<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/NCT02989467</url>
  </required_header>
  <id_info>
    <org_study_id>16-007929</org_study_id>
    <nct_id>NCT02989467</nct_id>
  </id_info>
  <brief_title>Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying</brief_title>
  <official_title>A Single-Center, Placebo-Controlled, Double-Blind Study to Evaluate the Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is being done to compare the effects of Aprepitant and placebo on fasting&#xD;
      gastric volume, accommodation volume, satiation (fullness) and gastric emptying.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2017</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>Gastric Emptying Half-Time of Solids as Measured by Scintigraphy</measure>
    <time_frame>Day 3, approximately 2 hours after radiolabeled meal is ingested</time_frame>
    <description>The time for half of the ingested solids to leave the stomach.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satiation Expressed as Volume to Fullness</measure>
    <time_frame>Day 4, approximately 30 minutes after liquid meal</time_frame>
    <description>Subjects will do a satiation/nutrient drink test, consuming Ensure at a relatively constant rate of 30 ml/min. Subjects will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)</measure>
    <time_frame>Day 5, approximately 15 minutes after radioactive marker is administered</time_frame>
    <description>Subjects will arrive to the Clinical Research and Trials Unit (CRTU) fasting. A radioactive marker will be administered intravenously. After a 10-15 minute wait period a fasting scan will be acquired using a dual-head gamma camera.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postprandial Gastric Volume as Measured by SPECT</measure>
    <time_frame>Day 5, approximately 30 minutes after liquid meal</time_frame>
    <description>At the completion of the fasting scan, the subject will consume 300 ml of Ensure followed by a postprandial scan using a dual-head gamma camera.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accommodation Volume as Measured by SPECT</measure>
    <time_frame>Day 5, approximately 30 minutes after liquid meal</time_frame>
    <description>This variable is calculated as postprandial gastric volume minus fasting volume.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours</measure>
    <time_frame>Day 3, approximately 2 hours after radiolabeled meal is ingested</time_frame>
    <description>On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours</measure>
    <time_frame>Day 3, approximately 4 hours after radiolabeled meal is ingested</time_frame>
    <description>On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 4 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Tolerated Volume on Satiation Test</measure>
    <time_frame>Day 4, approximately 30 minutes after liquid meal</time_frame>
    <description>On Day 4, subjects will do a satiation/nutrient drink test. Participants will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test</measure>
    <time_frame>Day 4, approximately 30 minutes after liquid meal</time_frame>
    <description>Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words &quot;none&quot; and &quot;worst ever&quot; anchored at each end.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aggregate Symptoms Score</measure>
    <time_frame>Day 4, approximately 1 hour after liquid meal</time_frame>
    <description>Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words &quot;none&quot; and &quot;worst ever&quot; anchored at each end. The aggregate symptoms score is calculated by adding the mean individual scores. The lowest possible score would be 0 (none) and the highest maximum score possible is 400 (worst ever).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric Volume Ratio</measure>
    <time_frame>Day 5, approximately 1 hour after radioactive marker is administered</time_frame>
    <description>Postprandial/fasting gastric volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute postprandial gastric volume</measure>
    <time_frame>Day 5, approximately 1 hour after radioactive marker is administered</time_frame>
    <description>This is the total postprandial gastric volume</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Aprepitant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive one placebo tablet daily for 5 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aprepitant</intervention_name>
    <description>Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.</description>
    <arm_group_label>Aprepitant</arm_group_label>
    <other_name>Emend</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive one placebo tablet daily for 5 consecutive days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Able to provide written consent&#xD;
&#xD;
          2. No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus&#xD;
&#xD;
          3. Body Mass Index of 18-35 kg/m^2&#xD;
&#xD;
          4. Female subjects must have negative urine pregnancy tests and must not be lactating&#xD;
             prior to receiving study medication and radiation exposure&#xD;
&#xD;
          5. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable)&#xD;
             and single-barrier method, or a double-barrier method of birth control must be used&#xD;
             throughout the study&#xD;
&#xD;
          6. Female subjects unable to bear children must have this documented in the medical&#xD;
             record (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum&#xD;
             of one year since the last menstrual period])&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Diagnosis of gastrointestinal diseases&#xD;
&#xD;
          2. Structural or metabolic diseases that affect the gastrointestinal system&#xD;
&#xD;
          3. Unable to avoid the following over-the-counter medications 48 hours prior to the&#xD;
             baseline period and throughout the study:&#xD;
&#xD;
               -  Medications that alter GI transit including laxatives, magnesium and aluminum&#xD;
                  containing antacids, prokinetics, erythromycin&#xD;
&#xD;
               -  Analgesic drugs including NSAIDs and cyclooxygenase-2 (COX-2) inhibitor. (NOTE:&#xD;
                  Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for&#xD;
                  cardioprotection, and birth control (but with adequate backup contraception as&#xD;
                  drug-interactions with birth control have not been conducted) are permissible.)&#xD;
&#xD;
          4. History of recent surgery (within 60 days of screening).&#xD;
&#xD;
          5. Acute or chronic illness or history of illness, which in the opinion of the&#xD;
             investigator could pose a threat or harm to the subject or obscure interpretation of&#xD;
             laboratory test results or interpretation of study data such as frequent angina, Class&#xD;
             III or IV congestive heart failure, moderate impairment of renal or hepatic function,&#xD;
             poorly controlled diabetes, etc.&#xD;
&#xD;
          6. Any clinically significant abnormalities on physical examination or laboratory&#xD;
             abnormalities identified in the medical record, as determined by the investigator.&#xD;
&#xD;
          7. Acute GI illness within 48 hours of initiation of the baseline period.&#xD;
&#xD;
          8. Females who are pregnant or breastfeeding.&#xD;
&#xD;
          9. History of excessive alcohol use or substance abuse.&#xD;
&#xD;
         10. Participation in an investigational study within the 30 days prior to dosing in the&#xD;
             present study.&#xD;
&#xD;
         11. Any other reason, which in the opinion of the investigator would confound proper&#xD;
             interpretation of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Camilleri</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>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Michael Camilleri, MD</investigator_full_name>
    <investigator_title>Professor, College of Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aprepitant</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02989467
org study id: 16-007929
nct id: NCT02989467
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This research study is being done to compare the effects of Aprepitant and placebo on fasting
      gastric volume, accommodation volume, satiation (fullness) and gastric emptying.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Gastric Emptying Half-Time of Solids as Measured by Scintigraphy
time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested
description: The time for half of the ingested solids to leave the stomach.
measure: Satiation Expressed as Volume to Fullness
time frame: Day 4, approximately 30 minutes after liquid meal
description: Subjects will do a satiation/nutrient drink test, consuming Ensure at a relatively constant rate of 30 ml/min. Subjects will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 3.
measure: Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
time frame: Day 5, approximately 15 minutes after radioactive marker is administered
description: Subjects will arrive to the Clinical Research and Trials Unit (CRTU) fasting. A radioactive marker will be administered intravenously. After a 10-15 minute wait period a fasting scan will be acquired using a dual-head gamma camera.
measure: Postprandial Gastric Volume as Measured by SPECT
time frame: Day 5, approximately 30 minutes after liquid meal
description: At the completion of the fasting scan, the subject will consume 300 ml of Ensure followed by a postprandial scan using a dual-head gamma camera.
measure: Accommodation Volume as Measured by SPECT
time frame: Day 5, approximately 30 minutes after liquid meal
description: This variable is calculated as postprandial gastric volume minus fasting volume.
measure: Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours
time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested
description: On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.
measure: Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours
time frame: Day 3, approximately 4 hours after radiolabeled meal is ingested
description: On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 4 hours.
measure: Maximum Tolerated Volume on Satiation Test
time frame: Day 4, approximately 30 minutes after liquid meal
description: On Day 4, subjects will do a satiation/nutrient drink test. Participants will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 5.
measure: Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test
time frame: Day 4, approximately 30 minutes after liquid meal
description: Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end.
measure: Aggregate Symptoms Score
time frame: Day 4, approximately 1 hour after liquid meal
description: Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end. The aggregate symptoms score is calculated by adding the mean individual scores. The lowest possible score would be 0 (none) and the highest maximum score possible is 400 (worst ever).
measure: Gastric Volume Ratio
time frame: Day 5, approximately 1 hour after radioactive marker is administered
description: Postprandial/fasting gastric volume
measure: Absolute postprandial gastric volume
time frame: Day 5, approximately 1 hour after radioactive marker is administered
description: This is the total postprandial gastric volume
arm group label: Aprepitant
arm group type: Active Comparator
description: Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive one placebo tablet daily for 5 consecutive days.
intervention type: Drug
intervention name: Aprepitant
description: Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.
arm group label: Aprepitant
other name: Emend
intervention type: Drug
intervention name: Placebo
description: Subjects will receive one placebo tablet daily for 5 consecutive days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Camilleri
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Michael Camilleri, MD
investigator title: Professor, College of Medicine
mesh term: Aprepitant
sharing ipd: Undecided