RecruitingPhase 1NCT04903223
Liver Adiposity Effects on Pediatric Statin
Effects of Pediatric Liver Adiposity on Statin Disposition and Response
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
50 participants
Start Date
Apr 1, 2021
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 8 YearsMax Age: 21 Years
Inclusion Criteria6
- -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 Criteria11
- Pregnancy
- Non-fasting
- Non-removable metal in body or MRI unsafe
- 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.
- Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual 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 interacts with statins (OATP1B1 inducers/inhibitors) *
- Inability to swallow a tablet
- >5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin
- Diarrhea in the last 24 hours
- Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)
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Interventions
DRUGRosuvastatin 10mg
Rosuvastatin will be administered to all participants on Study Day #2
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04903223