[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642379":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":48,"locations":54,"responsibleParty":69,"collaborators":35,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":35,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":35,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":57,"whyStopped":35,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment A","EXPERIMENTAL","Each participant will receive single dose treatment of laroprovstat\u002Fezetimibe FCDP test formulation in a fasted state.",[13],"Drug: Laroprovstat\u002Fezetimibe FCDP",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment B","Each participant will receive single dose treatment of laroprovstat plus ezetimibe single therapy product (STP) reference formulations in a fasted state.",[18,19],"Drug: Laroprovstat STP","Drug: Ezetimibe STP",{"label":21,"type":10,"description":22,"interventionNames":23},"Treatment C","Each participant will receive single dose treatment of laroprovstat\u002Fezetimibe FCDP test formulation in a fed state.",[13],{"label":25,"type":10,"description":26,"interventionNames":27},"Treatment D","Each participant will receive single dose treatment of laroprovstat\u002Fezetimibe FCDP test formulation (slow variant) in a fasted state.",[28],"Drug: Laroprovstat\u002Fezetimibe FCDP-slow variant",[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Laroprovstat\u002Fezetimibe FCDP","Laroprovstat\u002Fezetimibe will be administered orally.",[9,21],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Laroprovstat STP","Laroprovstat will be administered orally.",[15],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Ezetimibe STP","Ezetimibe will be administered orally.",[15],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Laroprovstat\u002Fezetimibe FCDP-slow variant","Laroprovstat\u002Fezetimibe slow variant will be administered orally",[25],[49],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":35},"Research Site","RECRUITING","Brooklyn","Maryland","21225","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-76.60219,39.23039,{"lat":67,"lon":66},{"type":70,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100642379","phase-1-a-phase-i-cross-over-study-comparing-the-relative-bioavailability-of-laroprovstat-plus-ezetimibe-fixed-combination-drug-products-versus-their-single-therapy-products-in-healthy-adults-100642379",false,"NCT07622433","A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults","A Phase I, Randomized, Open-label, 4-period, 4-treatment, Single-dose, Cross-over Study to Assess the Relative Bioavailability of Laroprovstat\u002FEzetimibe Fixed Combination Drug Products to the Single Therapy Products in Healthy Adults","Inclusion Criteria:\n\n* Healthy male and female participants aged 18 to 55 years at the time of signing consent.\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the study site.\n* Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.\n* Have a Body mass index (BMI) between 18 and 30 kg\u002Fm2 inclusive and weigh at least 50 kg.\n\nExclusion Criteria:\n\n* History of any clinically important disease or disorder.\n* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* History of severe allergy\u002Fhypersensitivity or ongoing clinically important allergy\u002Fhypersensitivity to drugs with a similar chemical structure or class to laroprovstat or ezetimibe.\n* Treatment with any lipid lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.\n* Treatment with drugs for reduction or inhibition of Proprotein convertase subtilisin\u002Fkexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit or inclisiran at any time.",true,"ALL","18 Years","55 Years",{"count":83,"type":84},18,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.",[90],"Healthy Participants",[92,93,94,95,96,97,98,99,100],"Fixed Combination Drug Products","Bioavailability","Pharmacokinetics","Cross-over study","Hyperlipidemia","Dyslipidemia","Relative bioavailability","Food effect","Oral Formulations","2026-06-15",{"date":103,"type":104},"2026-06-16","ACTUAL",{"date":106,"type":104},"2026-06-10",{"date":108,"type":84},"2026-09-07",{"name":5,"class":6},1]