<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/NCT01714193</url>
  </required_header>
  <id_info>
    <org_study_id>CR014755</org_study_id>
    <secondary_id>28431754DIA1002</secondary_id>
    <nct_id>NCT01714193</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of an Oral Contraceptive in Healthy Volunteers</brief_title>
  <official_title>An Open-label Drug-Drug Interaction Study in Healthy Female Subjects to Explore the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics and Safety of Single Doses of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel</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 investigate whether there is a drug-drug interaction between&#xD;
      multiple doses of canagliflozin (JNJ-28431754) and single doses of an oral contraceptive&#xD;
      containing ethinyl estradiol and levonorgestrel. The safety and tolerability of canagliflozin&#xD;
      will also be assessed in healthy volunteers.&#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 (ie,&#xD;
      how the body affects the drug) of an oral contraceptive containing ethinyl estradiol and&#xD;
      levonorgestrel. The study will consist of 3 phases; a screening phase, an open-label&#xD;
      treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in&#xD;
      the study for approximately 33 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">March 2008</completion_date>
  <primary_completion_date type="Actual">March 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 ethinyl estradiol and levonorgestrel</measure>
    <time_frame>Up to Day 12</time_frame>
    <description>Comparison of plasma concentrations of ethinyl estradiol and levonorgestrel, before and after administration of multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between multiple doses of canagliflozin and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of canagliflozin (JNJ-28431754)</measure>
    <time_frame>Days 8 and 9</time_frame>
    <description>Comparison of plasma concentrations of canagliflozin (JNJ-28431754) before and after administration of a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel. This will be used to determine whether there is a pharmacokinetic interaction between multiple doses of canagliflozin and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Canagliflozin + oral contraceptive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each volunteer will receive a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel 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 an oral contraceptive containing ethinyl estradiol and levonorgestrel in combination with a single dose of canagliflozin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral contraceptive</intervention_name>
    <description>One tablet (0.150 mg of levonorgestrel and 0.030 mg of ethinyl estradiol) taken orally (by mouth) on Day 1 and Day 9.</description>
    <arm_group_label>Canagliflozin + oral contraceptive</arm_group_label>
    <other_name>Levora</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 + oral contraceptive</arm_group_label>
    <other_name>JNJ-28431754</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteer must have a body mass index (weight [kg]/height [m2]) between 18 and 30&#xD;
             kg/m2 (inclusive), and body weight not less than 50 kg&#xD;
&#xD;
          -  Volunteer must be a non-smoker (has not used tobacco or nicotine products in 6 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or currently active illness considered to be clinically significant by the&#xD;
             Investigator or any other illness that the Investigator considers should exclude the&#xD;
             patient from the study or that could interfere with the interpretation of the study&#xD;
             results&#xD;
&#xD;
          -  History of, or presence of, disorders commonly accepted as contraindications to sex&#xD;
             hormonal therapy and contraindications to therapy with combined oral contraceptives&#xD;
&#xD;
          -  Volunteer has used, or is currently using, any hormonal contraceptive within 30 days&#xD;
             of admission to the study center or has received Depo Provera (or other combined&#xD;
             contraceptive injection or hormonal contraceptive implant) in the 6 months prior to&#xD;
             screening&#xD;
&#xD;
          -  Volunteer is breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>November 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>November 16, 2012</last_update_submitted>
  <last_update_submitted_qc>November 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 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>Contraceptives, Oral</keyword>
  <keyword>Ethinyl Estradiol</keyword>
  <keyword>Levonorgestrel</keyword>
  <keyword>LEVORA</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Canagliflozin</mesh_term>
    <mesh_term>Contraceptive Agents</mesh_term>
    <mesh_term>Contraceptives, Oral</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/NCT01714193
org study id: CR014755
secondary id: 28431754DIA1002
nct id: NCT01714193
lead sponsor: 
has dmc: No
The purpose of this study is to investigate whether there is a drug-drug interaction between
      multiple doses of canagliflozin (JNJ-28431754) and single doses of an oral contraceptive
      containing ethinyl estradiol and levonorgestrel. 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 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 (ie,
      how the body affects the drug) of an oral contraceptive containing ethinyl estradiol and
      levonorgestrel. 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 33 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma concentrations of ethinyl estradiol and levonorgestrel
time frame: Up to Day 12
description: Comparison of plasma concentrations of ethinyl estradiol and levonorgestrel, before and after administration of multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between multiple doses of canagliflozin and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel.
measure: Plasma concentrations of canagliflozin (JNJ-28431754)
time frame: Days 8 and 9
description: Comparison of plasma concentrations of canagliflozin (JNJ-28431754) before and after administration of a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel. This will be used to determine whether there is a pharmacokinetic interaction between multiple doses of canagliflozin and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel.
arm group label: Canagliflozin + oral contraceptive
arm group type: Experimental
description: Each volunteer will receive a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel 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 an oral contraceptive containing ethinyl estradiol and levonorgestrel in combination with a single dose of canagliflozin.
intervention type: Drug
intervention name: Oral contraceptive
description: One tablet (0.150 mg of levonorgestrel and 0.030 mg of ethinyl estradiol) taken orally (by mouth) on Day 1 and Day 9.
arm group label: Canagliflozin + oral contraceptive
other name: Levora
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 + oral contraceptive
other name: JNJ-28431754
criteria: 
gender: Female
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: Contraceptive Agents
mesh term: Contraceptives, Oral