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/NCT06037031</url>
    </required_header>
    <id_info>
      <org_study_id>C5241016</org_study_id>
      <nct_id>NCT06037031</nct_id>
    </id_info>
    <brief_title>A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function</brief_title>
    <official_title>A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07923568 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION</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>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 understand how the loss of kidney function affects study&#xD;
        medicine (PF-07923568) in the body. People with some level of loss of kidney function may&#xD;
        process PF-07923568 differently from healthy people. PF-07923568 is developed as a possible&#xD;
        treatment for respiratory syncytial virus (RSV) infection. RSV is a common virus that affects&#xD;
        the lungs and usually causes mild, cold-like symptoms. RSV can cause severe lung infections&#xD;
        in infants, elderly, and adults with other serious medical conditions.&#xD;
  &#xD;
        This study is seeking participants who:&#xD;
  &#xD;
          -  Have less than 25% difference in kidney function between 2 screening visits.&#xD;
  &#xD;
          -  Meet the eGFR criteria for being assigned to groups. eGFR tells how well the kidney is&#xD;
             filtering.&#xD;
  &#xD;
          -  Are not on hemodialysis. Hemodialysis is a type of treatment that helps the body remove&#xD;
             extra fluid and waste products from the blood when the kidneys are not able to.&#xD;
  &#xD;
        Participants will take the study medicine as capsules by mouth once at the study clinic. The&#xD;
        participants will stay at the study clinic for about 5 days. During that time, the study team&#xD;
        will monitor the participants. The study team will take some blood samples to test the level&#xD;
        of PF-07923568. This will help us understand if some level of loss of kidney function will&#xD;
        have an effect on the study medicine PF-07923568.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 4, 2023</start_date>
    <completion_date type="Anticipated">March 12, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 12, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
      <time_frame>Baseline through Day 5</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)</measure>
      <time_frame>Baseline through Day 5</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
      <time_frame>Baseline through Day 5</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)</measure>
      <time_frame>Baseline through Day 36</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Change From Baseline in Laboratory Tests Results</measure>
      <time_frame>Baseline through Day 5</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</measure>
      <time_frame>Baseline through Day 5</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)</measure>
      <time_frame>Baseline through Day 5</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Renal Impairment</condition>
    <arm_group>
      <arm_group_label>Cohort 1: Severe Renal Impairment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with severe renal impairment will receive a single oral dose of PF-07923568</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2: Normal Renal Function</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with normal renal function will receive a single oral dose of PF-07923568</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3 (Optional): Moderate Renal Impairment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with moderate renal impairment will receive a single oral dose of PF-07923568</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Drug: PF-07923568</intervention_name>
      <description>A single dose of PF-07923568 administered orally as 4 capsules</description>
      <arm_group_label>Cohort 1: Severe Renal Impairment</arm_group_label>
      <arm_group_label>Cohort 2: Normal Renal Function</arm_group_label>
      <arm_group_label>Cohort 3 (Optional): Moderate Renal Impairment</arm_group_label>
      <other_name>Sisunatovir</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Stable renal function defined as ≤25% difference between 2 measurements of absolute&#xD;
               estimated glomerular filtration rate (eGFR) during screening.&#xD;
  &#xD;
            2. Meet the eGFR criteria for cohort placement during the screening period.&#xD;
  &#xD;
            3. Body mass index (BMI) of 16-32 kg/m2; and a total body weight &gt;45 kg (99 lb.).&#xD;
  &#xD;
            4. For Cohort 2 Normal Renal Function Group Only: At screening, meet the&#xD;
               demographic-matching criteria, including body weight within ±15 kg and age within ±10&#xD;
               years, of the average of the pooled renal impairment cohort.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants with acute renal disease.&#xD;
  &#xD;
            2. Participants who are clinically nephrotic.&#xD;
  &#xD;
            3. Participants requiring hemodialysis.&#xD;
  &#xD;
            4. Renal allograft recipients.&#xD;
  &#xD;
            5. Participants who have previously received a kidney, liver, or heart transplant.&#xD;
  &#xD;
            6. Urinary incontinence without catheterization.&#xD;
  &#xD;
            7. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;&#xD;
               positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody&#xD;
               (HCVAb).&#xD;
  &#xD;
            8. History of alcohol abuse or binge drinking and/or any other illicit drug use or&#xD;
               dependence within 6 months of Screening.&#xD;
  &#xD;
            9. Participation in studies of other investigational products (drug or vaccine) at any&#xD;
               time during their participation in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 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>
    <link>
      <url>https://pmiform.com/clinical-trial-info-request?StudyID=C5241016</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>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>Renal Insufficiency</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/NCT06037031
  org study id: C5241016
  nct id: NCT06037031
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to understand how the loss of kidney function affects study
        medicine (PF-07923568) in the body. People with some level of loss of kidney function may
        process PF-07923568 differently from healthy people. PF-07923568 is developed as a possible
        treatment for respiratory syncytial virus (RSV) infection. RSV is a common virus that affects
        the lungs and usually causes mild, cold-like symptoms. RSV can cause severe lung infections
        in infants, elderly, and adults with other serious medical conditions.
  
        This study is seeking participants who:
  
          -  Have less than 25% difference in kidney function between 2 screening visits.
  
          -  Meet the eGFR criteria for being assigned to groups. eGFR tells how well the kidney is
             filtering.
  
          -  Are not on hemodialysis. Hemodialysis is a type of treatment that helps the body remove
             extra fluid and waste products from the blood when the kidneys are not able to.
  
        Participants will take the study medicine as capsules by mouth once at the study clinic. The
        participants will stay at the study clinic for about 5 days. During that time, the study team
        will monitor the participants. The study team will take some blood samples to test the level
        of PF-07923568. This will help us understand if some level of loss of kidney function will
        have an effect on the study medicine PF-07923568.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Maximum Observed Plasma Concentration (Cmax)
  time frame: Baseline through Day 5
  measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
  time frame: Baseline through Day 5
  measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
  time frame: Baseline through Day 5
  measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
  time frame: Baseline through Day 36
  measure: Number of Participants With Change From Baseline in Laboratory Tests Results
  time frame: Baseline through Day 5
  measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
  time frame: Baseline through Day 5
  measure: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)
  time frame: Baseline through Day 5
  arm group label: Cohort 1: Severe Renal Impairment
  arm group type: Experimental
  description: Participants with severe renal impairment will receive a single oral dose of PF-07923568
  arm group label: Cohort 2: Normal Renal Function
  arm group type: Experimental
  description: Participants with normal renal function will receive a single oral dose of PF-07923568
  arm group label: Cohort 3 (Optional): Moderate Renal Impairment
  arm group type: Experimental
  description: Participants with moderate renal impairment will receive a single oral dose of PF-07923568
  intervention type: Drug
  intervention name: Drug: PF-07923568
  description: A single dose of PF-07923568 administered orally as 4 capsules
  arm group label: Cohort 1: Severe Renal Impairment
  arm group label: Cohort 2: Normal Renal Function
  arm group label: Cohort 3 (Optional): Moderate Renal Impairment
  other name: Sisunatovir
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 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
  url: https://pmiform.com/clinical-trial-info-request?StudyID=C5241016
  description: To obtain contact information for a study center near you, click here.
  responsible party type: Sponsor
  mesh term: Renal Insufficiency
  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.