[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07626281":3,"trial-entities:NCT07626281":130,"trial-summary:NCT07626281":134},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":48,"secondary_outcomes":74,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":82,"eligibility_criteria":83,"std_ages":91,"locations":93,"central_contacts":119,"overall_officials":125,"references":128,"see_also_links":129},"NCT07626281","CKJX839A12107","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","RECRUITING","2026-12-21","2026-07","2026-07-10","2026-06-09","Novartis Pharmaceuticals","INDUSTRY",false,"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.","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.",[19],"Inclisiran Formulation",[21,22,23,24,25,26],"Inclisiran containing polysorbate 80","healthy male and female participants","safety","tolerability","pharmacokinetics","pharmacodynamics","INTERVENTIONAL","TREATMENT",[30],"PHASE1",{"count":32,"type":33},120,"ESTIMATED",[35,43],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"DRUG","Inclisiran formulation containing PS80","Inclisiran 284 mg",[40],"Arm B (inclisiran - formulation containing PS80)",[42],"KJX839",{"type":36,"name":44,"description":38,"armGroupLabels":45,"otherNames":47},"Currently marketed inclisiran formulation",[46],"Arm A (inclisiran - currently marketed formulation)",[42],[49,53,56,59,62,65,68,71],{"measure":50,"description":51,"timeFrame":52},"Primary plasma PK parameters: Cmax","Cmax = maximum observed plasma concentration","Day 1, Day 2, Day 3 and Day 4",{"measure":54,"description":55,"timeFrame":52},"Primary plasma PK parameters: AUClast","AUClast = AUC from time zero to the last measurable concentration sampling time",{"measure":57,"description":58,"timeFrame":52},"Primary plasma PK parameters: AUCinf","AUCinf = AUC from time zero to infinity",{"measure":60,"description":61,"timeFrame":52},"Additional PK parameters: AUC0-24hr","AUC0-24hr = AUC from time zero to 24 hours",{"measure":63,"description":64,"timeFrame":52},"Additional PK parameters: Tmax","Tmax = time to reach maximum plasma concentration",{"measure":66,"description":67,"timeFrame":52},"Additional PK parameters: T1\u002F2","T1\u002F2 = elimination half-life",{"measure":69,"description":70,"timeFrame":52},"Additional PK parameters: CL\u002FF","CL\u002FF = total body clearance",{"measure":72,"description":73,"timeFrame":52},"Additional PK parameters: Vz\u002FF","Vz\u002FF = apparent volume of distribution",[75],{"measure":76,"description":77,"timeFrame":78},"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","ALL","18 Years","60 Years",true,{"inclusion":84,"exclusion":87,"raw_text":90},[85,86],"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.","Body mass index (BMI) between 18 and 35 kg\u002Fm2, inclusive, at screening with a body weight of at least 50 kg.",[88,89],"Participants with homozygous and heterozygous familial hypercholesterolemia will be excluded.","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.","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",[92],"ADULT",[94,103,111],{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":99,"geoPoint":100},"Lenexa Research Unit","Lenexa","Kansas","66219","United States",{"lat":101,"lon":102},38.95362,-94.73357,{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":99,"geoPoint":108},"Cardiovasular Renal Metabolism","San Antonio","Texas","78232",{"lat":109,"lon":110},29.42412,-98.49363,{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":99,"geoPoint":116},"Salt Lake City Research Unit","Salt Lake City","Utah","84124",{"lat":117,"lon":118},40.76078,-111.89105,[120,124],{"name":13,"role":121,"phone":122,"email":123},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":13,"role":121},[126],{"name":13,"affiliation":13,"role":127},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":131,"biomarkers":133},[132],"Healthy Volunteers",[],{"nct_id":4,"found":82,"summary":135,"prompt_version":145},{"design":136,"status":137,"heading":138,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This is an open-label study, meaning you and the study team will know which inclisiran formulation you receive. It will involve about 152 healthy adult participants with elevated LDL-C.","completed","Inclisiran Formulations Study","This study is looking at two different versions of inclisiran, a medication used to lower cholesterol. One is the inclisiran you can get now, and the other is a new version that includes polysorbate 80 (PS80). Researchers want to see if the new version is safe, how well your body handles it, and how it moves through your system compared to the current inclisiran. You might be able to join if you are a healthy male or a female who cannot get pregnant, between 18 and 60 years old, with slightly high LDL-C (bad cholesterol) and normal triglycerides, and not currently taking cholesterol-lowering medicines. The study will measure how much inclisiran is in your blood at different times to understand how it works. The study status is currently unclear.","Your blood will be tested to measure inclisiran levels on Day 1, Day 2, Day 3, and Day 4 after the injection.",129,"You will receive a single injection of either inclisiran formulation under your skin. Your total participation in the study will last about 118 days, including screening, a baseline period, and a 90-day treatment period.","Not stated in the trial record.",[],"v2"]