<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/NCT01733108</url>
  </required_header>
  <id_info>
    <org_study_id>CR014872</org_study_id>
    <secondary_id>28431754DIA1004</secondary_id>
    <nct_id>NCT01733108</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers</brief_title>
  <official_title>An Open-Label Drug-Drug Interaction Study in Healthy Subjects to Explore the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics and Safety of Single Doses of Glyburide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Pharmaceutical Research &amp; Development, L.L.C.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson Pharmaceutical Research &amp; Development, L.L.C.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)&#xD;
      affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how&#xD;
      the drug affects the body) of a single dose of glyburide.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be an open-label (all volunteers and study staff know the identity of the&#xD;
      assigned treatment), single-center, fixed-sequence study (all volunteers receive the same&#xD;
      medication on the same days) to determine how canagliflozin (a drug currently being&#xD;
      investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and&#xD;
      pharmacodynamics of glyburide (a blood glucose-lowering agent used to treat patients with&#xD;
      diabetes). The study will consist of 3 phases; a screening phase, an open-label treatment&#xD;
      phase, and an end-of-study (or follow-up) phase. During the open-label treatment phase, each&#xD;
      volunteer will receive a single 1.25 mg dose of glyburide on Day 1, followed by 200 mg&#xD;
      canagliflozin once daily on Days 4 through 8. On Day 9 volunteers will receive both glyburide&#xD;
      1.25 mg and canagliflozin 200 mg. Each volunteer will participate in the study for&#xD;
      approximately 40 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2008</start_date>
  <completion_date type="Actual">September 2008</completion_date>
  <primary_completion_date type="Actual">September 2008</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentrations of glyburide</measure>
    <time_frame>Up to Day 12</time_frame>
    <description>Comparison of plasma concentrations of glyburide following administration of a single dose of glyburide alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between glyburide and canagliflozin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentrations of glyburide metabolites</measure>
    <time_frame>Up to Day 12</time_frame>
    <description>Comparison of plasma concentrations of glyburide metabolites following administration of a single dose of glyburide alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between glyburide and canagliflozin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma glucose concentrations</measure>
    <time_frame>Day -1 (Baseline) up to Day 9</time_frame>
    <description>Plasma glucose concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes in plasma glucose) between glyburide and canagliflozin. The area under the plasma glucose concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma insulin concentrations</measure>
    <time_frame>Day -1 (Baseline) up to Day 9</time_frame>
    <description>Plasma insulin concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes to plasma insulin) between glyburide and canagliflozin. The area under the plasma insulin concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in plasma C-peptide concentrations</measure>
    <time_frame>Day -1 (Baseline) up to Day 9</time_frame>
    <description>Plasma C-peptide is formed during the body's production of insulin. Plasma C-peptide concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes to plasma C-peptide) between glyburide and canaglifloxin. The area under the plasma C-peptide concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Canagliflozin (JNJ-28431754) + glyburide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each volunteer will receive a single dose of glyburide on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 4 through 8. On Day 9 volunteers will receive a single dose of glyburide in combination with a single dose of canagliflozin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glyburide</intervention_name>
    <description>One 1.25 mg tablet taken orally (by mouth) on Day 1 and Day 9.</description>
    <arm_group_label>Canagliflozin (JNJ-28431754) + glyburide</arm_group_label>
    <other_name>Micronase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canagliflozin (JNJ-28431754)</intervention_name>
    <description>One 200 mg tablet taken orally (by mouth) on Days 4 through 9.</description>
    <arm_group_label>Canagliflozin (JNJ-28431754) + glyburide</arm_group_label>
    <other_name>JNJ-28431754</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteer must have a body mass index (BMI = weight in kg/height in m2) between 18 and&#xD;
             30 kg/m2 (inclusive) and body weight not less than 50 kg Exclusion Criteria:&#xD;
&#xD;
          -  Volunteer has a history of or currently active illness considered to be clinically&#xD;
             significant by the Investigator or any other illness that the Investigator considers&#xD;
             should exclude the patient from the study or that could interfere with the&#xD;
             interpretation of the study results&#xD;
&#xD;
          -  Volunteer has a fasting plasma glucose &lt; 100 mg/dL (as measured by oral glucose&#xD;
             tolerance test) and a 2-hour plasma glucose &lt;= 140 mg/dL&#xD;
&#xD;
          -  History of smoking or use of nicotine-containing substances within the previous 6&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johnson &amp; Johnson Pharmaceutical Research &amp; Development, L.L. C. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Johnson &amp; Johnson Pharmaceutical Research &amp; Development, L.L.C.</affiliation>
  </overall_official>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>December 11, 2012</last_update_submitted>
  <last_update_submitted_qc>December 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Canagliflozin (JNJ-28431754)</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <keyword>Glyburide (MICRONASE)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Canagliflozin</mesh_term>
    <mesh_term>Glyburide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01733108
org study id: CR014872
secondary id: 28431754DIA1004
nct id: NCT01733108
lead sponsor: 
has dmc: No
The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754)
      affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how
      the drug affects the body) of a single dose of glyburide.
This study will be an open-label (all volunteers and study staff know the identity of the
      assigned treatment), single-center, fixed-sequence study (all volunteers receive the same
      medication on the same days) to determine how canagliflozin (a drug currently being
      investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and
      pharmacodynamics of glyburide (a blood glucose-lowering agent used to treat patients with
      diabetes). The study will consist of 3 phases; a screening phase, an open-label treatment
      phase, and an end-of-study (or follow-up) phase. During the open-label treatment phase, each
      volunteer will receive a single 1.25 mg dose of glyburide on Day 1, followed by 200 mg
      canagliflozin once daily on Days 4 through 8. On Day 9 volunteers will receive both glyburide
      1.25 mg and canagliflozin 200 mg. Each volunteer will participate in the study for
      approximately 40 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma concentrations of glyburide
time frame: Up to Day 12
description: Comparison of plasma concentrations of glyburide following administration of a single dose of glyburide alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between glyburide and canagliflozin.
measure: Plasma concentrations of glyburide metabolites
time frame: Up to Day 12
description: Comparison of plasma concentrations of glyburide metabolites following administration of a single dose of glyburide alone or in combination with multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between glyburide and canagliflozin.
measure: Change from baseline in plasma glucose concentrations
time frame: Day -1 (Baseline) up to Day 9
description: Plasma glucose concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes in plasma glucose) between glyburide and canagliflozin. The area under the plasma glucose concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.
measure: Change from baseline in plasma insulin concentrations
time frame: Day -1 (Baseline) up to Day 9
description: Plasma insulin concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes to plasma insulin) between glyburide and canagliflozin. The area under the plasma insulin concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.
measure: Change from baseline in plasma C-peptide concentrations
time frame: Day -1 (Baseline) up to Day 9
description: Plasma C-peptide is formed during the body's production of insulin. Plasma C-peptide concentrations following the administration of a single dose of glyburide after the administration of multiple doses of canagliflozin (JNJ-28431754) will be used to determine whether there is a pharmacodynamic interaction (changes to plasma C-peptide) between glyburide and canaglifloxin. The area under the plasma C-peptide concentration-time curve (AUC) will be used as the key pharmacodynamic parameter.
arm group label: Canagliflozin (JNJ-28431754) + glyburide
arm group type: Experimental
description: Each volunteer will receive a single dose of glyburide on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 4 through 8. On Day 9 volunteers will receive a single dose of glyburide in combination with a single dose of canagliflozin.
intervention type: Drug
intervention name: Glyburide
description: One 1.25 mg tablet taken orally (by mouth) on Day 1 and Day 9.
arm group label: Canagliflozin (JNJ-28431754) + glyburide
other name: Micronase
intervention type: Drug
intervention name: Canagliflozin (JNJ-28431754)
description: One 200 mg tablet taken orally (by mouth) on Days 4 through 9.
arm group label: Canagliflozin (JNJ-28431754) + glyburide
other name: JNJ-28431754
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: Study Director
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
responsible party type: Sponsor
mesh term: Canagliflozin
mesh term: Glyburide