<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/NCT03232905</url>
  </required_header>
  <id_info>
    <org_study_id>B7981008</org_study_id>
    <secondary_id>2017-001298-17</secondary_id>
    <nct_id>NCT03232905</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetic Study of PF-06651600 in Japanese Healthy Volunteers</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Third-party Open, Placebo-controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics After Multiple Oral Doses Of Pf-06651600 In Healthy Japanese Subjects</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 study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of&#xD;
      inflammatory bowel disease. The goal of the study is to assess the safety, tolerability,&#xD;
      pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600&#xD;
      in Japanese healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">November 22, 2017</completion_date>
  <primary_completion_date type="Actual">October 27, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs</measure>
    <time_frame>Baseline up to Day 45</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate)</measure>
    <time_frame>Baseline, 1 hour post-dose on Day 1 and 10</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)</measure>
    <time_frame>Baseline, Day 1, 10, 12 and 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Change From Baseline in Physical Examinations</measure>
    <time_frame>Baseline up to Day 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>Baseline up to Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10</measure>
    <time_frame>pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PF-06651600</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple ascending doses of PF-06651600</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multiple ascending doses of Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06651600</intervention_name>
    <description>PF-06651600 will be administered as tablet</description>
    <arm_group_label>PF-06651600</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo will be administered as tablet</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have four Japanese grandparents who were born in Japan.&#xD;
&#xD;
          -  Healthy male subjects and/or female subjects of non-childbearing potential between the&#xD;
             ages of 18 and 55 years, inclusive&#xD;
&#xD;
          -  No evidence of active or latent or inadequately treated infection with Mycobacterium&#xD;
             tuberculosis (TB)&#xD;
&#xD;
          -  BMI of 17.5 to 27.5 kg/m2; and a total body weight &gt;50 kg (110 lbs).&#xD;
&#xD;
          -  Evidence of personally signed and dated informed consent document.&#xD;
&#xD;
          -  Willing and able to comply with scheduled visits, treatment plan, lab tests and other&#xD;
             study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.&#xD;
&#xD;
          -  Males of childbearing potential who are unwilling or unable to use a highly effective&#xD;
             method of contraception as outlined in this protocol for the duration of the study and&#xD;
             for at least 28 days after the last dose of investigational product&#xD;
&#xD;
          -  Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.&#xD;
&#xD;
          -  History of regular alcohol consumption exceeding 14 drinks/week for females or 21&#xD;
             drinks/week for males.&#xD;
&#xD;
          -  Screening blood pressure &gt;140/90 mm Hg.&#xD;
&#xD;
          -  Screening laboratory abnormalities as defined by the protocol.&#xD;
&#xD;
          -  Unwilling or unable to comply with the Lifestyle Guidelines as defined by the&#xD;
             protocol.&#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>Pfizer Clinical Research Unit</name>
      <address>
        <city>Brussels</city>
        <zip>B-1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981008&amp;StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Third-party+Open%2C+Placebo-controlled+Study+To+Evaluate+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+After+Multiple+Oral+Doses+Of+Pf-06651600+In+Healthy+Japanese+Subjects</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03232905
org study id: B7981008
secondary id: 2017-001298-17
nct id: NCT03232905
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of
      inflammatory bowel disease. The goal of the study is to assess the safety, tolerability,
      pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600
      in Japanese healthy volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
time frame: Baseline up to Day 45
measure: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS interval, QT Interval, QTC Interval, heart rate)
time frame: Baseline, 1 hour post-dose on Day 1 and 10
measure: Change From Baseline in Vital Signs (Blood Pressure, Pulse Rate, Oral Temperature)
time frame: Baseline, Day 1, 10, 12 and 28
measure: Number of Participants With Change From Baseline in Physical Examinations
time frame: Baseline up to Day 28
measure: Number of Participants With Laboratory Abnormalities
time frame: Baseline up to Day 28
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 1
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06651600 at Day 10
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 1
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06651600 at Day 10
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06651600 at Day 1
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06651600 at Day 1
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 1
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06651600 at Day 10
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 1
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 1
measure: Plasma Decay Half-Life (t1/2) of PF-06651600 at Day 10
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Observed Accumulation Ratio (Rac) on AUCtau for PF-06651600 at Day 10
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: Observed Accumulation Ratio on Cmax (RacCmax) for PF-06651600 at Day 10
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
measure: MinimumObserved Plasma Concentration (Cmin) of PF-06651600 at Day 10
time frame: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hour post-dose on Day 10
arm group label: PF-06651600
arm group type: Experimental
description: Multiple ascending doses of PF-06651600
arm group label: Placebo
arm group type: Placebo Comparator
description: Multiple ascending doses of Placebo
intervention type: Drug
intervention name: PF-06651600
description: PF-06651600 will be administered as tablet
arm group label: PF-06651600
intervention type: Drug
intervention name: Placebo
description: Matching placebo will be administered as tablet
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://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7981008&StudyName=A+Phase+1%2C+Randomized%2C+Double-blind%2C+Third-party+Open%2C+Placebo-controlled+Study+To+Evaluate+The+Safety%2C+Tolerability%2C+And+Pharmacokinetics+After+Multiple+Oral+Doses+Of+Pf-06651600+In+Healthy+Japanese+Subjects
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
sharing ipd: No
ipd description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests