<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/NCT01716338</url>
  </required_header>
  <id_info>
    <org_study_id>A-15112.b</org_study_id>
    <nct_id>NCT01716338</nct_id>
    <nct_alias>NCT01157637</nct_alias>
  </id_info>
  <brief_title>Glyburide Healthy Volunteer Study</brief_title>
  <official_title>Glyburide Healthy Volunteer Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Maryland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glyburide is a medication that has been safely used for several decades to treat non-insulin&#xD;
      dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the&#xD;
      lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and&#xD;
      cognitively. The investigators are hopeful that the results of this study will provide the&#xD;
      necessary foundation to evaluate this medication's use on a larger scale to determine the&#xD;
      feasibility of using glyburide in soldiers either prophylactically or for the treatment of&#xD;
      brain injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a placebo controlled (2:1 drug vs. placebo), randomized clinical trial of 21&#xD;
      healthy, non-diabetic volunteers receiving daily doses of oral glyburide (1.5 mg) vs. placebo&#xD;
      while under careful medical monitoring in an inpatient Clinical Research Unit (CRU)within the&#xD;
      Center for Applied Research Sciences (CARS) at the Washington University in St. Louis Medical&#xD;
      Center for a duration of 7 days and nights (24 hours per day). Interested subjects who call&#xD;
      for more information about the study will be scheduled for a screening visit. Subjects will&#xD;
      participate first in an informed consent process, and those wishing to take part will be&#xD;
      asked to undergo a comprehensive interview detailing their past medical history and formal&#xD;
      physical examination (which includes laboratory tests of the urine and blood). If a subject&#xD;
      is deemed appropriate by the team, he/she will be asked to perform an exercise test&#xD;
      (treadmill for 30 minutes) and will have an Electrocardiogram (ECG) completed to further&#xD;
      determine eligibility. Individuals who do not meet inclusion criteria based on screening&#xD;
      activities will be notified immediately that they are not eligible. Volunteers meeting all&#xD;
      eligibility criteria will be scheduled for the week long in-patient evaluation.&#xD;
&#xD;
      Each subject will undergo a battery of physical, cognitive, and laboratory tests in addition&#xD;
      to receiving oral glyburide or placebo each day for one week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>7 days</time_frame>
    <description>The primary objective of this study is to evaluate the safety of glyburide in healthy, non-diabetic volunteers while simulating strenuous activity to observe for any adverse events (i.e. hypoglycemia, dizziness, confusion, etc.). Neuropsychological testing, physical exams, vital signs, ECGs, cognitive assessments, and laboratory values (including serum glucose levels collected 4 x's per day and as needed) will be conducted throughout the 7 day in-patient study to assess for any adverse/serious adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive impact</measure>
    <time_frame>7 days</time_frame>
    <description>Determine the impact after 7 days of glyburide 1.5mg daily (with breakfast) in healthy volunteers who are able to participate in scheduled strenuous activities and adhere to a structured meal plan on cognitive performance using a computer program to test cognition before study drug administration and at the end of the study in addition to daily physical examinations which include mini mental status exams.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Glyburide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1.5 mg (lowest dose) by mouth every day with breakfast for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar Pill (Capsule)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo capsule by mouth every day with breakfast for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glyburide</intervention_name>
    <arm_group_label>Glyburide</arm_group_label>
    <other_name>Micronase</other_name>
    <other_name>Glybencamide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Sugar Pill (Capsule)</arm_group_label>
    <other_name>Sugar Pill (capsule)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers between the ages of 18 and 40.&#xD;
&#xD;
          -  Have a Body Mass Index (BMI) between 18-30.&#xD;
&#xD;
          -  Normal screening physical examination (non-pregnant as confirmed by serum Beta&#xD;
             HcG,non-diabetic as confirmed by normal Hgb A-1C, normal baseline ECG and vital signs,&#xD;
             laboratory values within normal limits (the lab tests include: complete blood count,&#xD;
             electrolytes, liver function tests, kidney function tests, uric acid, cholesterol,&#xD;
             iron, urinalysis, urine drug screen; all are conducted within 2 weeks prior to&#xD;
             randomization).&#xD;
&#xD;
          -  Women of Childbearing Potential (WCP) demonstrate a willingness to use contraception&#xD;
             methods (other than birth control medications) to prevent pregnancy from time of&#xD;
             consent to 30 days past last dose. **Note, birth control medications MAY BE used after&#xD;
             completion of the inpatient hospital phase of the study (i.e. after discharge).&#xD;
&#xD;
          -  Unremarkable past medical history.&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
&#xD;
          -  Ability to undergo physical exercise (determined through a treadmill exercise test to&#xD;
             ensure physical fitness of participants). Those who experience fatigue, dizziness or&#xD;
             chest pain during the screening exercise test on the treadmill will be excluded.&#xD;
&#xD;
          -  Ability to undergo neuropsychological test for attention, cognition, dexterity, etc.&#xD;
&#xD;
          -  Willing to remain in the in-patient setting for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of investigational drug within 4 weeks of study.&#xD;
&#xD;
          -  Using tobacco.&#xD;
&#xD;
          -  Acute illness or surgery within 4 weeks of study.&#xD;
&#xD;
          -  Allergic to sulfonylurea-related drugs.&#xD;
&#xD;
          -  Presence of pathological condition of any part of the body.&#xD;
&#xD;
          -  Any medication within 2 weeks of the study, including oral contraceptives.&#xD;
&#xD;
          -  Ingestion of alcohol or caffeine containing food or beverages within 48 hours of start&#xD;
             of study.&#xD;
&#xD;
          -  History of alcohol or drug abuse, cardiac arrhythmias, psychotropic agent use,&#xD;
             immunosuppressive condition (i.e. HIV, AIDS, Cancer) or hepatitis.&#xD;
&#xD;
          -  Donation of blood within 3 months or receiving blood products within 14 days.&#xD;
&#xD;
          -  Recent body tattoo or piercing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grant Bochicchio, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University in St. Louis Clinical Research Unit (CRU)</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glyburide</keyword>
  <keyword>glybenclamide</keyword>
  <keyword>hypoglycemia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glyburide</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/NCT01716338
org study id: A-15112.b
nct id: NCT01716338
nct alias: NCT01157637
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Glyburide is a medication that has been safely used for several decades to treat non-insulin
      dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the
      lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and
      cognitively. The investigators are hopeful that the results of this study will provide the
      necessary foundation to evaluate this medication's use on a larger scale to determine the
      feasibility of using glyburide in soldiers either prophylactically or for the treatment of
      brain injury.
This study is a placebo controlled (2:1 drug vs. placebo), randomized clinical trial of 21
      healthy, non-diabetic volunteers receiving daily doses of oral glyburide (1.5 mg) vs. placebo
      while under careful medical monitoring in an inpatient Clinical Research Unit (CRU)within the
      Center for Applied Research Sciences (CARS) at the Washington University in St. Louis Medical
      Center for a duration of 7 days and nights (24 hours per day). Interested subjects who call
      for more information about the study will be scheduled for a screening visit. Subjects will
      participate first in an informed consent process, and those wishing to take part will be
      asked to undergo a comprehensive interview detailing their past medical history and formal
      physical examination (which includes laboratory tests of the urine and blood). If a subject
      is deemed appropriate by the team, he/she will be asked to perform an exercise test
      (treadmill for 30 minutes) and will have an Electrocardiogram (ECG) completed to further
      determine eligibility. Individuals who do not meet inclusion criteria based on screening
      activities will be notified immediately that they are not eligible. Volunteers meeting all
      eligibility criteria will be scheduled for the week long in-patient evaluation.

      Each subject will undergo a battery of physical, cognitive, and laboratory tests in addition
      to receiving oral glyburide or placebo each day for one week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants with Adverse Events
time frame: 7 days
description: The primary objective of this study is to evaluate the safety of glyburide in healthy, non-diabetic volunteers while simulating strenuous activity to observe for any adverse events (i.e. hypoglycemia, dizziness, confusion, etc.). Neuropsychological testing, physical exams, vital signs, ECGs, cognitive assessments, and laboratory values (including serum glucose levels collected 4 x's per day and as needed) will be conducted throughout the 7 day in-patient study to assess for any adverse/serious adverse events.
measure: Cognitive impact
time frame: 7 days
description: Determine the impact after 7 days of glyburide 1.5mg daily (with breakfast) in healthy volunteers who are able to participate in scheduled strenuous activities and adhere to a structured meal plan on cognitive performance using a computer program to test cognition before study drug administration and at the end of the study in addition to daily physical examinations which include mini mental status exams.
arm group label: Glyburide
arm group type: Active Comparator
description: 1.5 mg (lowest dose) by mouth every day with breakfast for 7 days
arm group label: Sugar Pill (Capsule)
arm group type: Placebo Comparator
description: Matching placebo capsule by mouth every day with breakfast for 7 days
intervention type: Drug
intervention name: Glyburide
arm group label: Glyburide
other name: Micronase
other name: Glybencamide
intervention type: Drug
intervention name: Placebo
arm group label: Sugar Pill (Capsule)
other name: Sugar Pill (capsule)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Grant Bochicchio, MD, MPH
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glyburide