<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/NCT02187094</url>
  </required_header>
  <id_info>
    <org_study_id>TC-6499-12-CLP-005</org_study_id>
    <nct_id>NCT02187094</nct_id>
  </id_info>
  <brief_title>Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Targacept Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Targacept Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic&#xD;
      disorder that slows or stops the passage of food from the stomach to the small intestine. The&#xD;
      purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric&#xD;
      emptying time in diabetic subjects with gastroparesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in&#xD;
      diabetic subjects with gastroparesis. The length of study participation for a subject is up&#xD;
      to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath&#xD;
      test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period,&#xD;
      subjects will complete 4 overnight drug assessment visits (treatment arms) where they will&#xD;
      receive a randomized single dose of study drug and the GEBT. Each overnight visit will be&#xD;
      separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4&#xD;
      dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.</measure>
    <time_frame>4 hrs post-GEBT meal</time_frame>
    <description>Gastric emptying time will be assessed using the oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT) administered following each treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percent dose excreted as 13-CO2 at specific post-meal time points for each treatment relative to placebo after single dose administration of study drug in each arm.</measure>
    <time_frame>90 and 120 min post-GEBT meal</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time of maximal rate of 13-CO2 expiration for each treatment relative to placebo after single dose administration of study drug in each arm.</measure>
    <time_frame>4 hrs post-GEBT meal</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One capsule of placebo administered as a single dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 mg TC-6499</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One capsule of 2 mg TC-6499 administered as a single dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 mg TC-6499</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One capsule of 5 mg TC-6499 administered as a single dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mg TC-6499</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One capsule of 10 mg TC-6499 administered as a single dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TC-6499</intervention_name>
    <arm_group_label>10 mg TC-6499</arm_group_label>
    <arm_group_label>2 mg TC-6499</arm_group_label>
    <arm_group_label>5 mg TC-6499</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6&#xD;
             months (and Gastroparesis Cardinal Symptoms Index total score &gt;22)&#xD;
&#xD;
          -  Gastroparesis confirmed using the GEBT&#xD;
&#xD;
          -  Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10%&#xD;
&#xD;
          -  Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT&#xD;
&#xD;
          -  Body Mass Index (BMI) ≤ 40&#xD;
&#xD;
          -  Willingness to remain in clinical research facility for the protocol-required days of&#xD;
             treatment and study procedures&#xD;
&#xD;
          -  Willingness to use a double barrier method of birth control (except post-menopausal&#xD;
             females)&#xD;
&#xD;
          -  Able to understand study procedures and provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of abdominal surgery including gastric banding procedure&#xD;
&#xD;
          -  Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube&#xD;
&#xD;
          -  Persistent daily vomiting&#xD;
&#xD;
          -  A history of eating disorder&#xD;
&#xD;
          -  Recent history of poor control of diabetes&#xD;
&#xD;
          -  Acute severe gastroenteritis&#xD;
&#xD;
          -  Have implanted or use any type of gastric electric stimulator&#xD;
&#xD;
          -  Use of opiates, anticholinergic medications, GLP-1 mimetics or amylin analogs&#xD;
&#xD;
          -  Use of medications potentially influencing upper gastrointestinal motility or appetite&#xD;
&#xD;
          -  Allergies or intolerance to egg, wheat, milk, or algae&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Presence of a clinically significant medical condition at any time during the study&#xD;
&#xD;
          -  Presence of clinically significant abnormalities in laboratory findings, physical exam&#xD;
             findings or vital signs&#xD;
&#xD;
          -  Participated in an investigational drug study within 30 days of screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Horizon Research Group, Inc.</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prefered Research Partners, Inc.</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Profil Institute for Clinical Research, Inc.</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ventura Clinical Trials</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinSearch, LLC</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Medical Research</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspen Clinical Research, LLC</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>May 11, 2015</last_update_submitted>
  <last_update_submitted_qc>May 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</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>Gastroparesis</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/NCT02187094
org study id: TC-6499-12-CLP-005
nct id: NCT02187094
lead sponsor: 
has dmc: No
Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic
      disorder that slows or stops the passage of food from the stomach to the small intestine. The
      purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric
      emptying time in diabetic subjects with gastroparesis.
This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in
      diabetic subjects with gastroparesis. The length of study participation for a subject is up
      to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath
      test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period,
      subjects will complete 4 overnight drug assessment visits (treatment arms) where they will
      receive a randomized single dose of study drug and the GEBT. Each overnight visit will be
      separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4
      dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.
time frame: 4 hrs post-GEBT meal
description: Gastric emptying time will be assessed using the oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT) administered following each treatment.
measure: The percent dose excreted as 13-CO2 at specific post-meal time points for each treatment relative to placebo after single dose administration of study drug in each arm.
time frame: 90 and 120 min post-GEBT meal
measure: The time of maximal rate of 13-CO2 expiration for each treatment relative to placebo after single dose administration of study drug in each arm.
time frame: 4 hrs post-GEBT meal
arm group label: Placebo
arm group type: Placebo Comparator
description: One capsule of placebo administered as a single dose.
arm group label: 2 mg TC-6499
arm group type: Experimental
description: One capsule of 2 mg TC-6499 administered as a single dose.
arm group label: 5 mg TC-6499
arm group type: Experimental
description: One capsule of 5 mg TC-6499 administered as a single dose.
arm group label: 10 mg TC-6499
arm group type: Experimental
description: One capsule of 10 mg TC-6499 administered as a single dose.
intervention type: Drug
intervention name: TC-6499
arm group label: 10 mg TC-6499
arm group label: 2 mg TC-6499
arm group label: 5 mg TC-6499
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gastroparesis