Liver Adiposity Effects on Pediatric Statin

Children's Mercy Hospital Kansas City

Status and phase

Enrolling

Phase 1

Conditions

Cholesterol; Lipidosis

Treatments

Drug: Rosuvastatin 10mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04903223

STUDY00001550

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

8 to 21 years old

Volunteers

Accepts Healthy Volunteers

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 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.)