges\n\nExclusion Criteria:\n\n* Women of childbearing potential\n* Sexually active male participant with partner(s) of women of childbearing potential, UNLESS agree to comply with highly effective contraception AND use a condom\n* Participant with\n* significant illness, including infections, or hospitalization within the 30 days prior to dosing.\n* diabetes mellitus or participants with fasting plasma glucose (FPG) levels \\> 100 mg\u002FdL or \\>5.55 mmol\u002FL.\n* clinically significant risk of developing diabetes mellitus during the study\n* Use of:\n* tobacco products within 3 months prior to first dosing\n* drug or alcohol abuse within 12 months prior to first dose\n* alcohol within 48 hours prior to the dosing of each treatment period.\n* any prescription or non-prescription, herbal medication, dietary supplements or vitamins during 14 days prior to dosing..\n* History of :\n* clinically significant hematologic, renal, endocrinologic, pulmonary, cardiovascular, hepatic, or allergic disease, medically documented. including uncontrolled hypertension, interstitial lung disease, or other causes of dyspnea, acute pancreatitis within 1 year of screening or past medical\n* chronic pancreatitis.\n* cardiac disease\n* immunodeficiency diseases\n* malignancy of any organ system carcinoma of the skin or in situ cervical cancer), within 5 years,\n* erythema multiform (EM), Steven-Johnson-Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN).\n* history or presence of\n* any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs.\n* clinically significant ECG abnormalities or a family prolonged QT-interval syndrome.\n* chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).\n\nOther inclusion\u002Fexclusion criteria may apply",true,"ALL","18 Years",{"count":82,"type":83},33,"ACTUAL","INTERVENTIONAL",[86],"PHASE1","The purpose of this study is to assess bioequivalence of the granule formulation of alpelisib as compared to the film-coated tablet formulation in healthy volunteers in the fed state. In addition, the food effect of the granule formulation will be investigated between the fed state and the fasted state.",[89],"Healthy Volunteers",[91,92,93,94,95,96],"adult","bioequivalence","food effect","three-period six sequence crossover","alpelisib","BYL719","COMPLETED","2022-12-27",{"date":100,"type":83},"2022-12-28",{"date":102,"type":83},"2022-02-03",{"date":104,"type":83},"2022-11-09",{"name":53,"class":6},1]