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/NCT06003777</url>
    </required_header>
    <id_info>
      <org_study_id>C4001001</org_study_id>
      <nct_id>NCT06003777</nct_id>
    </id_info>
    <brief_title>A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults</brief_title>
    <official_title>A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, CROSSOVER, FIRST-IN-HUMAN STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-06954522 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 purposes of this study are:&#xD;
  &#xD;
          -  To see how the new medicine (PF-06954522) under study behave. And if there are any&#xD;
             important side effects. A side effect is a reaction (expected or unexpected) to a&#xD;
             medicine or treatment you take. The study will see how people feel after taking single&#xD;
             increasing amount of the medicine by mouth.&#xD;
  &#xD;
          -  To measure the amount of study medicine in your blood after the medicine is taken by&#xD;
             mouth.&#xD;
  &#xD;
        This study is seeking for participants who:&#xD;
  &#xD;
          -  are females of 18 to 65 years old and are not able to give birth to a child.&#xD;
  &#xD;
          -  are males of 18 to 65 years old.&#xD;
  &#xD;
          -  have body mass index of 16 to 31 kilograms per meter squared.&#xD;
  &#xD;
          -  have a total body weight of more than 50 kilograms (110 pounds).&#xD;
  &#xD;
        Participants will be chosen by chance, like drawing names out of a hat to receive either:&#xD;
  &#xD;
          -  study medicine (PF-06954522)&#xD;
  &#xD;
          -  or placebo (a pill that has no medicine in it).&#xD;
  &#xD;
        Participants may receive up to 4 amounts of study medicine and up to 2 amounts of placebo.&#xD;
        The time frame of the study is approximately up to 36 days for each group and participants&#xD;
        will stay at CRU for 20 days.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">February 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 20, 2024</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>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Following Single Ascending Dose</measure>
      <time_frame>Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Clinical Laboratory Abnormalities</measure>
      <time_frame>Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Clinically Significant Change from Baseline in Vital Signs</measure>
      <time_frame>Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings</measure>
      <time_frame>Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings</measure>
      <time_frame>Day 1 in each period for approximately 8 hours (each period is 7 days) up to approximately 36 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Clinically Significant Change from Baseline in Physical Examination Findings</measure>
      <time_frame>Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax) of PF-06954522</measure>
      <time_frame>Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06954522</measure>
      <time_frame>Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06954522</measure>
      <time_frame>Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06954522</measure>
      <time_frame>Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma Half-Life (t1/2) of PF-06954522</measure>
      <time_frame>Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Healthy Participants</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single dose administration of PF-06954522 and placebo. Participants will receive up to 5 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single dose administration of PF-06954522 and placebo. Participants will receive up to 4 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single dose administration of PF-06954522 and placebo. Participants will receive up to 2 dose levels of PF-06954522 and up to 1 dose level of matching placebo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PF-06954522</intervention_name>
      <description>PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be administered as oral suspensions as escalating single doses to be determined.</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and female participants of non-childbearing potential aged 18 to 65 years,&#xD;
               inclusive, at screening who are overtly healthy as determined by medical evaluation&#xD;
               including medical history, physical examination, laboratory tests, and cardiac&#xD;
               monitoring.&#xD;
  &#xD;
            2. BMI of 16 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lb).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. 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;
            2. 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 or strong cytochrome P450 3A (CYP3A)&#xD;
               inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to&#xD;
               the first dose of study intervention.&#xD;
  &#xD;
            3. 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;
            4. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may&#xD;
               affect participant safety or interpretation of study results&#xD;
  &#xD;
            5. Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of &lt;75&#xD;
               mL/min/1.73 m².&#xD;
  &#xD;
            6. 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;
                 -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin&#xD;
  &#xD;
                      -  1.05 × upper limit of normal (ULN);&#xD;
  &#xD;
                 -  TSH &gt; ULN;&#xD;
  &#xD;
                 -  HbA1c ≥6.5%;&#xD;
  &#xD;
                 -  Hematuria as defined by ≥1+ heme on urine dipstick;&#xD;
  &#xD;
                 -  Albuminuria as defined by urine albumin/creatinine ratio (UACR) &gt;30 mg/g.&#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>Pfizer Clinical Research Unit - New Haven</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06511</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://pmiform.com/clinical-trial-info-request?StudyID=C4001001</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 3, 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 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT06003777
  org study id: C4001001
  nct id: NCT06003777
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purposes of this study are:
  
          -  To see how the new medicine (PF-06954522) under study behave. And if there are any
             important side effects. A side effect is a reaction (expected or unexpected) to a
             medicine or treatment you take. The study will see how people feel after taking single
             increasing amount of the medicine by mouth.
  
          -  To measure the amount of study medicine in your blood after the medicine is taken by
             mouth.
  
        This study is seeking for participants who:
  
          -  are females of 18 to 65 years old and are not able to give birth to a child.
  
          -  are males of 18 to 65 years old.
  
          -  have body mass index of 16 to 31 kilograms per meter squared.
  
          -  have a total body weight of more than 50 kilograms (110 pounds).
  
        Participants will be chosen by chance, like drawing names out of a hat to receive either:
  
          -  study medicine (PF-06954522)
  
          -  or placebo (a pill that has no medicine in it).
  
        Participants may receive up to 4 amounts of study medicine and up to 2 amounts of placebo.
        The time frame of the study is approximately up to 36 days for each group and participants
        will stay at CRU for 20 days.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Following Single Ascending Dose
  time frame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
  measure: Number of Participants with Clinical Laboratory Abnormalities
  time frame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
  measure: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
  time frame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
  measure: Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings
  time frame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
  measure: Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings
  time frame: Day 1 in each period for approximately 8 hours (each period is 7 days) up to approximately 36 days
  measure: Number of Participants with Clinically Significant Change from Baseline in Physical Examination Findings
  time frame: Day 1 to Day 7 in each period (each period is 7 days) up to approximately 36 days
  measure: Maximum Observed Plasma Concentration (Cmax) of PF-06954522
  time frame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
  measure: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06954522
  time frame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
  measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06954522
  time frame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
  measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06954522
  time frame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
  measure: Plasma Half-Life (t1/2) of PF-06954522
  time frame: Day 1-3 in each period for approximately 72 hours (each period is 7 days) up to approximately 36 days
  arm group label: Cohort 1
  arm group type: Experimental
  description: Single dose administration of PF-06954522 and placebo. Participants will receive up to 5 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.
  arm group label: Cohort 2
  arm group type: Experimental
  description: Single dose administration of PF-06954522 and placebo. Participants will receive up to 4 dose levels of PF-06954522 and up to 2 dose levels of matching placebo.
  arm group label: Cohort 3
  arm group type: Experimental
  description: Single dose administration of PF-06954522 and placebo. Participants will receive up to 2 dose levels of PF-06954522 and up to 1 dose level of matching placebo.
  intervention type: Drug
  intervention name: PF-06954522
  description: PF-06954522 will be administered as oral suspensions as escalating single doses to be determined.
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be administered as oral suspensions as escalating single doses to be determined.
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  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: 
  status: Recruiting
  country: United States
  url: https://pmiform.com/clinical-trial-info-request?StudyID=C4001001
  description: To obtain contact information for a study center near you, click here.
  responsible party type: Sponsor
  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.