[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431831":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":33,"responsibleParty":55,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Children's Mercy Hospital Kansas City","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":11},"Baseline Mevalonate and MRI Imaging","NO_INTERVENTION",null,{"label":13,"type":14,"description":11,"interventionNames":15},"Mevalonate Change After Rosuvastatin","EXPERIMENTAL",[16],"Drug: Rosuvastatin 10mg",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Rosuvastatin 10mg","Rosuvastatin will be administered to all participants on Study Day #2",[13],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Jonathan Wagner, DO","CONTACT","816-731-7240","jbwagner@cmh.edu",{"name":30,"role":26,"phone":31,"phoneExt":11,"email":32},"Jazzie K Holliday","816-302-3500","jkholliday@cmh.edu",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Children's Mercy Hospital","RECRUITING","Kansas City","Missouri","64108","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-94.57857,39.09973,{"lat":46,"lon":45},[49,53],{"name":50,"role":26,"phone":51,"phoneExt":52,"email":28},"Jonathan B Wagner, DO","816-234-3000","59373",{"name":50,"role":54,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Jon Wagner","Principal Investigator","100431831","phase-1-liver-adiposity-effects-on-pediatric-statin-100431831",false,"NCT04903223","Liver Adiposity Effects on Pediatric Statin","Effects of Pediatric Liver Adiposity on Statin Disposition and Response","Inclusion Criteria:\n\n* 8-21 years\n* LDL cholesterol \\>130mg\u002Fdl (\\>95% percentile)\n* SLCO1B1 c.521TT genotype\n* Provide informed permission-assent(\\\u003C18 yrs.) or consent (≥18 yrs.)\n* Fasting overnight (\\~8 hrs.)\n* Enrolled in Cardiology Pharmacogenomic Repository\n\nExclusion Criteria:\n\n* Pregnancy\n* Non-fasting\n* Non-removable metal in body or MRI unsafe\n* Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the study.\n* Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.\n* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\\* (absorption, metabolism, distribution, or clearance)\n* Pharmacotherapy that interacts with statins (OATP1B1 inducers\u002Finhibitors) \\*\n* Inability to swallow a tablet\n* \\>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin\n* Diarrhea in the last 24 hours\n* Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)",true,"ALL","8 Years","21 Years",{"count":70,"type":71},50,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin",[77],"Cholesterol; Lipidosis","2026-06-23",{"date":80,"type":81},"2026-06-25","ACTUAL",{"date":83,"type":81},"2021-04-01",{"date":85,"type":71},"2027-03-31",{"name":5,"class":6},1]