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Trial record 1 of 1 for:    NCT02186652
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PK Study With Pantoprazole in Obese Children and Adolescents (PAN01)

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ClinicalTrials.gov Identifier: NCT02186652
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : August 5, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University

Brief Summary:
Multicenter, comparative single-dose pharmacokinetic (PK) study

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Pantoprazole Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents
Actual Study Start Date : June 4, 2014
Actual Primary Completion Date : September 13, 2015
Actual Study Completion Date : September 13, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pantoprazole Drug: Pantoprazole



Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant is between 6 and 17 (inclusive) years of age at the time of consent
  2. BMI ≥95th percentile
  3. Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:

    1. clinical symptoms consistent with GERD as determined by the investigator
    2. a diagnosis of erosive esophagitis by endoscopy
    3. esophageal biopsy with histopathology consistent with reflux esophagitis
    4. abnormal pH-metry consistent with reflux esophagitis
    5. other test result consistent with GERD
  4. 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:

  1. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48 hours prior to dose of study drug
  2. 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
  3. Consumption of food after midnight on the day of the baseline visit
  4. Symptomatic asthma
  5. Type I diabetes
  6. History of adverse reaction to PPI
  7. 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
  8. Serum creatinine ≥2.0 mg/dL
  9. For females of childbearing potential, a positive pregnancy test result
  10. Known infection with hepatitis B, C, or HIV
  11. Any other condition that, in the opinion of the principal investigator, makes participation unadvised or unsafe.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186652


Locations
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United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72202
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
Phillip Brian Smith
The Emmes Company, LLC
Investigators
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Principal Investigator: Phillip B Smith, MD Duke Clinical Research Institute
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Phillip Brian Smith, Principal Investigator, Duke University
ClinicalTrials.gov Identifier: NCT02186652    
Other Study ID Numbers: Pro00048765
First Posted: July 10, 2014    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: September 17, 2019
Last Verified: September 2019
Keywords provided by Phillip Brian Smith, Duke University:
obese
children
adolescents
GERD
pharmacokinetic
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action