xml: <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/NCT06003829</url>
    </required_header>
    <id_info>
      <org_study_id>C5241014</org_study_id>
      <secondary_id>2023-504924-24-00</secondary_id>
      <nct_id>NCT06003829</nct_id>
    </id_info>
    <brief_title>A Study to Learn About the Tastes of Different Suspensions With the Study Medicine (PF-07923568) in Healthy Adult Participants.</brief_title>
    <official_title>A RANDOMIZED, PHASE 1, SINGLE-BLIND, MULTI-PERIOD STUDY TO INVESTIGATE THE PALATABILITY OF PF-07923568 ORAL SUSPENSION IN DIFFERENT LIQUID VEHICLES IN HEALTHY ADULT PARTICIPANTS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pfizer</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to learn about the tastes of different suspensions with the&#xD;
        study medicine called PF-07923568 in healthy adult participants. In a suspension, the&#xD;
        medicine is mixed with a liquid, usually water, in which it cannot dissolve and therefore&#xD;
        remains intact in the form of small particles.&#xD;
  &#xD;
        This study is seeking for healthy participants who:&#xD;
  &#xD;
          -  are aged 18 years of age or older.&#xD;
  &#xD;
          -  can produce a baby must agree to use a highly effective method of birth control.&#xD;
  &#xD;
          -  are confirmed to be healthy by some medical tests. This study can include both men and&#xD;
             women.&#xD;
  &#xD;
          -  have body mass index (BMI) of 16 to 32 kg/m2 and a total body weight of more than 45&#xD;
             kilograms.&#xD;
  &#xD;
        Participants will take sisunatovir prepared in 5 different suspensions and bitrex over two&#xD;
        days to see if they are good to taste. Participants will answer a questionnaire after tasting&#xD;
        each suspension. The questionnaire will be completed for each suspension. The questionnaire&#xD;
        asks participants to test each suspension at 4 different times after tasting and spitting out&#xD;
        the suspension. At least 60 minutes will pass between tasting each suspension.&#xD;
  &#xD;
        The total planned time period of participation is around 5 to 8 weeks. This includes the&#xD;
        screening period of up to 28 days. Followed by first administration of study medicine. Then a&#xD;
        3 day in-patient stay at the study clinic. It also includes a follow-up phone call that&#xD;
        happens 28-35 days after the final taste test.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">September 22, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 22, 2023</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>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Palatability Questionnaire - Mouth feel</measure>
      <time_frame>1, 5, 10, and 20 minutes after dose</time_frame>
      <description>Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Palatability Questionnaire - Bitterness</measure>
      <time_frame>1, 5, 10, and 20 minutes after dose</time_frame>
      <description>Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Palatability Questionnaire - Sweetness</measure>
      <time_frame>1, 5, 10, and 20 minutes after dose</time_frame>
      <description>Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Palatability Questionnaire - Sourness</measure>
      <time_frame>1, 5, 10, and 20 minutes after dose</time_frame>
      <description>Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Palatability Questionnaire - saltiness</measure>
      <time_frame>1, 5, 10, and 20 minutes after dose</time_frame>
      <description>Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Palatability Questionnaire - tongue/mouth burn</measure>
      <time_frame>1, 5, 10, and 20 minutes after dose</time_frame>
      <description>Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Palatability Questionnaire - overall liking</measure>
      <time_frame>1, 5, 10, and 20 minutes after dose</time_frame>
      <description>Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)</measure>
      <time_frame>Baseline up to 35 days after last dose of study intervention</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinical Laboratory Abnormalities</measure>
      <time_frame>Baseline up to Day 2</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</measure>
      <time_frame>Baseline up to Day 2</time_frame>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Actual">12</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Treatment A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment C</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Comparator</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment D</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment E</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment F</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sinsunatovir</intervention_name>
      <description>Single dose, to be spit out after tasting</description>
      <arm_group_label>Treatment A</arm_group_label>
      <arm_group_label>Treatment B</arm_group_label>
      <arm_group_label>Treatment D</arm_group_label>
      <arm_group_label>Treatment E</arm_group_label>
      <arm_group_label>Treatment F</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Bitrex</intervention_name>
      <description>Single dose, to be spit out after tasting</description>
      <arm_group_label>Treatment C</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female participants aged 18 years or older (or the minimum age of consent in&#xD;
               accordance with local regulations) at screening who are overtly healthy as determined&#xD;
               by medical evaluation including medical history, physical examination, laboratory&#xD;
               tests, blood pressure, pulse rate and standard 12-lead electrocardiogram (ECG).&#xD;
  &#xD;
            -  Body mass index (BMI) of 16-32 kg/m2; and a total body weight &gt;45 kg&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Evidence or history of clinically significant hematological, renal,&#xD;
               endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,&#xD;
               neurological, or allergic disease (including drug allergies, but excluding untreated,&#xD;
               asymptomatic, seasonal allergies at the time of dosing).&#xD;
  &#xD;
            -  Any medical or psychiatric condition including recent (within the past year) or active&#xD;
               suicidal ideation/behavior or laboratory abnormality or other conditions that may&#xD;
               increase the risk of study participation or, in the investigator's judgment, make the&#xD;
               participant inappropriate for the study.&#xD;
  &#xD;
            -  Conditions that affect ability to taste eg, dysgeusia, respiratory infection, cold,&#xD;
               etc.&#xD;
  &#xD;
            -  History of hypersensitivity to the active compounds or to any inactive ingredients&#xD;
               (excipients) contained in the formulations.&#xD;
  &#xD;
            -  Previous administration with an investigational product (drug or vaccine) within 30&#xD;
               days (or as determined by the local requirement) or 5 half-lives preceding the first&#xD;
               dose of study intervention used in this study (whichever is longer). Participation in&#xD;
               studies of other investigational products (drug or vaccine) at any time during their&#xD;
               participation in this study.&#xD;
  &#xD;
            -  A positive urine drug test at screening or admission.&#xD;
  &#xD;
            -  A positive serum pregnancy test at screening and/or positive urine/serum pregnancy&#xD;
               test in woman/women of childbearing potential (WOCBP) at Day -1&#xD;
  &#xD;
            -  Use of tobacco/nicotine containing products&#xD;
  &#xD;
            -  Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)&#xD;
               for participants &lt;60 years; and ≥150/90 mm Hg for participants ≥60 years old,&#xD;
               following at least 5 minutes of supine rest.&#xD;
  &#xD;
            -  Renal impairment as defined by an estimated glomerular filtration rate (eGFR) (units&#xD;
               of mL/min/1.73m²) &lt;60 mL/min(/1.73m²) based on 2021 chronic kidney disease&#xD;
               epidemiology (CKD-EPI).&#xD;
  &#xD;
            -  Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may&#xD;
               affect participant safety or interpretation of study results&#xD;
  &#xD;
            -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (Bili) ≥&#xD;
               1.05 × upper limit of normal (ULN). Participants with an elevated total bilirubin&#xD;
               consistent with Gilbert's Disease should have a direct bilirubin measured and would be&#xD;
               eligible for this study provided the direct bilirubin level is ≤ ULN.&#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>Pfizer CT.gov Call Center</last_name>
      <role>Study Director</role>
      <affiliation>Pfizer</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Pfizer Clinical Research Unit - Brussels</name>
        <address>
          <city>Brussels</city>
          <state>Bruxelles-capitale, Région DE</state>
          <zip>B-1070</zip>
          <country>Belgium</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <link>
      <url>https://pmiform.com/clinical-trial-info-request?StudyID=C5241014</url>
      <description>To obtain contact information for a study center near you, click here.</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Denatonium</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003829
  org study id: C5241014
  secondary id: 2023-504924-24-00
  nct id: NCT06003829
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to learn about the tastes of different suspensions with the
        study medicine called PF-07923568 in healthy adult participants. In a suspension, the
        medicine is mixed with a liquid, usually water, in which it cannot dissolve and therefore
        remains intact in the form of small particles.
  
        This study is seeking for healthy participants who:
  
          -  are aged 18 years of age or older.
  
          -  can produce a baby must agree to use a highly effective method of birth control.
  
          -  are confirmed to be healthy by some medical tests. This study can include both men and
             women.
  
          -  have body mass index (BMI) of 16 to 32 kg/m2 and a total body weight of more than 45
             kilograms.
  
        Participants will take sisunatovir prepared in 5 different suspensions and bitrex over two
        days to see if they are good to taste. Participants will answer a questionnaire after tasting
        each suspension. The questionnaire will be completed for each suspension. The questionnaire
        asks participants to test each suspension at 4 different times after tasting and spitting out
        the suspension. At least 60 minutes will pass between tasting each suspension.
  
        The total planned time period of participation is around 5 to 8 weeks. This includes the
        screening period of up to 28 days. Followed by first administration of study medicine. Then a
        3 day in-patient stay at the study clinic. It also includes a follow-up phone call that
        happens 28-35 days after the final taste test.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Palatability Questionnaire - Mouth feel
  time frame: 1, 5, 10, and 20 minutes after dose
  description: Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.
  measure: Palatability Questionnaire - Bitterness
  time frame: 1, 5, 10, and 20 minutes after dose
  description: Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.
  measure: Palatability Questionnaire - Sweetness
  time frame: 1, 5, 10, and 20 minutes after dose
  description: Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.
  measure: Palatability Questionnaire - Sourness
  time frame: 1, 5, 10, and 20 minutes after dose
  description: Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.
  measure: Palatability Questionnaire - saltiness
  time frame: 1, 5, 10, and 20 minutes after dose
  description: Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.
  measure: Palatability Questionnaire - tongue/mouth burn
  time frame: 1, 5, 10, and 20 minutes after dose
  description: Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.
  measure: Palatability Questionnaire - overall liking
  time frame: 1, 5, 10, and 20 minutes after dose
  description: Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.
  measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
  time frame: Baseline up to 35 days after last dose of study intervention
  measure: Number of Participants With Clinical Laboratory Abnormalities
  time frame: Baseline up to Day 2
  measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
  time frame: Baseline up to Day 2
  arm group label: Treatment A
  arm group type: Experimental
  arm group label: Treatment B
  arm group type: Experimental
  arm group label: Treatment C
  arm group type: Other
  description: Comparator
  arm group label: Treatment D
  arm group type: Experimental
  arm group label: Treatment E
  arm group type: Experimental
  arm group label: Treatment F
  arm group type: Experimental
  intervention type: Drug
  intervention name: Sinsunatovir
  description: Single dose, to be spit out after tasting
  arm group label: Treatment A
  arm group label: Treatment B
  arm group label: Treatment D
  arm group label: Treatment E
  arm group label: Treatment F
  intervention type: Other
  intervention name: Bitrex
  description: Single dose, to be spit out after tasting
  arm group label: Treatment C
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pfizer CT.gov Call Center
  role: Study Director
  affiliation: Pfizer
  facility: 
  country: Belgium
  url: https://pmiform.com/clinical-trial-info-request?StudyID=C5241014
  description: To obtain contact information for a study center near you, click here.
  responsible party type: Sponsor
  mesh term: Denatonium
  sharing ipd: No
  ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.