<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/NCT01678287</url>
  </required_header>
  <id_info>
    <org_study_id>1941-CL-0052</org_study_id>
    <nct_id>NCT01678287</nct_id>
  </id_info>
  <brief_title>Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy Adults</brief_title>
  <official_title>A Phase 1, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Pharmacokinetics, Safety and Tolerability of Repeat Oral Dosing of ASP1941 and to Explore the Effect of ASP1941 on Glucose Levels in Healthy Adult Subjects (18 to 45 Years and ≥ 65 Years)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, 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 is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after&#xD;
      repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy&#xD;
      adult male and female subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">January 2008</completion_date>
  <primary_completion_date type="Actual">January 2008</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>Parallel Assignment</intervention_model>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse events (AEs)</measure>
    <time_frame>Through Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as assessed by vital signs, electrocardiogram (ECG), physical examination, and laboratory evaluations</measure>
    <time_frame>Through Day 29</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic profile of ASP1941 (plasma):AUCtau, CL/F, Cmax, tmax, t1/2, Vz/F, PTR</measure>
    <time_frame>Days 1 and 18 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose</time_frame>
    <description>Area under the curve over the time interval between consecutive dosing (AUCtau),Apparent total body clearance after extravascular dosing (CL/F), Maximum observed concentration (Cmax), Time to reach Cmax (Tmax), Terminal elimination half-life (t1/2), Apparent volume of distribution during the terminal phase after single or repeated extravascular dosing (Vz/F), Peak Trough Ratio (PTR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic profile of ASP1941 (urine): Ae, Ae%, Aelast, Aelast%, Ae24, CLR</measure>
    <time_frame>Day 1 at pre-dose and from 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96 hours post-dose</time_frame>
    <description>Cumulative amount of drug excreted into urine up to the ending time of the last collection period (Ae), Fraction of the drug excreted in urine (Ae) in % up to the ending time of last collection period (Ae%), Cumulative amount of drug or glucose excreted into urine up to the collection time of the last measurable amount (Aelast),Fraction of drug excreted into urine (Ae) in % up to the collection time of the last measurable concentration (Aelast% ), Fraction of glucose excreted into urine up to 24 hrs (Ae24), Renal clearance (CLR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic profile of ASP1941 (urine): Aetau, Aetau%, Aelast, CLR</measure>
    <time_frame>Day 18 at pre-dose and from 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96 hours post-dose</time_frame>
    <description>Cumulative amount of drug or glucose excreted into urine over the time interval between consecutive dosing (Aetau ), Fraction of drug or glucose excreted into urine (Aetau) in % over the time interval between consecutive dosing (Aetau%)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic profile of blood glucose: Cmax and AUCtau</measure>
    <time_frame>Day -1 at -24, -23.75, -23.5, -23, -22.5, -22, -21, -20, -18, -16, -12, -8 and 0 (predose) hours prior to dose on Day 1 and on Day 18 predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic profile of urine glucose: Aelast and Aetau</measure>
    <time_frame>Day 1 and Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of glucose excretion per sampling interval</measure>
    <time_frame>Day 1 and Day 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of glucose excretion over 24 hours</measure>
    <time_frame>Day 1 and Day 18</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Healthy Volunteers</condition>
  <condition>Pharmacokinetics of ASP1941</condition>
  <arm_group>
    <arm_group_label>Arm 1 Non elderly receiving ASP1941</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>healthy subjects age 18 to 45 years receiving ASP1941</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 Non elderly receiving placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>healthy subjects age 18 to 45 years receiving placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3 Elderly receiving ASP1941</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>healthy subjects age ≥ 65 years receiving ASP1941</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4 Elderly receiving placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>healthy subjects age ≥ 65 years receiving placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP1941</intervention_name>
    <description>oral</description>
    <arm_group_label>Arm 1 Non elderly receiving ASP1941</arm_group_label>
    <arm_group_label>Arm 3 Elderly receiving ASP1941</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral</description>
    <arm_group_label>Arm 2 Non elderly receiving placebo</arm_group_label>
    <arm_group_label>Arm 4 Elderly receiving placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, healthy non-elderly (age 18-45 years, inclusive) or healthy elderly&#xD;
             (age 65 or over)&#xD;
&#xD;
          -  If female, subject is not pregnant or nursing, and uses medically acceptable&#xD;
             contraceptive method to prevent pregnancy from screening until study discharge&#xD;
&#xD;
          -  Body weigh between 60 and 100kg and body Mass Index between 20 and 30kg/m2, inclusive&#xD;
&#xD;
          -  Negative urine screen for drugs of abuse, including alcohol and cotinine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of type 1 or type 2 diabetes&#xD;
&#xD;
          -  Fasting plasma glucose level higher than 6.4mmol/L or hemoglobin A1c level higher than&#xD;
             6.2%&#xD;
&#xD;
          -  Presence of renal glucosuria and/or proteinuria&#xD;
&#xD;
          -  Clinically significant history of asthma, eczema, and or any other allergic condition.&#xD;
&#xD;
          -  Clinically significant history of upper gastrointestinal symptoms within the 4 weeks&#xD;
             prior to admission to the clinical unit.&#xD;
&#xD;
          -  History of any clinically significant neurological, gastrointestinal, renal, hepatic,&#xD;
             pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder&#xD;
             or disease, or any other medical condition that would preclude participation in the&#xD;
             study.&#xD;
&#xD;
          -  History of multiple drug allergies or a known allergy or suspected hypersensitivity to&#xD;
             the study drug or any chemically related derivatives of the study drug or any&#xD;
             components of the formulation&#xD;
&#xD;
          -  Has hepatitis or a positive result to serology test for hepatitis A antibody&#xD;
             Immunoglobulin M, hepatitis B surface antigen or hepatitis C virus at screening&#xD;
&#xD;
          -  Known to be positive for human immunodeficiency virus antibodies.&#xD;
&#xD;
          -  Donated one unit (450 mL) or more of blood or plasma within 60 days prior to the first&#xD;
             dose of study medication.&#xD;
&#xD;
          -  Has a history of consuming more than an average of 2 ounces of alcohol-containing&#xD;
             products per day or a history of alcoholism or drug/chemical abuse within the last 3&#xD;
             years.&#xD;
&#xD;
          -  Use of any tobacco or nicotine-containing products within 120 days prior to the first&#xD;
             dose of study medication.&#xD;
&#xD;
          -  Taken any prescribed systemic or topical medication within 21 days prior to the first&#xD;
             dose of study medication with the exception of contraceptives to prevent pregnancy.&#xD;
&#xD;
          -  Taken any systemic or topical over-the counter medication, complementary or&#xD;
             alternative medications, e.g., vitamins, herbal, or nutritional supplements, with the&#xD;
             exception of acetaminophen, within 10 days prior to the first dose of study&#xD;
             medication.&#xD;
&#xD;
          -  Taken an investigational drug within 30 days of the first dose of study medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Phase One</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>August 30, 2012</last_update_submitted>
  <last_update_submitted_qc>August 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASP1941</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/NCT01678287
org study id: 1941-CL-0052
nct id: NCT01678287
lead sponsor: 
has dmc: No
This is a study of the pharmacokinetic profile and safety and tolerability of ASP1941after
      repeat dosing and the effect of ASP1941 on glucose levels in non elderly and elderly healthy
      adult male and female subjects.
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of adverse events (AEs)
time frame: Through Day 29
measure: Safety as assessed by vital signs, electrocardiogram (ECG), physical examination, and laboratory evaluations
time frame: Through Day 29
measure: Pharmacokinetic profile of ASP1941 (plasma):AUCtau, CL/F, Cmax, tmax, t1/2, Vz/F, PTR
time frame: Days 1 and 18 pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose
description: Area under the curve over the time interval between consecutive dosing (AUCtau),Apparent total body clearance after extravascular dosing (CL/F), Maximum observed concentration (Cmax), Time to reach Cmax (Tmax), Terminal elimination half-life (t1/2), Apparent volume of distribution during the terminal phase after single or repeated extravascular dosing (Vz/F), Peak Trough Ratio (PTR)
measure: Pharmacokinetic profile of ASP1941 (urine): Ae, Ae%, Aelast, Aelast%, Ae24, CLR
time frame: Day 1 at pre-dose and from 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96 hours post-dose
description: Cumulative amount of drug excreted into urine up to the ending time of the last collection period (Ae), Fraction of the drug excreted in urine (Ae) in % up to the ending time of last collection period (Ae%), Cumulative amount of drug or glucose excreted into urine up to the collection time of the last measurable amount (Aelast),Fraction of drug excreted into urine (Ae) in % up to the collection time of the last measurable concentration (Aelast% ), Fraction of glucose excreted into urine up to 24 hrs (Ae24), Renal clearance (CLR)
measure: Pharmacokinetic profile of ASP1941 (urine): Aetau, Aetau%, Aelast, CLR
time frame: Day 18 at pre-dose and from 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96 hours post-dose
description: Cumulative amount of drug or glucose excreted into urine over the time interval between consecutive dosing (Aetau ), Fraction of drug or glucose excreted into urine (Aetau) in % over the time interval between consecutive dosing (Aetau%)
measure: Pharmacodynamic profile of blood glucose: Cmax and AUCtau
time frame: Day -1 at -24, -23.75, -23.5, -23, -22.5, -22, -21, -20, -18, -16, -12, -8 and 0 (predose) hours prior to dose on Day 1 and on Day 18 predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose
measure: Pharmacodynamic profile of urine glucose: Aelast and Aetau
time frame: Day 1 and Day 18
measure: Rate of glucose excretion per sampling interval
time frame: Day 1 and Day 18
measure: Rate of glucose excretion over 24 hours
time frame: Day 1 and Day 18
arm group label: Arm 1 Non elderly receiving ASP1941
arm group type: Experimental
description: healthy subjects age 18 to 45 years receiving ASP1941
arm group label: Arm 2 Non elderly receiving placebo
arm group type: Experimental
description: healthy subjects age 18 to 45 years receiving placebo
arm group label: Arm 3 Elderly receiving ASP1941
arm group type: Experimental
description: healthy subjects age ≥ 65 years receiving ASP1941
arm group label: Arm 4 Elderly receiving placebo
arm group type: Experimental
description: healthy subjects age ≥ 65 years receiving placebo
intervention type: Drug
intervention name: ASP1941
description: oral
arm group label: Arm 1 Non elderly receiving ASP1941
arm group label: Arm 3 Elderly receiving ASP1941
intervention type: Drug
intervention name: Placebo
description: oral
arm group label: Arm 2 Non elderly receiving placebo
arm group label: Arm 4 Elderly receiving placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ipragliflozin