<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/NCT01666327</url>
  </required_header>
  <id_info>
    <org_study_id>MT-1303-E03</org_study_id>
    <nct_id>NCT01666327</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease</brief_title>
  <official_title>An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma Corporation</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and&#xD;
      pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, non-randomised, single-dose study to evaluate the safety,&#xD;
      tolerability, pharmacokinetics and pharmacodynamics of MT-1303 in subjects with inflammatory&#xD;
      bowel disease (Crohn's Disease and Ulcerative Colitis).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events</measure>
    <time_frame>1month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak plasma concentration (Cmax) of MT-1303 and its metabolite</measure>
    <time_frame>15 time points up to 1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite</measure>
    <time_frame>15 time points up to 1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic effect of MT-1303 on lymphocyte count</measure>
    <time_frame>16 time points up to 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory parameter : C-reactive protein (CRP)</measure>
    <time_frame>4 time points up to 1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory parameter :Erythrocyte sedimentation (ESR)</measure>
    <time_frame>4 time points up to 1 week</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>MT-1303</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-1303</intervention_name>
    <arm_group_label>MT-1303</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A body mass index (BMI) ranging from 16 to 34 kg/m2&#xD;
&#xD;
          -  Subjects who were diagnosed as Crohn's Disease or Ulcerative Colitis at least 6 months&#xD;
             prior to Screening, clinically confirmed either by radiological, endoscopic or&#xD;
             histological examination.&#xD;
&#xD;
          -  Subjects who have had at least one flare within 18 months prior to Screening.&#xD;
&#xD;
          -  Confirmed medical records of inflammatory lesions in intestinal tract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Present or past history of clinically significant gastrointestinal surgery.&#xD;
&#xD;
          -  Present or past history of clinically significant stenosis, stricture or fistula in&#xD;
             small intestine or colon.&#xD;
&#xD;
          -  Known hypersensitivity to any formulation excipients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's Disease</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_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/NCT01666327
org study id: MT-1303-E03
nct id: NCT01666327
lead sponsor: 
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel
      disease.
This is an open-label, non-randomised, single-dose study to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of MT-1303 in subjects with inflammatory
      bowel disease (Crohn's Disease and Ulcerative Colitis).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
time frame: 1month
measure: Peak plasma concentration (Cmax) of MT-1303 and its metabolite
time frame: 15 time points up to 1 month
measure: Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
time frame: 15 time points up to 1 month
measure: Pharmacodynamic effect of MT-1303 on lymphocyte count
time frame: 16 time points up to 1 month
measure: Exploratory parameter : C-reactive protein (CRP)
time frame: 4 time points up to 1 week
measure: Exploratory parameter :Erythrocyte sedimentation (ESR)
time frame: 4 time points up to 1 week
arm group label: MT-1303
arm group type: Experimental
intervention type: Drug
intervention name: MT-1303
arm group label: MT-1303
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases