<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/NCT04427917</url>
  </required_header>
  <id_info>
    <org_study_id>C1061010</org_study_id>
    <secondary_id>2020-000218-13</secondary_id>
    <secondary_id>JAPANESE BRIDGING</secondary_id>
    <nct_id>NCT04427917</nct_id>
  </id_info>
  <brief_title>Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants</brief_title>
  <official_title>A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-06835919 IN HEALTHY ADULT JAPANESE 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>
      This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of&#xD;
      multiple oral doses of PF-06835919 in healthy adult Japanese participants.&#xD;
&#xD;
      A total of approximately 8 healthy participants will be enrolled in this study. Participants&#xD;
      will be randomized to 2 groups to receive PF-06835919 or placebo treatment with a&#xD;
      randomization ratio of 3:1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a Phase 1, randomized, double-blind, sponsor-open, placebo-controlled study in healthy adult Japanese participants.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>double</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study</measure>
    <time_frame>Baseline (Day 1) to follow-up (Day 42)</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Laboratory Findings of Potential Clinical Importance</measure>
    <time_frame>Day 1 to Day 10</time_frame>
    <description>To determine if there were any clinically significant laboratory abnormalities, haematological (hemoglobin, hematocrit, red blood cell count, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes), clinical chemistry (blood urea nitrogen, glucose [fasting], calcium, sodium, potassium, chloride, bicarbonate, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein) and urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With ECG Data of Potential Clinical Concern</measure>
    <time_frame>Day 1 to Day 10</time_frame>
    <description>ECG endpoints (QTcF, PR and QRS) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1.maximum post-dose QTcF ≤450msec, 450 - ≤480msec, 480 - ≤500msec and &gt;500msec; 2. PR max. ≥300ms; 3. QRS max. ≥140ms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern</measure>
    <time_frame>From Study Day 1 up tp Study Day 10</time_frame>
    <description>Single supine blood pressure and pulse measurements meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. Systolic Blood Pressure (BP) min. &lt;90mm Hg; 2. Diastolic BP min. &lt;50mm Hg; 3. Supine pulse rate min. &lt;40 bpm, max. &gt;120 bpm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Maximum Plasma Concentration (Cmax) of PF-06835919 on Day 1 and Day 7</measure>
    <time_frame>Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7</time_frame>
    <description>Cmax was defined as maximum observed plasma concentration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of PF-06835919 on Day 1 and Day 7</measure>
    <time_frame>Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7</time_frame>
    <description>AUCtau was defined as area under the plasma concentration-time curve over dosing interval.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Time for Maximum Observed Concentration (Tmax) of PF-06835919 on Day 1 and Day 7</measure>
    <time_frame>Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7</time_frame>
    <description>Tmax was defined as Time for maximum observed concentration of PF-06835919.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of Terminal Half-life (t1/2) of PF-06835919 on Day 7</measure>
    <time_frame>Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 7</time_frame>
    <description>t1/2 was defined as terminal half-life.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PF-06835919</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06835919</intervention_name>
    <description>PF-06835919 300 mg repeated doses</description>
    <arm_group_label>PF-06835919</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo repeated doses</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of&#xD;
             signing the ICD.&#xD;
&#xD;
          2. A Japanese participant is defined as having 4 biological Japanese grandparents who&#xD;
             were born in Japan.&#xD;
&#xD;
          3. Male and female participants who are overtly healthy as determined by medical&#xD;
             evaluation including medical history, physical examination, laboratory tests, and&#xD;
             cardiovascular tests.&#xD;
&#xD;
          4. Participants who are willing and able to comply with all scheduled visits, treatment&#xD;
             plan, laboratory tests, lifestyle considerations, and other study procedures.&#xD;
&#xD;
          5. BMI of 17.5 to 30.5 kg/m2; and a total body weight &gt;50 kg (110 lb).&#xD;
&#xD;
          6. Capable of giving signed informed consent as described in Appendix 1, which includes&#xD;
             compliance with the requirements and restrictions listed in the ICD and in this&#xD;
             protocol.&#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. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).&#xD;
&#xD;
          3. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV,&#xD;
             HBsAg, HBcAb or HCVAb. Hepatitis B vaccination (positive HBsAb) is allowed.&#xD;
&#xD;
          4. Other medical or psychiatric condition including recent (within the past year) or&#xD;
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk&#xD;
             of study participation or, in the investigator's judgment, make the participant&#xD;
             inappropriate for the study.&#xD;
&#xD;
          5. 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 (Refer to Section 6.5 for additional details).&#xD;
&#xD;
          6. Previous administration with an investigational drug within 30 days (or as determined&#xD;
             by the local requirement) or 5 half-lives preceding the first dose of study&#xD;
             intervention used in this study (whichever is longer).&#xD;
&#xD;
          7. A positive urine drug test.&#xD;
&#xD;
          8. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least&#xD;
             5 minutes of supine rest: If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the&#xD;
             BP should be repeated 2 more times and the average of the 3 BP values should be used&#xD;
             to determine the participant's eligibility.&#xD;
&#xD;
          9. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may&#xD;
             affect participant safety or interpretation of study results (eg, baseline QTc&#xD;
             interval &gt;450 msec, complete LBBB, signs of an acute or indeterminate age myocardial&#xD;
             infarction, ST T interval changes suggestive of myocardial ischemia, second or third&#xD;
             degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline&#xD;
             uncorrected QT interval is &gt;450 msec, this interval should be rate corrected using the&#xD;
             Fridericia method (QTcF) and the resulting QTcF should be used for decision making and&#xD;
             reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be&#xD;
             repeated 2 more times and the average of the 3 QTc or QRS values should be used to&#xD;
             determine the participant's eligibility. Computer interpreted ECGs should be overread&#xD;
             by a physician experienced in reading ECGs before excluding participants.&#xD;
&#xD;
         10. 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;
               -  AST or ALT level ≥1.25 × ULN;&#xD;
&#xD;
               -  Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's&#xD;
                  syndrome may have direct bilirubin measured and would be eligible for this study&#xD;
                  provided the direct bilirubin level is ≤ ULN.&#xD;
&#xD;
         11. History of alcohol abuse or binge drinking and/or any other illicit drug use or&#xD;
             dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5&#xD;
             (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,&#xD;
             alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1&#xD;
             ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).&#xD;
&#xD;
         12. Use of tobacco- or nicotine-containing products in excess of the equivalent &gt;5&#xD;
             cigarettes/day or 2 chews of tobacco per day.&#xD;
&#xD;
         13. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more&#xD;
             within 60 days prior to dosing.&#xD;
&#xD;
         14. Unwilling or unable to comply with the criteria in the Lifestyle Considerations&#xD;
             section of this protocol.&#xD;
&#xD;
         15. Investigator site staff or Pfizer employees directly involved in the conduct of the&#xD;
             study, site staff otherwise supervised by the investigator, and their respective&#xD;
             family members.&#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>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brussels Clinical Research Unit</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=C1061010</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>March 24, 2022</results_first_submitted>
  <results_first_submitted_qc>March 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2022</results_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NASH, KHK, PF-06835919, Japanese</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT04427917/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT04427917/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All participants were screened within 28 days of the first dose of study intervention. Eligible participants were admitted to the Clinical Research Unit.</recruitment_details>
      <pre_assignment_details>A total of 8 healthy participants were enrolled in this study. Participants were randomized to 2 groups to receive PF-06835919 or placebo treatment with a randomization ratio of 3:1.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo Daily (QD)</title>
          <description>Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
        </group>
        <group group_id="P2">
          <title>PF-06835919 300 mg Daily (QD)</title>
          <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set included all participants who randomly assigned to study intervention and received at least 1 dose of study intervention.</population>
      <group_list>
        <group group_id="B1">
          <title>PF-06835919 300 mg Daily (QD)</title>
          <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Daily (QD)</title>
          <description>Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.</description>
        <time_frame>Baseline (Day 1) to follow-up (Day 42)</time_frame>
        <population>All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Daily (QD)</title>
            <description>Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
          <group group_id="O2">
            <title>PF-06835919 300 mg Daily (QD)</title>
            <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.</description>
          <population>All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants discontinued from study due to adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinical Laboratory Findings of Potential Clinical Importance</title>
        <description>To determine if there were any clinically significant laboratory abnormalities, haematological (hemoglobin, hematocrit, red blood cell count, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes), clinical chemistry (blood urea nitrogen, glucose [fasting], calcium, sodium, potassium, chloride, bicarbonate, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein) and urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.</description>
        <time_frame>Day 1 to Day 10</time_frame>
        <population>All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Daily (QD)</title>
            <description>Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
          <group group_id="O2">
            <title>PF-06835919 300 mg Daily (QD)</title>
            <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Laboratory Findings of Potential Clinical Importance</title>
          <description>To determine if there were any clinically significant laboratory abnormalities, haematological (hemoglobin, hematocrit, red blood cell count, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes), clinical chemistry (blood urea nitrogen, glucose [fasting], calcium, sodium, potassium, chloride, bicarbonate, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein) and urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.</description>
          <population>All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With ECG Data of Potential Clinical Concern</title>
        <description>ECG endpoints (QTcF, PR and QRS) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1.maximum post-dose QTcF ≤450msec, 450 - ≤480msec, 480 - ≤500msec and &gt;500msec; 2. PR max. ≥300ms; 3. QRS max. ≥140ms.</description>
        <time_frame>Day 1 to Day 10</time_frame>
        <population>All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Daily (QD)</title>
            <description>Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
          <group group_id="O2">
            <title>PF-06835919 300 mg Daily (QD)</title>
            <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With ECG Data of Potential Clinical Concern</title>
          <description>ECG endpoints (QTcF, PR and QRS) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1.maximum post-dose QTcF ≤450msec, 450 - ≤480msec, 480 - ≤500msec and &gt;500msec; 2. PR max. ≥300ms; 3. QRS max. ≥140ms.</description>
          <population>All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR Interval Value ≥ 300 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration Value ≥140 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval Value ≤450 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>450 msec&lt;QTcF Interval Value ≤480 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>480 msec&lt;QTcF Interval Value ≤500 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval Value &gt;500 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern</title>
        <description>Single supine blood pressure and pulse measurements meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. Systolic Blood Pressure (BP) min. &lt;90mm Hg; 2. Diastolic BP min. &lt;50mm Hg; 3. Supine pulse rate min. &lt;40 bpm, max. &gt;120 bpm.</description>
        <time_frame>From Study Day 1 up tp Study Day 10</time_frame>
        <population>All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Daily (QD)</title>
            <description>Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
          <group group_id="O2">
            <title>PF-06835919 300 mg Daily (QD)</title>
            <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern</title>
          <description>Single supine blood pressure and pulse measurements meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. Systolic Blood Pressure (BP) min. &lt;90mm Hg; 2. Diastolic BP min. &lt;50mm Hg; 3. Supine pulse rate min. &lt;40 bpm, max. &gt;120 bpm.</description>
          <population>All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic BP &lt; 90mm Hg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic BP &lt; 50mm Hg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Pulse Rate&lt;40bpm or &gt;120bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing pulse rate&lt;40bpm or &gt;140bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Summary of Maximum Plasma Concentration (Cmax) of PF-06835919 on Day 1 and Day 7</title>
        <description>Cmax was defined as maximum observed plasma concentration.</description>
        <time_frame>Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7</time_frame>
        <population>All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06835919 300 mg Daily (QD)</title>
            <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Maximum Plasma Concentration (Cmax) of PF-06835919 on Day 1 and Day 7</title>
          <description>Cmax was defined as maximum observed plasma concentration.</description>
          <population>All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.</population>
          <units>microgram per milliliter (mcg/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.39" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.49" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Summary of Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of PF-06835919 on Day 1 and Day 7</title>
        <description>AUCtau was defined as area under the plasma concentration-time curve over dosing interval.</description>
        <time_frame>Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7</time_frame>
        <population>All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06835919 300 mg Daily (QD)</title>
            <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of PF-06835919 on Day 1 and Day 7</title>
          <description>AUCtau was defined as area under the plasma concentration-time curve over dosing interval.</description>
          <population>All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.</population>
          <units>mcg*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.3" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="230.9" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Summary of Time for Maximum Observed Concentration (Tmax) of PF-06835919 on Day 1 and Day 7</title>
        <description>Tmax was defined as Time for maximum observed concentration of PF-06835919.</description>
        <time_frame>Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7</time_frame>
        <population>All participants who received at least 1 dose of PF-06835919 and who had at least 1 of the PK parameters of interest calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06835919 300 mg Daily (QD)</title>
            <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Time for Maximum Observed Concentration (Tmax) of PF-06835919 on Day 1 and Day 7</title>
          <description>Tmax was defined as Time for maximum observed concentration of PF-06835919.</description>
          <population>All participants who received at least 1 dose of PF-06835919 and who had at least 1 of the PK parameters of interest calculated.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: Tmax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.834" lower_limit="0.500" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7: Tmax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.750" lower_limit="0.500" upper_limit="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Summary of Terminal Half-life (t1/2) of PF-06835919 on Day 7</title>
        <description>t1/2 was defined as terminal half-life.</description>
        <time_frame>Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 7</time_frame>
        <population>All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06835919 300 mg Daily (QD)</title>
            <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of Terminal Half-life (t1/2) of PF-06835919 on Day 7</title>
          <description>t1/2 was defined as terminal half-life.</description>
          <population>All participants who received at least 1 dose of PF-06835919 and who have at least 1 of the PK parameters of interest calculated.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.62" spread="2.944"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Study Day 1 up to Study Day 42</time_frame>
      <desc>Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Daily (QD)</title>
          <description>Participants received matching placebo at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
        </group>
        <group group_id="E2">
          <title>PF-06835919 300 mg Daily (QD)</title>
          <description>Participants received PF-06835919 300 mg daily at approximately 0800 hours (plus or minus 2 hours), approximately 20 minutes prior to the start of breakfast on Days 1-7.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v23.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04427917
org study id: C1061010
secondary id: 2020-000218-13
secondary id: JAPANESE BRIDGING
nct id: NCT04427917
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of
      multiple oral doses of PF-06835919 in healthy adult Japanese participants.

      A total of approximately 8 healthy participants will be enrolled in this study. Participants
      will be randomized to 2 groups to receive PF-06835919 or placebo treatment with a
      randomization ratio of 3:1.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a Phase 1, randomized, double-blind, sponsor-open, placebo-controlled study in healthy adult Japanese participants.
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: double
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study
time frame: Baseline (Day 1) to follow-up (Day 42)
description: An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
measure: Number of Participants With Clinical Laboratory Findings of Potential Clinical Importance
time frame: Day 1 to Day 10
description: To determine if there were any clinically significant laboratory abnormalities, haematological (hemoglobin, hematocrit, red blood cell count, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes), clinical chemistry (blood urea nitrogen, glucose [fasting], calcium, sodium, potassium, chloride, bicarbonate, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein) and urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.
measure: Number of Participants With ECG Data of Potential Clinical Concern
time frame: Day 1 to Day 10
description: ECG endpoints (QTcF, PR and QRS) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1.maximum post-dose QTcF ≤450msec, 450 - ≤480msec, 480 - ≤500msec and >500msec; 2. PR max. ≥300ms; 3. QRS max. ≥140ms.
measure: Number of Participants/Subjects With Vital Signs Data of Potential Clinical Concern
time frame: From Study Day 1 up tp Study Day 10
description: Single supine blood pressure and pulse measurements meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. Systolic Blood Pressure (BP) min. <90mm Hg; 2. Diastolic BP min. <50mm Hg; 3. Supine pulse rate min. <40 bpm, max. >120 bpm.
measure: Summary of Maximum Plasma Concentration (Cmax) of PF-06835919 on Day 1 and Day 7
time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7
description: Cmax was defined as maximum observed plasma concentration.
measure: Summary of Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of PF-06835919 on Day 1 and Day 7
time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7
description: AUCtau was defined as area under the plasma concentration-time curve over dosing interval.
measure: Summary of Time for Maximum Observed Concentration (Tmax) of PF-06835919 on Day 1 and Day 7
time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 1 and Day 7
description: Tmax was defined as Time for maximum observed concentration of PF-06835919.
measure: Summary of Terminal Half-life (t1/2) of PF-06835919 on Day 7
time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 on Day 7
description: t1/2 was defined as terminal half-life.
arm group label: PF-06835919
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PF-06835919
description: PF-06835919 300 mg repeated doses
arm group label: PF-06835919
intervention type: Drug
intervention name: Placebo
description: Placebo repeated doses
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
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=C1061010
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.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 