<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/NCT03245918</url>
  </required_header>
  <id_info>
    <org_study_id>1000056100</org_study_id>
    <nct_id>NCT03245918</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers</brief_title>
  <official_title>Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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>
      Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and&#xD;
      vomiting (CINV) are still common and are among the most distressing side effects of&#xD;
      chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid&#xD;
      aprepitant formulation would be ideal for oral administration to patients unable to swallow&#xD;
      capsules.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">January 5, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bioavailability of the oral suspension relative to the capsule</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Chemotherapy-induced Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Aprepitant Capsule Study Period #1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Aprepitant Oral Suspension Study Period#1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aprepitant Capsule 125 MG</intervention_name>
    <description>Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period</description>
    <arm_group_label>Aprepitant Capsule Study Period #1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aprepitant oral suspension 20 mg/mL</intervention_name>
    <description>Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period</description>
    <arm_group_label>Aprepitant Oral Suspension Study Period#1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects as determined by responsible physician (see 4.3) (i.e.&#xD;
             have no clinically significant diseases captured in the medical history, on physical&#xD;
             examination and/or laboratory tests)&#xD;
&#xD;
          -  18 to 55 years of age&#xD;
&#xD;
          -  BMI within 18.5 to 30 kg/m2&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
          -  Systolic blood pressure between 90-140 mmHg, diastolic blood pressure between 60-90&#xD;
             mmHg, and heart rate between 60-100 bpm, inclusive.&#xD;
&#xD;
          -  Female subjects of childbearing potential should be either sexually inactive&#xD;
             (abstinent) or be using one of acceptable methods of birth control for 15 days prior&#xD;
             to the first dose of the study, throughout the study and for at least 30 days after&#xD;
             the last aprepitant dose.&#xD;
&#xD;
          -  Able to swallow whole aprepitant capsules&#xD;
&#xD;
          -  Willingness to adhere to the protocol requirements as evidenced by the informed&#xD;
             consent form (ICF) duly read, signed and dated by the volunteer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant illness or surgery within 8 weeks prior to dosing.&#xD;
&#xD;
          -  Positive for hepatitis B, hepatitis C, or HIV at screening as per medical history.&#xD;
&#xD;
          -  History of allergic reactions to the study drug and/or its excipients.&#xD;
&#xD;
          -  Subjects concurrently treated with drugs that are metabolized through CYP3A4,&#xD;
             including but not limited to pimozide, terfenadine, astemizole, or cisapride,&#xD;
             ketoconazole, itraconazole, clarithromycin, diltiazem, warfarin, rifampin,&#xD;
             carbamazepine, and phenytoin etc.&#xD;
&#xD;
          -  History of drug or alcohol abuse within the last 6 months.&#xD;
&#xD;
          -  Severe mental disorders.&#xD;
&#xD;
          -  Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL&#xD;
             of whole blood within 56 days prior to drug administration.&#xD;
&#xD;
          -  Pregnant or breastfeeding.&#xD;
&#xD;
          -  Use of recreational drugs, prescription medications (other than hormonal contraceptive&#xD;
             agents),non-prescription medications (over-the-counter) or natural health products&#xD;
             within 7 days or 5 half-lives (whichever is longer) prior to the administration of the&#xD;
             first dose of study medication.&#xD;
&#xD;
          -  Consumed grapefruit or grapefruit products within 7 days of each study period&#xD;
&#xD;
          -  Any reason which, in the opinion of the investigator, would prevent the subject from&#xD;
             participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Patel P, Nathan PC, Walker SE, Zupanec S, Volpe J, Dupuis LL. Relative bioavailability of an extemporaneously prepared aprepitant oral suspension in healthy adults. J Oncol Pharm Pract. 2019 Dec;25(8):1907-1915. doi: 10.1177/1078155219828806. Epub 2019 Feb 5.</citation>
    <PMID>31694495</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>April 1, 2022</last_update_submitted>
  <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Lee Dupuis</investigator_full_name>
    <investigator_title>Health Clinician Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aprepitant</mesh_term>
    <mesh_term>Fosaprepitant</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/NCT03245918
org study id: 1000056100
nct id: NCT03245918
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and
      vomiting (CINV) are still common and are among the most distressing side effects of
      chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid
      aprepitant formulation would be ideal for oral administration to patients unable to swallow
      capsules.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Bioavailability of the oral suspension relative to the capsule
time frame: 6 weeks
arm group label: Aprepitant Capsule Study Period #1
arm group type: Other
arm group label: Aprepitant Oral Suspension Study Period#1
arm group type: Other
intervention type: Drug
intervention name: Aprepitant Capsule 125 MG
description: Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period
arm group label: Aprepitant Capsule Study Period #1
intervention type: Drug
intervention name: Aprepitant oral suspension 20 mg/mL
description: Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period
arm group label: Aprepitant Oral Suspension Study Period#1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
citation: Patel P, Nathan PC, Walker SE, Zupanec S, Volpe J, Dupuis LL. Relative bioavailability of an extemporaneously prepared aprepitant oral suspension in healthy adults. J Oncol Pharm Pract. 2019 Dec;25(8):1907-1915. doi: 10.1177/1078155219828806. Epub 2019 Feb 5.
PMID: 31694495
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Lee Dupuis
investigator title: Health Clinician Scientist
mesh term: Vomiting
mesh term: Aprepitant
mesh term: Fosaprepitant
sharing ipd: No