PK Study With Pantoprazole in Obese Children and Adolescents (PAN01)
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ClinicalTrials.gov Identifier: NCT02186652
: July 10, 2014
Last Update Posted
: June 22, 2017
Phillip Brian Smith
The EMMES Corporation
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
Pharmacokinetic Analysis in obese children after one single oral dose of Pantoprazole. The PK parameters for pantoprazole will be measured from Cmax, Tmax, Ka, Kel, AUC, VDss/F & CL/F [ Time Frame: up to 12 hours ]
The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing.
Secondary Outcome Measures
The CYP2C19 genotype and its association with CYP2C19 phenotype (PK) will be measured with the analysis of a blood sample [ Time Frame: 12 hours ]
At screening a 1.0 ml venous blood sample will be placed into a tube for CYP2C19 genotyping. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing to better characterize the drug disposition profile in those with two non-functional alleles.
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Ages Eligible for Study:
6 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participant is between 6 and 17 (inclusive) years of age at the time of consent
BMI ≥95th percentile
Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
clinical symptoms consistent with GERD as determined by the investigator
a diagnosis of erosive esophagitis by endoscopy
esophageal biopsy with histopathology consistent with reflux esophagitis
abnormal pH-metry consistent with reflux esophagitis
other test result consistent with GERD
Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements
Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate, valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within seven days prior to dose of study drug
Consumption of food after midnight on the day of the baseline visit
Type I diabetes
History of adverse reaction to PPI
Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150 IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L
Serum creatinine ≥2.0 mg/dL
For females of childbearing potential, a positive pregnancy test result
Known infection with hepatitis B, C, or HIV
Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.