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/NCT05987072</url>
    </required_header>
    <id_info>
      <org_study_id>C5241018</org_study_id>
      <nct_id>NCT05987072</nct_id>
    </id_info>
    <brief_title>A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults.</brief_title>
    <official_title>A PHASE 1, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY FOLLOWING SINGLE AND MULTIPLE DOSES OF SISUNATOVIR IN CHINESE HEALTHY PARTICIPANTS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pfizer</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to learn about:&#xD;
  &#xD;
          -  The activity of sisunotavir in the body over a period. It includes the processes by&#xD;
             which sisunotavir is absorbed, distributed in the body, localized in the tissues, and&#xD;
             removed from the body.&#xD;
  &#xD;
          -  safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult&#xD;
             participants.&#xD;
  &#xD;
        This information is being collected to support further clinical development as well as&#xD;
        medicine registration in China.&#xD;
  &#xD;
        This study is seeking for participants who:&#xD;
  &#xD;
          -  are male and female participants aged 18 to 65 years of age.&#xD;
  &#xD;
          -  are male and female participants who are healthy as seen by medical tests.&#xD;
  &#xD;
          -  have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50&#xD;
             kilograms (110 pounds).&#xD;
  &#xD;
        About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200&#xD;
        milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be&#xD;
        followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4&#xD;
        to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day&#xD;
        with a meal.&#xD;
  &#xD;
        The total time of participants will be in the study is about 71 days. This includes the&#xD;
        screening visit to the Follow-up contact. In screening visit, participants will be tested to&#xD;
        see if they are fit to take part in the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 21, 2024</start_date>
    <completion_date type="Anticipated">April 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 27, 2024</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>
      <intervention_model_description>single-arm to investigate PK, safety and tolerability of 200 mg sisunatovir given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state in Chinese healthy participants.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax) on Day 1</measure>
      <time_frame>0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post dose on Day1</time_frame>
      <description>Maximum Observed Plasma Concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) on Day1</measure>
      <time_frame>0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post dose on Day1</time_frame>
      <description>Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC0-12) on Day1</measure>
      <time_frame>0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day1</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day1</measure>
      <time_frame>0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post dose on Day1</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax on Day 4</measure>
      <time_frame>0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post first dose on Day 4</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC(0-12) on Day 4</measure>
      <time_frame>0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post first dose on Day 4</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax on Day 8</measure>
      <time_frame>0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post first dose on Day 8</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC(0-12) on Day 8</measure>
      <time_frame>0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post first dose on Day 8</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Respiratory Syncytial Virus Infection</condition>
    <arm_group>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This only arm will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sisunatovir</intervention_name>
      <description>Will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state</description>
      <arm_group_label>Arm 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Chinese male and female participants aged 18 to 65 years of age, inclusive, at the&#xD;
               time of signing of the informed consent document (ICD).&#xD;
  &#xD;
            -  Male and female participants who are overtly healthy as determined by medical&#xD;
               evaluation including medical history, physical examination, standard 12-lead ECG, and&#xD;
               laboratory tests.&#xD;
  &#xD;
            -  Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight &gt;50 kg (110 lb).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
               pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or&#xD;
               allergic disease (including drug allergies, but excluding untreated, asymptomatic,&#xD;
               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 or&#xD;
               situations related to coronavirus disease 2019 (COVID-19) pandemic that may increase&#xD;
               the risk of study participation or, in the investigator's judgment, make the&#xD;
               participant inappropriate for the study.&#xD;
  &#xD;
            -  Use of prescription or nonprescription drugs and dietary and herbal supplements within&#xD;
               7 days or 5 half-lives (whichever is longer) prior to the first dose of study&#xD;
               intervention with the exception of moderate/strong cytochrome P4503A (CYP3A) inducers&#xD;
               or time-dependent inhibitors which are prohibited within 14 days plus 5 half-lives&#xD;
               prior to the first dose of study intervention.&#xD;
  &#xD;
            -  A positive urine drug test, confirmed by a repeat test, if deemed necessary.&#xD;
  &#xD;
            -  Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic),&#xD;
               following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm&#xD;
               Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP&#xD;
               values should be used to determine the participant's eligibility.&#xD;
  &#xD;
            -  Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may&#xD;
               affect participant safety or interpretation of study results (eg, QTc corrected using&#xD;
               Fridericia's formula [QTcF] &gt;450 ms, complete left bundle branch block [LBBB], signs&#xD;
               of an acute or indeterminate- age myocardial infarction, ST-segment and T-wave [ST-T]&#xD;
               interval changes suggestive of myocardial ischemia, second- or thirddegree AV block,&#xD;
               or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is&#xD;
               &gt;450 ms, this interval should be rate-corrected using the Fridericia method only and&#xD;
               the resulting QTcF should be used for decision making and reporting. If QTcF exceeds&#xD;
               450 ms, or quantitative restrictions (QRS) exceeds 120 ms, the ECG should be repeated&#xD;
               twice and the average of the 3 QTcF or QRS values used to determine the participant's&#xD;
               eligibility. Computer interpreted- ECGs should be overread by a physician experienced&#xD;
               in reading ECGs before excluding a participant.&#xD;
  &#xD;
            -  Participants with ANY of the following abnormalities in clinical laboratory tests at&#xD;
               screening, as assessed by the study-specific laboratory and confirmed by a single&#xD;
               repeat test, if deemed necessary:&#xD;
  &#xD;
            -  Glomerular filtration rate (GFR) &lt;60 mL/min/1.73m2 based on chronic kidney disease&#xD;
               epidemiology (CKD-EPI equation);&#xD;
  &#xD;
            -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.05 × upper&#xD;
               limit of normal (ULN);&#xD;
  &#xD;
            -  Gamma-glutamyl transferase (GGT) &gt; 1.05 × ULN;&#xD;
  &#xD;
            -  Alkaline phosphatase &gt; 1.05 × ULN;&#xD;
  &#xD;
            -  Total bilirubin level ≥1.05 × ULN; participants with a history of Gilbert's syndrome&#xD;
               may have direct bilirubin measured and would be eligible for this study provided the&#xD;
               direct bilirubin level is ≤ ULN.&#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>Pfizer CT.gov Call Center</last_name>
      <role>Study Director</role>
      <affiliation>Pfizer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Huashan Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <link>
      <url>https://pmiform.com/clinical-trial-info-request?StudyID=C5241018</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>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Respiratory Syncytial Virus Infections</mesh_term>
    </condition_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/NCT05987072
  org study id: C5241018
  nct id: NCT05987072
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to learn about:
  
          -  The activity of sisunotavir in the body over a period. It includes the processes by
             which sisunotavir is absorbed, distributed in the body, localized in the tissues, and
             removed from the body.
  
          -  safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult
             participants.
  
        This information is being collected to support further clinical development as well as
        medicine registration in China.
  
        This study is seeking for participants who:
  
          -  are male and female participants aged 18 to 65 years of age.
  
          -  are male and female participants who are healthy as seen by medical tests.
  
          -  have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50
             kilograms (110 pounds).
  
        About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200
        milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be
        followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4
        to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day
        with a meal.
  
        The total time of participants will be in the study is about 71 days. This includes the
        screening visit to the Follow-up contact. In screening visit, participants will be tested to
        see if they are fit to take part in the study.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: single-arm to investigate PK, safety and tolerability of 200 mg sisunatovir given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state in Chinese healthy participants.
  primary purpose: Other
  masking: None (Open Label)
  measure: Maximum Observed Plasma Concentration (Cmax) on Day 1
  time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post dose on Day1
  description: Maximum Observed Plasma Concentration
  measure: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) on Day1
  time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post dose on Day1
  description: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
  measure: Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC0-12) on Day1
  time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose on Day1
  measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day1
  time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post dose on Day1
  measure: Cmax on Day 4
  time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post first dose on Day 4
  measure: AUC(0-12) on Day 4
  time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post first dose on Day 4
  measure: Cmax on Day 8
  time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post first dose on Day 8
  measure: AUC(0-12) on Day 8
  time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours post first dose on Day 8
  arm group label: Arm 1
  arm group type: Experimental
  description: This only arm will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state
  intervention type: Drug
  intervention name: Sisunatovir
  description: Will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state
  arm group label: Arm 1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pfizer CT.gov Call Center
  role: Study Director
  affiliation: Pfizer
  last name: Pfizer CT.gov Call Center
  phone: 1-800-718-1021
  email: ClinicalTrials.gov_Inquiries@pfizer.com
  facility: 
  country: China
  url: https://pmiform.com/clinical-trial-info-request?StudyID=C5241018
  description: To obtain contact information for a study center near you, click here.
  responsible party type: Sponsor
  mesh term: Respiratory Syncytial Virus Infections
  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.