<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/NCT01718652</url>
  </required_header>
  <id_info>
    <org_study_id>CR017926</org_study_id>
    <secondary_id>28431754DIA1031</secondary_id>
    <secondary_id>2010-021854-21</secondary_id>
    <nct_id>NCT01718652</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers</brief_title>
  <official_title>An Open-Label, Single Sequence Study to Assess the Effect of a Single Dose of Cyclosporine on the Steady-State Pharmacokinetics of JNJ-28431754 (Canagliflozin) in Healthy Adult Subjects</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 a single dose of cyclosporin affects the&#xD;
      pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin&#xD;
      (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in healthy&#xD;
      volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be an open label (all volunteers and study staff know the identity of&#xD;
      assigned treatments), single-center, multiple-dose study to determine how cyclosporin (a drug&#xD;
      which reduces the activity of a patient's immune system) affects the pharmacokinetics of&#xD;
      canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes&#xD;
      mellitus). 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. Each volunteer will participate in the study&#xD;
      for approximately 47 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">April 2011</completion_date>
  <primary_completion_date type="Actual">April 2011</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 canagliflozin (JNJ-28431754)</measure>
    <time_frame>Day 7 and Day 8</time_frame>
    <description>Comparison of the maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve (AUC) of canagliflozin (JNJ-28431754) (measures of the body's exposure to canagliflozin) before and after administration of a single dose of cyclosporine. This will be used to determine whether there is a pharmacokinetic interaction between cyclosporine and canagliflozin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of volunteers with adverse events as a measure of safety and tolerability</measure>
    <time_frame>Up to 47 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Canagliflozin + cyclosporine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each volunteer will receive canagliflozin (JNJ-28431754) once daily on Days 1 through 8 with a single dose of cyclosporine on Day 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canagliflozin (JNJ-28431754)</intervention_name>
    <description>One 300 mg capsule-shaped tablet taken orally (by mouth) on Days 1 through 8.</description>
    <arm_group_label>Canagliflozin + cyclosporine</arm_group_label>
    <other_name>JNJ-28431754</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclosporine</intervention_name>
    <description>Four 100 mg capsules (400 mg total dose) taken orally 30 minutes before the last dose of canagliflozin (JNJ-28431754) on Day 8.</description>
    <arm_group_label>Canagliflozin + cyclosporine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have body mass index between 18 and 30 kg/m2 (inclusive), and body weight not&#xD;
             less than 50 kg&#xD;
&#xD;
          -  If a woman, must be either postmenopausal, defined as no spontaneous menses for at&#xD;
             least 18 months or amenorrhea for at least 6 months or surgically sterile (have had a&#xD;
             hysterectomy, or tubal ligation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of smoking or use of nicotine-containing substances within the previous 2&#xD;
             months&#xD;
&#xD;
          -  Have had history of or current medical illness considered to be clinically significant&#xD;
             by the Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 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>
  <location>
    <facility>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>November 22, 2012</last_update_submitted>
  <last_update_submitted_qc>November 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 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>Cyclosporine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Canagliflozin</mesh_term>
    <mesh_term>Cyclosporine</mesh_term>
    <mesh_term>Cyclosporins</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/NCT01718652
org study id: CR017926
secondary id: 28431754DIA1031
secondary id: 2010-021854-21
nct id: NCT01718652
lead sponsor: 
has dmc: No
The purpose of this study is to determine how a single dose of cyclosporin affects the
      pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin
      (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in healthy
      volunteers.
This study will be an open label (all volunteers and study staff know the identity of
      assigned treatments), single-center, multiple-dose study to determine how cyclosporin (a drug
      which reduces the activity of a patient's immune system) affects the pharmacokinetics of
      canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes
      mellitus). The study will consist of 3 phases: a screening phase, an open-label treatment
      phase, and an end-of study (or follow-up) phase. Each volunteer will participate in the study
      for approximately 47 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma concentrations of canagliflozin (JNJ-28431754)
time frame: Day 7 and Day 8
description: Comparison of the maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve (AUC) of canagliflozin (JNJ-28431754) (measures of the body's exposure to canagliflozin) before and after administration of a single dose of cyclosporine. This will be used to determine whether there is a pharmacokinetic interaction between cyclosporine and canagliflozin.
measure: The number of volunteers with adverse events as a measure of safety and tolerability
time frame: Up to 47 days
arm group label: Canagliflozin + cyclosporine
arm group type: Experimental
description: Each volunteer will receive canagliflozin (JNJ-28431754) once daily on Days 1 through 8 with a single dose of cyclosporine on Day 7.
intervention type: Drug
intervention name: Canagliflozin (JNJ-28431754)
description: One 300 mg capsule-shaped tablet taken orally (by mouth) on Days 1 through 8.
arm group label: Canagliflozin + cyclosporine
other name: JNJ-28431754
intervention type: Drug
intervention name: Cyclosporine
description: Four 100 mg capsules (400 mg total dose) taken orally 30 minutes before the last dose of canagliflozin (JNJ-28431754) on Day 8.
arm group label: Canagliflozin + cyclosporine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 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.
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Canagliflozin
mesh term: Cyclosporine
mesh term: Cyclosporins