[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640209":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":39,"armGroups":47,"interventions":59,"overallOfficials":71,"centralContacts":75,"locations":81,"responsibleParty":142,"collaborators":39,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":39,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":39,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":84,"whyStopped":39,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":39},[9,13,16,19,22,25,28,31],{"measure":10,"description":11,"timeFrame":12},"Primary plasma PK parameters: Cmax","Cmax = maximum observed plasma concentration","Day 1, Day 2, Day 3 and Day 4",{"measure":14,"description":15,"timeFrame":12},"Primary plasma PK parameters: AUClast","AUClast = AUC from time zero to the last measurable concentration sampling time",{"measure":17,"description":18,"timeFrame":12},"Primary plasma PK parameters: AUCinf","AUCinf = AUC from time zero to infinity",{"measure":20,"description":21,"timeFrame":12},"Additional PK parameters: AUC0-24hr","AUC0-24hr = AUC from time zero to 24 hours",{"measure":23,"description":24,"timeFrame":12},"Additional PK parameters: Tmax","Tmax = time to reach maximum plasma concentration",{"measure":26,"description":27,"timeFrame":12},"Additional PK parameters: T1\u002F2","T1\u002F2 = elimination half-life",{"measure":29,"description":30,"timeFrame":12},"Additional PK parameters: CL\u002FF","CL\u002FF = total body clearance",{"measure":32,"description":33,"timeFrame":12},"Additional PK parameters: Vz\u002FF","Vz\u002FF = apparent volume of distribution",[35],{"measure":36,"description":37,"timeFrame":38},"Number of participants with AEs","Number of participants with AEs, including abnormal vital signs, ECGs, injection site reactions and safety laboratory parameters.","Up to Day 90",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE","This is a randomized, single-dose, open-label, parallel-group, study to evaluate the PK, safety, and tolerability of inclisiran 284 mg. The study drug will be administered as a single SC injection to the abdomen administered as 2 different formulations (the marketed formulation and a test formulation containing PS80). Approximately 152 adult participants (76 per formulation) with elevated serum LDL-C, but otherwise healthy, are planned to be enrolled.\n\nThe duration of the study for each participant will be approximately 118 days including the screening, up to 28 days, baseline period, and treatment period of 90 days.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Arm A (inclisiran - currently marketed formulation)","ACTIVE_COMPARATOR","Inclisiran 284 mg × 1 single dose on Day 1",[53],"Drug: Currently marketed inclisiran formulation",{"label":55,"type":56,"description":51,"interventionNames":57},"Arm B (inclisiran - formulation containing PS80)","EXPERIMENTAL",[58],"Drug: Inclisiran formulation containing PS80",[60,67],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Inclisiran formulation containing PS80","Inclisiran 284 mg",[55],[66],"KJX839",{"type":61,"name":68,"description":63,"armGroupLabels":69,"otherNames":70},"Currently marketed inclisiran formulation",[49],[66],[72],{"name":73,"affiliation":73,"role":74},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[76,80],{"name":73,"role":77,"phone":78,"phoneExt":39,"email":79},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":73,"role":77,"phone":39,"phoneExt":39,"email":39},[82,100,105,118,124,137],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"ICON Early Clin Services Lenexa","RECRUITING","Lenexa","Kansas","66219","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-94.73357,38.95362,{"lat":94,"lon":93},[97],{"name":98,"role":99,"phone":39,"phoneExt":39,"email":39},"Patrick Yao","PRINCIPAL_INVESTIGATOR",{"facility":101,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":102,"geoPoint":104,"contacts":39},"Lenexa Research Unit",{"type":91,"coordinates":103},[93,94],{"lat":94,"lon":93},{"facility":106,"status":84,"city":107,"state":108,"zip":109,"country":88,"countryCode":89,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"ICON Early Clin Service San Antonio","San Antonio","Texas","78209",{"type":91,"coordinates":111},[112,113],-98.49363,29.42412,{"lat":113,"lon":112},[116],{"name":117,"role":99,"phone":39,"phoneExt":39,"email":39},"Chinonye Ogbonnaya-Odor",{"facility":119,"status":84,"city":107,"state":108,"zip":120,"country":88,"countryCode":89,"cosmosGeoPoint":121,"geoPoint":123,"contacts":39},"Cardiovasular Renal Metabolism","78232",{"type":91,"coordinates":122},[112,113],{"lat":113,"lon":112},{"facility":125,"status":84,"city":126,"state":127,"zip":128,"country":88,"countryCode":89,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"ICON Early Clinical Services SLC","Salt Lake City","Utah","84124",{"type":91,"coordinates":130},[131,132],-111.89105,40.76078,{"lat":132,"lon":131},[135],{"name":136,"role":99,"phone":39,"phoneExt":39,"email":39},"Julia Garcia",{"facility":138,"status":84,"city":126,"state":127,"zip":128,"country":88,"countryCode":89,"cosmosGeoPoint":139,"geoPoint":141,"contacts":39},"Salt Lake City Research Unit",{"type":91,"coordinates":140},[131,132],{"lat":132,"lon":131},{"type":143,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100640209","phase-1-assessment-of-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-a-new-formulation-of-inclisiran-containing-polysorbate-80-compared-to-the-currently-marketed-formulation-100640209",false,"NCT07626281","Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation","A Randomized, Open-label, Single-dose, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inclisiran Containing Polysorbate 80 Versus Inclisiran Alone in Participants With Elevated Low-density Lipoprotein Cholesterol","Inclusion Criteria:\n\n* Healthy male and female (non-childbearing potential) participants between 18 and 60 years of age (inclusive) with fasting serum LDL-C between 100 and 189 mg\u002FdL (2.6 to 4.89 mmol\u002FL) and fasting triglyceride \\\u003C400 mg\u002FdL (\\\u003C4.52 mmol\u002FL) that are not on statin or any other lipid lowering therapy.\n* Body mass index (BMI) between 18 and 35 kg\u002Fm2, inclusive, at screening with a body weight of at least 50 kg.\n\nExclusion Criteria:\n\n* Participants with homozygous and heterozygous familial hypercholesterolemia will be excluded.\n* Historical or current use of any statin (i.e. study participants must be statin naive), other oral LDL-C-lowering medication or supplements that in investigators' judgment may affect serum LDL-C levels.\n\nOther protocol inclusion\u002Fexclusion criteria may apply",true,"ALL","18 Years","60 Years",{"count":156,"type":157},152,"ESTIMATED","INTERVENTIONAL",[160],"PHASE1","The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a single 284 mg subcutaneous (SC) administration.",[163],"Inclisiran Formulation",[165,166,167,168,169,170],"Inclisiran containing polysorbate 80","healthy male and female participants","safety","tolerability","pharmacokinetics","pharmacodynamics","2026-10-01",{"date":173,"type":174},"2026-10-05","ACTUAL",{"date":176,"type":174},"2026-06-09",{"date":178,"type":157},"2026-12-21",{"name":73,"class":6},6]