Liver Adiposity Effects on Pediatric Statin

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Children's Mercy Hospital Kansas City
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 8-21 years

• LDL cholesterol >130mg/dl (>95% percentile)

• SLCO1B1 c.521TT genotype

• Provide informed permission-assent(<18 yrs.) or consent (≥18 yrs.)

• Fasting overnight (~8 hrs.)

• Enrolled in Cardiology Pharmacogenomic Repository

Exclusion Criteria:

• Pregnancy

• Non-fasting

• Non-removable metal in body or MRI unsafe

• Currently on or history of statin therapy

• Underlying congenital or acquired hemodynamically CV disease

• History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition * (absorption, metabolism, distribution, or clearance)

• Pharmacotherapy that interact with statins (OATP1B1 inducers/inhibitors) *

• Inability to swallow a tablet

•>3x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin

• Diarrhea in the last 24 hours