<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/NCT01714206</url>
  </required_header>
  <id_info>
    <org_study_id>CR016465</org_study_id>
    <secondary_id>28431754DIA1014</secondary_id>
    <nct_id>NCT01714206</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.</brief_title>
  <official_title>An Open-Label, 2-Period, Crossover Study to Evaluate the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics of Multiple Doses of Digoxin in Healthy 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 multiple doses of canagliflozin (JNJ-28431754)&#xD;
      affect the pharmacokinetics (ie, how the body affects the drug) of multiple doses of digoxin.&#xD;
      The safety and tolerability of canagliflozin 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), randomized (the treatment is assigned by chance), multiple dose,&#xD;
      cross-over study (all volunteers will switch from one treatment to another) to determine how&#xD;
      canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes&#xD;
      mellitus) affects the pharmacokinetics of digoxin (a drug used to treat various heart&#xD;
      conditions). Volunteers will be randomly assigned to 1 of 2 treatment sequence groups: Group&#xD;
      AB or Group BA. Volunteers assigned to Group AB will be given Treatment A: digoxin once a day&#xD;
      for 7 days. Volunteers assigned to Group BA will be given Treatment B: digoxin and&#xD;
      canagliflozin once a day for 7 days. A washout period (when no medication is given) of at&#xD;
      least 14 days will follow the first 7-day treatment period. Following the washout period,&#xD;
      volunteers will be assigned to the treatment that they did not receive during the first&#xD;
      treatment period. This second treatment period will last for 7 days. Each volunteer will&#xD;
      participate in the study for approximately 60 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">September 2009</completion_date>
  <primary_completion_date type="Actual">September 2009</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentration of digoxin</measure>
    <time_frame>Days 5 through 7</time_frame>
    <description>Comparison of plasma concentrations of digoxin following administration of digoxin alone (Treatment A) or in combination with canagliflozin (JNJ-28431754) (Treatment B). This will be used to determine whether there is a pharmacokinetic interaction between digoxin and canagliflozin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentration of digoxin</measure>
    <time_frame>Day 7</time_frame>
    <description>Comparison of the urine concentrations of digoxin following administration of digoxin alone (Treatment A) or in combination with canagliflozin (JNJ-28431754) (Treatment B). This will be used to determine whether there is a pharmacokinetic interaction between canagliflozin and digoxin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>There are no secondary outcome measures</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each volunteer will receive digoxin once daily on Days 1 through 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each volunteer will receive digoxin once daily on Days 1 through 7 in combination with canagliflozin (JNJ-28431754) once daily on Days 1 through 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin 0.5 mg</intervention_name>
    <description>Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.</description>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_label>Treatment B</arm_group_label>
    <other_name>Lanoxin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Digoxin 0.25 mg</intervention_name>
    <description>One 0.25 mg tablet taken orally on Days 2 through 7.</description>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_label>Treatment B</arm_group_label>
    <other_name>Lanoxin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canagliflozin (JNJ-28431754)</intervention_name>
    <description>One 300 mg tablet taken orally on Days 1 through 7.</description>
    <arm_group_label>Treatment B</arm_group_label>
    <other_name>JNJ-28431754</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18&#xD;
             and 30 kg/m2 (inclusive), and body weight not less than 50 kg&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
          -  History of, or current 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;
      </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>November 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 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>Digoxin (LANOXIN)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Canagliflozin</mesh_term>
    <mesh_term>Digoxin</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/NCT01714206
org study id: CR016465
secondary id: 28431754DIA1014
nct id: NCT01714206
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) of multiple doses of digoxin.
      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), randomized (the treatment is assigned by chance), multiple dose,
      cross-over study (all volunteers will switch from one treatment to another) to determine how
      canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes
      mellitus) affects the pharmacokinetics of digoxin (a drug used to treat various heart
      conditions). Volunteers will be randomly assigned to 1 of 2 treatment sequence groups: Group
      AB or Group BA. Volunteers assigned to Group AB will be given Treatment A: digoxin once a day
      for 7 days. Volunteers assigned to Group BA will be given Treatment B: digoxin and
      canagliflozin once a day for 7 days. A washout period (when no medication is given) of at
      least 14 days will follow the first 7-day treatment period. Following the washout period,
      volunteers will be assigned to the treatment that they did not receive during the first
      treatment period. This second treatment period will last for 7 days. Each volunteer will
      participate in the study for approximately 60 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma concentration of digoxin
time frame: Days 5 through 7
description: Comparison of plasma concentrations of digoxin following administration of digoxin alone (Treatment A) or in combination with canagliflozin (JNJ-28431754) (Treatment B). This will be used to determine whether there is a pharmacokinetic interaction between digoxin and canagliflozin.
measure: Urine concentration of digoxin
time frame: Day 7
description: Comparison of the urine concentrations of digoxin following administration of digoxin alone (Treatment A) or in combination with canagliflozin (JNJ-28431754) (Treatment B). This will be used to determine whether there is a pharmacokinetic interaction between canagliflozin and digoxin.
measure: There are no secondary outcome measures
arm group label: Treatment A
arm group type: Active Comparator
description: Each volunteer will receive digoxin once daily on Days 1 through 7.
arm group label: Treatment B
arm group type: Experimental
description: Each volunteer will receive digoxin once daily on Days 1 through 7 in combination with canagliflozin (JNJ-28431754) once daily on Days 1 through 7.
intervention type: Drug
intervention name: Digoxin 0.5 mg
description: Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.
arm group label: Treatment A
arm group label: Treatment B
other name: Lanoxin
intervention type: Drug
intervention name: Digoxin 0.25 mg
description: One 0.25 mg tablet taken orally on Days 2 through 7.
arm group label: Treatment A
arm group label: Treatment B
other name: Lanoxin
intervention type: Drug
intervention name: Canagliflozin (JNJ-28431754)
description: One 300 mg tablet taken orally on Days 1 through 7.
arm group label: Treatment B
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: Digoxin