<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/NCT03011931</url>
  </required_header>
  <id_info>
    <org_study_id>15-007568</org_study_id>
    <nct_id>NCT03011931</nct_id>
  </id_info>
  <brief_title>Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]</brief_title>
  <official_title>Simvastatin Metabolism as a Test for Celiac Disease Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immunogenics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Immunogenics, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the correlation between simvastatin metabolism by the enterocyte and the histologic&#xD;
      state of the intestine in treated celiac disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cross sectional design incorporating subjects with active celiac disease and healed celiac&#xD;
      disease (based on clinically-obtained biopsies); and healthy individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare simvastatin metabolism with intestinal biopsies</measure>
    <time_frame>Within one month of visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Villous height and crypt depth</measure>
    <time_frame>Within 1 month of visit</time_frame>
    <description>As measured in intestinal biopsies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary interview</measure>
    <time_frame>At initial visit</time_frame>
    <description>To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinalysis</measure>
    <time_frame>Prior to administration of simvastatin and at the 3-hour mark</time_frame>
    <description>Looking for traces of gluten peptides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serologic testing</measure>
    <time_frame>Prior to administration of simvastatin</time_frame>
    <description>tTG IgA titer level determination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DNA sampling</measure>
    <time_frame>Prior to administration of simvastatin</time_frame>
    <description>Genetic testing associated with celiac disease (DQ2 and DQ8)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Celiac Disease</condition>
  <arm_group>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Simvastatin tablet, 20 mg, one time by mouth</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin</intervention_name>
    <description>20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <other_name>Zocor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gluten-free diet for at least 1 year&#xD;
&#xD;
          2. Clinical endoscopy within the past month&#xD;
&#xD;
          3. Biopsies must show no villous atrophy or villous blunting&#xD;
&#xD;
          4. Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. 1st degree relative with Celiac Disease&#xD;
&#xD;
          2. Positive tTG IgA, already on simvastatin or statin agent&#xD;
&#xD;
          3. Unable to stop non-steroidal or anti-inflammatory drugs&#xD;
&#xD;
          4. Prior history of GI surgery other than appendectomy or cholecystectomy&#xD;
&#xD;
          5. Taking drugs know to inhibit or activate CYP3A4&#xD;
&#xD;
          6. Unable to avoid food known to inhibit CYP3A4&#xD;
&#xD;
          7. History of a reaction to statin drugs in the past&#xD;
&#xD;
          8. Pregnant or nursing women&#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>Joseph A Murray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 3, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simvastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03011931
org study id: 15-007568
nct id: NCT03011931
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To study the correlation between simvastatin metabolism by the enterocyte and the histologic
      state of the intestine in treated celiac disease.
A cross sectional design incorporating subjects with active celiac disease and healed celiac
      disease (based on clinically-obtained biopsies); and healthy individuals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Compare simvastatin metabolism with intestinal biopsies
time frame: Within one month of visit
measure: Villous height and crypt depth
time frame: Within 1 month of visit
description: As measured in intestinal biopsies
measure: Dietary interview
time frame: At initial visit
description: To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet
measure: Urinalysis
time frame: Prior to administration of simvastatin and at the 3-hour mark
description: Looking for traces of gluten peptides
measure: Serologic testing
time frame: Prior to administration of simvastatin
description: tTG IgA titer level determination
measure: DNA sampling
time frame: Prior to administration of simvastatin
description: Genetic testing associated with celiac disease (DQ2 and DQ8)
arm group label: Simvastatin
arm group type: Experimental
description: Simvastatin tablet, 20 mg, one time by mouth
intervention type: Drug
intervention name: Simvastatin
description: 20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review
arm group label: Simvastatin
other name: Zocor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph A Murray, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor
mesh term: Celiac Disease
mesh term: Simvastatin
sharing ipd: No