<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/NCT01707316</url>
  </required_header>
  <id_info>
    <org_study_id>CR100923</org_study_id>
    <secondary_id>28431754DIA1026</secondary_id>
    <nct_id>NCT01707316</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin in Healthy Chinese Volunteers</brief_title>
  <official_title>A Double-Blind, Randomized, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of JNJ-28431754 (Canagliflozin) in Healthy Chinese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetics (what the body does to the&#xD;
      medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754&#xD;
      (canagliflozin) and its main metabolites (break-down products) following 2 different doses of&#xD;
      canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will&#xD;
      also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a double-blind (neither the Investigator nor volunteer knows the assigned&#xD;
      treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the&#xD;
      study treatments is inactive), single-dose, 3-way cross over study (all volunteers will&#xD;
      receive each of the 3 treatments but in a different order) in healthy Chinese volunteers.&#xD;
      Volunteers will be assigned to 1 of 3 treatment sequence groups (ABC, BCA, or CAB). The&#xD;
      treatment sequence will be decided by randomization. Treatment A will be a single oral (by&#xD;
      mouth) dose of 100 mg of canagliflozin. Treatment B will be a single oral dose of 300 mg of&#xD;
      canagliflozin. Treatment C will be a single oral dose of placebo (inactive medication). Each&#xD;
      treatment will be given during a treatment period of 5 days duration; each treatment period&#xD;
      will be separated by a washout period (a time period with no medication) of at least 10 days.&#xD;
      Canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus&#xD;
      (T2DM).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose</measure>
    <time_frame>Up to Day 4</time_frame>
    <description>Plasma concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug) for canagliflozin and its major metabolites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose</measure>
    <time_frame>Up to Day 2</time_frame>
    <description>Urine concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters for canagliflozin and its major metabolites.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal threshold for glucose excretion following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)</measure>
    <time_frame>Up to Day 2</time_frame>
    <description>Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine glucose excretion (UGE) following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)</measure>
    <time_frame>Up to Day 2</time_frame>
    <description>UGE is equal to the amount of glucose excreted into the urine over defined time intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean plasma glucose concentration following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)</measure>
    <time_frame>Up to Day 2</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Sequence 1: Treatment A-B-C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2: Treatment B-C-A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3: Treatment C-A-B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment A: Canagliflozin 100 mg</intervention_name>
    <description>Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.</description>
    <arm_group_label>Sequence 1: Treatment A-B-C</arm_group_label>
    <arm_group_label>Sequence 2: Treatment B-C-A</arm_group_label>
    <arm_group_label>Sequence 3: Treatment C-A-B</arm_group_label>
    <other_name>JNJ-28431754</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Treatment B: Canagliflozin 300 mg</intervention_name>
    <description>Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.</description>
    <arm_group_label>Sequence 1: Treatment A-B-C</arm_group_label>
    <arm_group_label>Sequence 2: Treatment B-C-A</arm_group_label>
    <arm_group_label>Sequence 3: Treatment C-A-B</arm_group_label>
    <other_name>JNJ-28431754</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment C: Placebo</intervention_name>
    <description>Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.</description>
    <arm_group_label>Sequence 1: Treatment A-B-C</arm_group_label>
    <arm_group_label>Sequence 2: Treatment B-C-A</arm_group_label>
    <arm_group_label>Sequence 3: Treatment C-A-B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers must be non-smokers for at least 6 months before first study drug&#xD;
             administration&#xD;
&#xD;
          -  Volunteers must consume no more than 4 to 5 cups of coffee or tea or 8 cans of cola&#xD;
             each day&#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;
          -  Female volunteer is breast-feeding&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>February 18, 2013</last_update_submitted>
  <last_update_submitted_qc>February 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>JNJ-28431754</keyword>
  <keyword>Canagliflozin</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Canagliflozin</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/NCT01707316
org study id: CR100923
secondary id: 28431754DIA1026
nct id: NCT01707316
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the
      medication) and pharmacodynamics (the action of the medication on the body) of JNJ-28431754
      (canagliflozin) and its main metabolites (break-down products) following 2 different doses of
      canagliflozin in healthy Chinese volunteers. Safety and tolerability of canagliflozin will
      also be assessed.
This study will be a double-blind (neither the Investigator nor volunteer knows the assigned
      treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the
      study treatments is inactive), single-dose, 3-way cross over study (all volunteers will
      receive each of the 3 treatments but in a different order) in healthy Chinese volunteers.
      Volunteers will be assigned to 1 of 3 treatment sequence groups (ABC, BCA, or CAB). The
      treatment sequence will be decided by randomization. Treatment A will be a single oral (by
      mouth) dose of 100 mg of canagliflozin. Treatment B will be a single oral dose of 300 mg of
      canagliflozin. Treatment C will be a single oral dose of placebo (inactive medication). Each
      treatment will be given during a treatment period of 5 days duration; each treatment period
      will be separated by a washout period (a time period with no medication) of at least 10 days.
      Canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus
      (T2DM).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Plasma concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose
time frame: Up to Day 4
description: Plasma concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters (measurements that explore what the body does to the drug) for canagliflozin and its major metabolites.
measure: Urine concentrations of canagliflozin and its major metabolites following a single 100 mg and 300 mg dose
time frame: Up to Day 2
description: Urine concentrations of canagliflozin and its major metabolites will be used to determine pharmacokinetic parameters for canagliflozin and its major metabolites.
measure: Renal threshold for glucose excretion following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)
time frame: Up to Day 2
description: Renal threshold is defined as the plasma glucose concentration above which glucose is excreted in the urine.
measure: Urine glucose excretion (UGE) following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)
time frame: Up to Day 2
description: UGE is equal to the amount of glucose excreted into the urine over defined time intervals.
measure: Mean plasma glucose concentration following a single 100 mg dose of canagliflozin, 300 mg dose of canagliflozin, and placebo (inactive medication)
time frame: Up to Day 2
arm group label: Sequence 1: Treatment A-B-C
arm group type: Experimental
description: The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
arm group label: Sequence 2: Treatment B-C-A
arm group type: Experimental
description: The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
arm group label: Sequence 3: Treatment C-A-B
arm group type: Experimental
description: The study consists of 3 single-dose treatment periods. Each treatment period will be 5 days in duration. Successive treatment periods will be separated by a washout period (with no medication) of 10 days.
intervention type: Drug
intervention name: Treatment A: Canagliflozin 100 mg
description: Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
arm group label: Sequence 1: Treatment A-B-C
arm group label: Sequence 2: Treatment B-C-A
arm group label: Sequence 3: Treatment C-A-B
other name: JNJ-28431754
intervention type: Drug
intervention name: Treatment B: Canagliflozin 300 mg
description: Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
arm group label: Sequence 1: Treatment A-B-C
arm group label: Sequence 2: Treatment B-C-A
arm group label: Sequence 3: Treatment C-A-B
other name: JNJ-28431754
intervention type: Other
intervention name: Treatment C: Placebo
description: Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
arm group label: Sequence 1: Treatment A-B-C
arm group label: Sequence 2: Treatment B-C-A
arm group label: Sequence 3: Treatment C-A-B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: China
responsible party type: Sponsor
mesh term: Canagliflozin