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Completed

NCT Number: NCT02186652

PK Study With Pantoprazole in Obese Children and Adolescents

Multicenter, comparative single-dose pharmacokinetic (PK) study

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Key information

Conditions

Gastroesophageal Reflux Disease Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arkansas, Little Rock, Arkansas, United States

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About this study

Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Symptomatic asthma
  • 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.

Treatment and study plan

Pantoprazole

Drug

Primary outcomes

  1. Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).

    Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 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. Here we report Cmax.

  2. Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).

    Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 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. Here we report Tmax.

  3. PK Sampling

    Time frame: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing

    Total number of fresh plasma samples (all participants)

  4. Drug Concentration in Plasma Samples

    Time frame: Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing

    Concentration of panto in plasma and concentration of panto sulfone in plasma

  5. Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).

    Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 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. Here we report AUC TBW.

  6. Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).

    Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 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. Here we report AUC LBW.

  7. Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).

    Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 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. Here we report CL/F TBW.

  8. Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).

    Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 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. Here we report Vd/F TBW.

  9. Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).

    Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 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. Here we report Vd/F LBW.

Secondary outcomes

  1. The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype

    Time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose

    To examine the association of CYP2C19 genotype and its association with CYP2C19 phenotypes. To characterize the ability of the CYP2C19 genotype to predict pantoprazole plasma clearance, a correlation with CYP2C19 phenotype was explored using both standard linear and nonlinear regression techniques and their respective tests for significance and goodness of fit. In addition, the impact of all covariates on pantoprazole systemic exposure and apparent plasma clearance (e.g., demographic determinants of extent of obesity such as the waist:hip ratio, CYP2C19 genotype, BMI, and REE) was explored using validated population-based PK methods (NONMEM).

Sponsors and collaborators

Lead sponsor

Phillip Brian Smith

Other

Collaborators

  • The Emmes Company, LLC

Registry information

Official study title

The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents

Acronym: PAN01

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2014
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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