<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/NCT01674777</url>
  </required_header>
  <id_info>
    <org_study_id>1941-CL-0071</org_study_id>
    <nct_id>NCT01674777</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Effect of Food on the Absorption, Distribution and Elimination of ASP1941</brief_title>
  <official_title>A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of ASP1941</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics&#xD;
      and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a randomized, open-label, 3-way crossover design study to investigate the effect&#xD;
      of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after&#xD;
      administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will&#xD;
      receive a single dose of ASP1941 &quot;under fasting condition&quot;, &quot;before meal&quot; and &quot;after meal&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">December 2010</completion_date>
  <primary_completion_date type="Actual">December 2010</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax</measure>
    <time_frame>For 72 hours after each administration</time_frame>
    <description>Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance</measure>
    <time_frame>For 72 hours after each administration</time_frame>
    <description>Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests</measure>
    <time_frame>For 72 hours after each administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in urinary glucose excretion</measure>
    <time_frame>Before and for 72 hours after each administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <condition>Pharmacokinetics of ASP1941</condition>
  <arm_group>
    <arm_group_label>under fasting condition group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a single dose of ASP1941 under fasting condition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>before meal group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a single dose of ASP1941 before meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>after meal condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a single dose of ASP1941 after meal</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP1941</intervention_name>
    <description>oral</description>
    <arm_group_label>after meal condition</arm_group_label>
    <arm_group_label>before meal group</arm_group_label>
    <arm_group_label>under fasting condition group</arm_group_label>
    <other_name>ipragliflozin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy as judged by the investigator/subinvestigator based on the results of physical&#xD;
             examinations and laboratory tests&#xD;
&#xD;
          -  Body weight ; ≥50.0 kg, &lt;80.0 kg&#xD;
&#xD;
          -  Body Mass Index ; ≥17.6, &lt;26.4&#xD;
&#xD;
          -  Written informed consent has been obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received any investigational drugs within 120 days before the screening assessment&#xD;
&#xD;
          -  Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or&#xD;
             d components within 14 days before the screening assessment&#xD;
&#xD;
          -  Received medication within 7 days before hospital admission&#xD;
&#xD;
          -  A deviation from the assessment criteria of physical examinations or laboratory tests&#xD;
             at screening or upon admission&#xD;
&#xD;
          -  History of drug allergies&#xD;
&#xD;
          -  With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Use Central Contact</last_name>
    <role>Study Chair</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Kantou</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASP1941</keyword>
  <keyword>Food effect</keyword>
  <keyword>Pharmacokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ipragliflozin</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/NCT01674777
org study id: 1941-CL-0071
nct id: NCT01674777
lead sponsor: 
has dmc: No
This study is to investigate the effect of food on the pharmacokinetics, the pharmacodynamics
      and safety of ASP1941 after administration of ASP1941 in healthy non-elderly adult male
      subjects.
This will be a randomized, open-label, 3-way crossover design study to investigate the effect
      of food on the pharmacokinetics, the pharmacodynamics and safety of ASP1941 after
      administration of ASP1941 in healthy non-elderly adult male subjects. Each subject will
      receive a single dose of ASP1941 "under fasting condition", "before meal" and "after meal".
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Pharmacokinetics (PK) profiles of ASP1941 (in plasma): AUCinf, AUClast and Cmax
time frame: For 72 hours after each administration
description: Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)
measure: Pharmacokinetics (PK) profiles of ASP1941 (in plasma): tmax, t1/2, apparent distribution volume, apparent body clearance
time frame: For 72 hours after each administration
description: Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 )
measure: Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests
time frame: For 72 hours after each administration
measure: Changes in urinary glucose excretion
time frame: Before and for 72 hours after each administration
arm group label: under fasting condition group
arm group type: Experimental
description: Subjects will receive a single dose of ASP1941 under fasting condition
arm group label: before meal group
arm group type: Experimental
description: Subjects will receive a single dose of ASP1941 before meal
arm group label: after meal condition
arm group type: Experimental
description: Subjects will receive a single dose of ASP1941 after meal
intervention type: Drug
intervention name: ASP1941
description: oral
arm group label: after meal condition
arm group label: before meal group
arm group label: under fasting condition group
other name: ipragliflozin
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Use Central Contact
role: Study Chair
affiliation: Astellas Pharma Inc
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Ipragliflozin