<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02186652</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00048765</org_study_id>
    <nct_id>NCT02186652</nct_id>
  </id_info>
  <brief_title>PK Study With Pantoprazole in Obese Children and Adolescents</brief_title>
  <acronym>PAN01</acronym>
  <official_title>The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Phillip Brian Smith</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Emmes Company, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter, comparative single-dose pharmacokinetic (PK) study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with&#xD;
      gastroesophageal reflux disease (GERD) following administration of an oral dose of&#xD;
      pantoprazole.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2014</start_date>
  <completion_date type="Actual">September 13, 2015</completion_date>
  <primary_completion_date type="Actual">September 13, 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
    <description>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, &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
    <description>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, &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK Sampling</measure>
    <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</time_frame>
    <description>Total number of fresh plasma samples (all participants)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug Concentration in Plasma Samples</measure>
    <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</time_frame>
    <description>Concentration of panto in plasma and concentration of panto sulfone in plasma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
    <description>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, &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
    <description>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, &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
    <description>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, &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
    <description>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, &amp; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
    <description>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, &amp; 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype</measure>
    <time_frame>0, 1, 2, 3, 4, 6, 8, 12 hours post-dose</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Pantoprazole</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole</intervention_name>
    <arm_group_label>Pantoprazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant is between 6 and 17 (inclusive) years of age at the time of consent&#xD;
&#xD;
          2. BMI ≥95th percentile&#xD;
&#xD;
          3. Diagnosis of GERD established prior to 7 days before receipt of study drug dose&#xD;
             defined as 1 or more of the following:&#xD;
&#xD;
               1. clinical symptoms consistent with GERD as determined by the investigator&#xD;
&#xD;
               2. a diagnosis of erosive esophagitis by endoscopy&#xD;
&#xD;
               3. esophageal biopsy with histopathology consistent with reflux esophagitis&#xD;
&#xD;
               4. abnormal pH-metry consistent with reflux esophagitis&#xD;
&#xD;
               5. other test result consistent with GERD&#xD;
&#xD;
          4. Written informed consent from the parent or legally authorized representative/guardian&#xD;
             and participant assent per local IRB recommendation of age-appropriate consent and&#xD;
             assent requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of pantoprazole, lansoprazole, omeprazole, esomeprazole or rabeprazole within 48&#xD;
             hours prior to dose of study drug&#xD;
&#xD;
          2. Use of fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, topiramate,&#xD;
             valproic acid, phenobarbital, carbamazepine, erythromycin, clarithromycin, grapefruit&#xD;
             juice, verapamil, diltiazem, cimetidine, St. John's Wort, rifampin, rifapentine within&#xD;
             seven days prior to dose of study drug&#xD;
&#xD;
          3. Consumption of food after midnight on the day of the baseline visit&#xD;
&#xD;
          4. Symptomatic asthma&#xD;
&#xD;
          5. Type I diabetes&#xD;
&#xD;
          6. History of adverse reaction to PPI&#xD;
&#xD;
          7. Impaired hepatic activity as defined as any of the following: AST ≥150 IU/L, ALT ≥150&#xD;
             IU/L, total bilirubin ≥2.0 mg/dl, or alkaline phosphatase ≥600 IU/L&#xD;
&#xD;
          8. Serum creatinine ≥2.0 mg/dL&#xD;
&#xD;
          9. For females of childbearing potential, a positive pregnancy test result&#xD;
&#xD;
         10. Known infection with hepatitis B, C, or HIV&#xD;
&#xD;
         11. Any other condition that, in the opinion of the principal investigator, makes&#xD;
             participation unadvised or unsafe.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phillip B Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Clinical Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>September 24, 2018</results_first_submitted>
  <results_first_submitted_qc>August 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2019</results_first_posted>
  <last_update_submitted>September 9, 2019</last_update_submitted>
  <last_update_submitted_qc>September 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>Phillip Brian Smith</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>obese</keyword>
  <keyword>children</keyword>
  <keyword>adolescents</keyword>
  <keyword>GERD</keyword>
  <keyword>pharmacokinetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pantoprazole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The first participant for this study began on 8-July-2014. The last participant to complete the study was on 13-September-2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Pantoprazole 6-11 Year Old</title>
          <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
        </group>
        <group group_id="P2">
          <title>Pantoprazole 12-17 Year Old</title>
          <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pantoprazole 6-11 Year Old</title>
          <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
        </group>
        <group group_id="B2">
          <title>Pantoprazole 12-17 Year Old</title>
          <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10" spread="2"/>
                    <measurement group_id="B2" value="15" spread="2"/>
                    <measurement group_id="B3" value="12" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.5" spread="23.7"/>
                    <measurement group_id="B2" value="97.9" spread="19.6"/>
                    <measurement group_id="B3" value="80.6" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight Percentile</title>
          <units>percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96.8" spread="3.6"/>
                    <measurement group_id="B2" value="97.9" spread="3.4"/>
                    <measurement group_id="B3" value="97.4" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="144.4" spread="13.9"/>
                    <measurement group_id="B2" value="166.6" spread="7.4"/>
                    <measurement group_id="B3" value="156.3" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height Percentile</title>
          <units>percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.3" spread="28.9"/>
                    <measurement group_id="B2" value="60.9" spread="29.7"/>
                    <measurement group_id="B3" value="62.9" spread="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.0" spread="5.8"/>
                    <measurement group_id="B2" value="35.0" spread="5.0"/>
                    <measurement group_id="B3" value="31.7" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI Percentile</title>
          <units>percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98" spread="1"/>
                    <measurement group_id="B2" value="98" spread="1"/>
                    <measurement group_id="B3" value="98" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).</title>
        <description>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, &amp; 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.</description>
        <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
        <population>All participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>same as the participant flow wording.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>same as participant flow wording.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).</title>
          <description>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, &amp; 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.</description>
          <population>All participants with evaluable data.</population>
          <units>mcg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.27" spread="1.43"/>
                    <measurement group_id="O2" value="4.1" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).</title>
        <description>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, &amp; 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.</description>
        <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
        <population>All participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).</title>
          <description>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, &amp; 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.</description>
          <population>All participants with evaluable data.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.5" upper_limit="3"/>
                    <measurement group_id="O2" value="2.5" lower_limit="1.5" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PK Sampling</title>
        <description>Total number of fresh plasma samples (all participants)</description>
        <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</time_frame>
        <population>All participants with evaluable data</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
        </group_list>
        <measure>
          <title>PK Sampling</title>
          <description>Total number of fresh plasma samples (all participants)</description>
          <population>All participants with evaluable data</population>
          <units>Plasma samples</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Plasma samples</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Plasma samples</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
                <count group_id="O2" value="235"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="2"/>
                    <measurement group_id="O2" value="11" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Drug Concentration in Plasma Samples</title>
        <description>Concentration of panto in plasma and concentration of panto sulfone in plasma</description>
        <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</time_frame>
        <population>All participants with evaluable data</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>Edit to include: dosing and any info about the participants experience and how they were treated.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>same as other arm description</description>
          </group>
        </group_list>
        <measure>
          <title>Drug Concentration in Plasma Samples</title>
          <description>Concentration of panto in plasma and concentration of panto sulfone in plasma</description>
          <population>All participants with evaluable data</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>plasma samples</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>plasma samples</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
                <count group_id="O2" value="235"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pantoprazole</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>plasma samples</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1558" spread="1584.6"/>
                    <measurement group_id="O2" value="1626.1" spread="1545.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pantoprazole Sulfone</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>plasma samples</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" spread="49.1"/>
                    <measurement group_id="O2" value="88.7" spread="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).</title>
        <description>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, &amp; 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.</description>
        <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
        <population>All participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).</title>
          <description>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, &amp; 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.</description>
          <population>All participants with evaluable data.</population>
          <units>mcg*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.87" spread="4.00"/>
                    <measurement group_id="O2" value="11.56" spread="4.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).</title>
        <description>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, &amp; 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.</description>
        <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
        <population>All participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).</title>
          <description>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, &amp; 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.</description>
          <population>All participants with evaluable data.</population>
          <units>mcg*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.73" spread="2.48"/>
                    <measurement group_id="O2" value="6.82" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).</title>
        <description>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, &amp; 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.</description>
        <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
        <population>All participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).</title>
          <description>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, &amp; 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.</description>
          <population>All participants with evaluable data.</population>
          <units>l/h/kg TBW</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.07"/>
                    <measurement group_id="O2" value="0.10" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).</title>
        <description>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, &amp; 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.</description>
        <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
        <population>All participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).</title>
          <description>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, &amp; 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.</description>
          <population>All participants with evaluable data.</population>
          <units>L/kg TBW</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="0.05"/>
                    <measurement group_id="O2" value="0.14" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).</title>
        <description>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, &amp; 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.</description>
        <time_frame>pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, &amp; 8 hours</time_frame>
        <population>All participants with evaluable data.</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole 6-11 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole 12-17 Year Old</title>
            <description>The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping.&#xD;
During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at 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. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).</title>
          <description>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, &amp; 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.</description>
          <population>All participants with evaluable data.</population>
          <units>L/kg LBW</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.09"/>
                    <measurement group_id="O2" value="0.25" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype</title>
        <description>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).</description>
        <time_frame>0, 1, 2, 3, 4, 6, 8, 12 hours post-dose</time_frame>
        <population>Total analyzed #participants is 38. Total #participants in age groups is 37 excluding one poor-metabolizer.&#xD;
Poor metabolizer is defined as a participant who had *2/*2 alleles; intermediate metabolizer is defined as a participant who had *1/*2 or *2/*17 alleles; extensive metabolizer is defined as a participant who had *1/*1 or *1/*17 alleles.</population>
        <group_list>
          <group group_id="O1">
            <title>*2*2 Allele</title>
            <description>Poor metabolizer</description>
          </group>
          <group group_id="O2">
            <title>*1/*2 Allele</title>
            <description>Intermediate Metabolizer</description>
          </group>
          <group group_id="O3">
            <title>*1/*1 Allele or *1/*17 Allele</title>
            <description>Extensive Metabolizer</description>
          </group>
        </group_list>
        <measure>
          <title>The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype</title>
          <description>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).</description>
          <population>Total analyzed #participants is 38. Total #participants in age groups is 37 excluding one poor-metabolizer.&#xD;
Poor metabolizer is defined as a participant who had *2/*2 alleles; intermediate metabolizer is defined as a participant who had *1/*2 or *2/*17 alleles; extensive metabolizer is defined as a participant who had *1/*1 or *1/*17 alleles.</population>
          <units>L/h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" lower_limit="NA" upper_limit="NA">1 participant only</measurement>
                    <measurement group_id="O2" value="6.00" lower_limit="2.64" upper_limit="11.62"/>
                    <measurement group_id="O3" value="8.97" lower_limit="4.66" upper_limit="16.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were followed up to 10 days post study dose.</time_frame>
      <desc>An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)</desc>
      <group_list>
        <group group_id="E1">
          <title>6-11 Year Old Adverse Events</title>
          <description>Study participants were selected from obese children and adolescents ranging in age from 6 17 years (inclusive) and seen in the outpatient clinic for the diagnosis or treatment of GERD. The target enrollment was 40 participants (20 participants 6-11 years of age and up to 20 participants 12 17 years of age). Potential study participants could come from any outpatient clinical setting within participating institutions where children with GERD were seen for evaluation and/or treatment.</description>
        </group>
        <group group_id="E2">
          <title>12-17 Year Old Adverse Events</title>
          <description>Study participants were selected from obese children and adolescents ranging in age from 6 17 years (inclusive) and seen in the outpatient clinic for the diagnosis or treatment of GERD. The target enrollment was 40 participants (20 participants 6-11 years of age and up to 20 participants 12 17 years of age). Potential study participants could come from any outpatient clinical setting within participating institutions where children with GERD were seen for evaluation and/or treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chad Livingston</name_or_title>
      <organization>Duke Clinical Research Institute</organization>
      <phone>919-668-1935</phone>
      <email>chad.livingston@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02186652
org study id: Pro00048765
nct id: NCT02186652
lead sponsor: 
collaborator: 
has dmc: Yes
Multicenter, comparative single-dose pharmacokinetic (PK) study
Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with
      gastroesophageal reflux disease (GERD) following administration of an oral dose of
      pantoprazole.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: Total number of fresh plasma samples (all participants)
measure: 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
description: Concentration of panto in plasma and concentration of panto sulfone in plasma
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
measure: The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype
time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose
description: 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).
arm group label: Pantoprazole
arm group type: Other
intervention type: Drug
intervention name: Pantoprazole
arm group label: Pantoprazole
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Phillip B Smith, MD
role: Principal Investigator
affiliation: Duke Clinical Research Institute
facility: 
facility: 
facility: 
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country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Duke University
investigator full name: Phillip Brian Smith
investigator title: Principal Investigator
mesh term: Gastroesophageal Reflux
mesh term: Pantoprazole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 