<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/NCT01665638</url>
  </required_header>
  <id_info>
    <org_study_id>CR100800</org_study_id>
    <secondary_id>28431754DIA1049</secondary_id>
    <secondary_id>2012-001667-73</secondary_id>
    <nct_id>NCT01665638</nct_id>
  </id_info>
  <brief_title>Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers</brief_title>
  <official_title>A Double-Blind, Randomized, Placebo-Controlled, 2-Way Cross-Over Study to Evaluate the Effect of Single Dose Canagliflozin on Kinetics of C-Peptide in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen-Cilag International NV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess whether treatment with a single oral 300 mg dose of&#xD;
      canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a&#xD;
      protein released from the pancreas during insulin secretion) in healthy adult volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind (neither the volunteer nor the study doctor/staff will know the&#xD;
      identity of the assigned treatments) study to assess the effect of single oral (taken by&#xD;
      mouth) dose of canagliflozin on clearance (removal from the body) of C-peptide in healthy&#xD;
      adult volunteers. Healthy volunteers will be randomly (by chance) assigned to receive a&#xD;
      single oral dose of canagliflozin followed by a single oral dose of placebo (inactive&#xD;
      substance) or a single dose of placebo followed by a single dose of canagliflozin with a&#xD;
      period of 7-10 days between treatments. Healthy volunteers will also receive intravenous&#xD;
      (i.v.) infusion (injection in the vein) of somatostatin for 4 hours and a single dose i.v.&#xD;
      injection of synthetic human C-peptide following administration of canagliflozin or placebo&#xD;
      during each treatment period. Somatostatin will suppress the normal secretion of C-peptide, a&#xD;
      protein that is released from the pancreas during insulin secretion, so that the human&#xD;
      C-peptide administered to volunteers can be accurately measured. The total study duration for&#xD;
      each volunteer will be approximately 44 days. During the study, blood and urine samples will&#xD;
      be drawn (collected) for clinical laboratory evaluations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 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>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in C-peptide kinetic parameters</measure>
    <time_frame>Before and after study drug administration on Day 1 of Treatment Periods 1 and 2</time_frame>
    <description>Parameters are volume of distribution (Vd), clearance (CL) and half life (T1/2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of volunteers who report adverse events</measure>
    <time_frame>Up to 22 days following Day 1 of Treatment Period 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence Group AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence Group BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canagliflozin 300 mg</intervention_name>
    <description>Singe over-encapsulated 300 mg tablet of canagliflozin administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.</description>
    <arm_group_label>Treatment Sequence Group AB</arm_group_label>
    <arm_group_label>Treatment Sequence Group BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Singe capsule of placebo administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.</description>
    <arm_group_label>Treatment Sequence Group AB</arm_group_label>
    <arm_group_label>Treatment Sequence Group BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Somatostatin</intervention_name>
    <description>A primed (50 mcg in 1 mL sterile 0.9% NaCl solution i.v. injection over 1 minute) constant (500 mcg/hour) i.v. infusion of somatostatin for 4 hours approximately 2 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2. The total dose of somatostatin administered during each period will be 50 mcg + 500 mcg/hour x 4 hours = 2050 mcg.</description>
    <arm_group_label>Treatment Sequence Group AB</arm_group_label>
    <arm_group_label>Treatment Sequence Group BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>C-peptide</intervention_name>
    <description>Single bolus dose of 150 mcg synthetic human C-peptide in 1 mL water for injection administered i.v. (in the vein) approximately 3 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2.</description>
    <arm_group_label>Treatment Sequence Group AB</arm_group_label>
    <arm_group_label>Treatment Sequence Group BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers with a body mass index (BMI, a measure of a person's weight in&#xD;
             relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less&#xD;
             than 50 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of or current clinically significant medical illness as determined by the&#xD;
             Investigator&#xD;
&#xD;
          -  History of clinically significant allergies, especially known hypersensitivity or&#xD;
             intolerance to lactose&#xD;
&#xD;
          -  Known allergy or clinically significant adverse reactions to canagliflozin or placebo&#xD;
             or any of the excipients of the canagliflozin or placebo formulation&#xD;
&#xD;
          -  Known hypersensitivity of synthetic human C-peptide, somatostatin preparation, or&#xD;
             other structurally related peptides&#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-Cilag International NV Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen-Cilag International NV</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Neuss</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>June 6, 2013</last_update_submitted>
  <last_update_submitted_qc>June 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Clearance</keyword>
  <keyword>Canagliflozin</keyword>
  <keyword>JNJ-28431754</keyword>
  <keyword>Placebo</keyword>
  <keyword>Somatostatin</keyword>
  <keyword>C-peptide</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Canagliflozin</mesh_term>
    <mesh_term>Somatostatin</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/NCT01665638
org study id: CR100800
secondary id: 28431754DIA1049
secondary id: 2012-001667-73
nct id: NCT01665638
lead sponsor: 
has dmc: No
The purpose of this study is to assess whether treatment with a single oral 300 mg dose of
      canagliflozin alters the kinetics (ie, clearance/removal from body) of serum C-peptide (a
      protein released from the pancreas during insulin secretion) in healthy adult volunteers.
This is a double-blind (neither the volunteer nor the study doctor/staff will know the
      identity of the assigned treatments) study to assess the effect of single oral (taken by
      mouth) dose of canagliflozin on clearance (removal from the body) of C-peptide in healthy
      adult volunteers. Healthy volunteers will be randomly (by chance) assigned to receive a
      single oral dose of canagliflozin followed by a single oral dose of placebo (inactive
      substance) or a single dose of placebo followed by a single dose of canagliflozin with a
      period of 7-10 days between treatments. Healthy volunteers will also receive intravenous
      (i.v.) infusion (injection in the vein) of somatostatin for 4 hours and a single dose i.v.
      injection of synthetic human C-peptide following administration of canagliflozin or placebo
      during each treatment period. Somatostatin will suppress the normal secretion of C-peptide, a
      protein that is released from the pancreas during insulin secretion, so that the human
      C-peptide administered to volunteers can be accurately measured. The total study duration for
      each volunteer will be approximately 44 days. During the study, blood and urine samples will
      be drawn (collected) for clinical laboratory evaluations.
allocation: Randomized
intervention model: Crossover Assignment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from baseline in C-peptide kinetic parameters
time frame: Before and after study drug administration on Day 1 of Treatment Periods 1 and 2
description: Parameters are volume of distribution (Vd), clearance (CL) and half life (T1/2)
measure: The number of volunteers who report adverse events
time frame: Up to 22 days following Day 1 of Treatment Period 1
arm group label: Treatment Sequence Group AB
arm group type: Experimental
arm group label: Treatment Sequence Group BA
arm group type: Experimental
intervention type: Drug
intervention name: Canagliflozin 300 mg
description: Singe over-encapsulated 300 mg tablet of canagliflozin administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.
arm group label: Treatment Sequence Group AB
arm group label: Treatment Sequence Group BA
intervention type: Drug
intervention name: Placebo
description: Singe capsule of placebo administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.
arm group label: Treatment Sequence Group AB
arm group label: Treatment Sequence Group BA
intervention type: Drug
intervention name: Somatostatin
description: A primed (50 mcg in 1 mL sterile 0.9% NaCl solution i.v. injection over 1 minute) constant (500 mcg/hour) i.v. infusion of somatostatin for 4 hours approximately 2 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2. The total dose of somatostatin administered during each period will be 50 mcg + 500 mcg/hour x 4 hours = 2050 mcg.
arm group label: Treatment Sequence Group AB
arm group label: Treatment Sequence Group BA
intervention type: Drug
intervention name: C-peptide
description: Single bolus dose of 150 mcg synthetic human C-peptide in 1 mL water for injection administered i.v. (in the vein) approximately 3 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2.
arm group label: Treatment Sequence Group AB
arm group label: Treatment Sequence Group BA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen-Cilag International NV Clinical Trial
role: Study Director
affiliation: Janssen-Cilag International NV
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Canagliflozin
mesh term: Somatostatin