This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.
The purpose of this research study is to see how the body breaks down certain medicines. Many medicines are broken down in the liver. The liver is an organ in the belly. A person's age, size, genetics (DNA), and the health of their liver decide how quickly the body breaks down medicines and how much medication a person needs to take. Everybody's liver has some fat in it, but the amount of fat is different from person to person. The purpose of this study is to see if the amount of fat in the liver affects how quickly acid suppression medications start and stop working and get removed from the body.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.
Children's Mercy Kansas City
Kansas City, Missouri, United States
Plasma 1/2 Life (t1/2)
plasma elimination 1/2 life (t1/2)
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Weight-adjusted Clearance
Weight-adjusted Drug plasma clearance (CL/F)
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
AUC
Plasma Area Under the Curve
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Hepatic Fat Fraction
Hepatic Fat Fraction as measured by liver Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Time frame: MRI obtained anytime within 30 days of PK visit
Tmax
Time to max plasma concentration
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Cmax
Weight-Adjusted maximum plasma concentration
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Inflammatory Cytokines
Mean and standard deviation of inflammatory cytokine levels measured from 58 of 71 participants who received pantoprazole. Cytokines include: INF-γ, IL-1β, IL-6.
Time frame: Cytokines obtained from blood samples collected at pantoprazole PK study visit.
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