<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/NCT02208284</url>
  </required_header>
  <id_info>
    <org_study_id>B7871001</org_study_id>
    <nct_id>NCT02208284</nct_id>
  </id_info>
  <brief_title>A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06427878 Co-administered With Meal In Healthy Adult 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary&#xD;
      purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single&#xD;
      oral doses of PF-06427878 in healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of adverse events (AEs).</measure>
    <time_frame>0-48 h post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of clinical laboratory tests.</measure>
    <time_frame>0-48 h post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of vital signs (including blood pressure and pulse rate).</measure>
    <time_frame>0-48 h post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).</measure>
    <time_frame>0-48 h post dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose</time_frame>
    <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose</time_frame>
    <description>AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) for PF-06427878</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Oral Clearance (CL/F) for PF-06427878</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) for PF-06427878</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) for PF-06427878</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cohort 1-PF-06427878 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2-PF-06427878 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3-PF-06427878 or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06427878</intervention_name>
    <description>PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.</description>
    <arm_group_label>Cohort 1-PF-06427878 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.</description>
    <arm_group_label>Cohort 1-PF-06427878 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06427878</intervention_name>
    <description>PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.</description>
    <arm_group_label>Cohort 2-PF-06427878 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.</description>
    <arm_group_label>Cohort 2-PF-06427878 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06427878</intervention_name>
    <description>PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.</description>
    <arm_group_label>Cohort 3-PF-06427878 or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.</description>
    <arm_group_label>Cohort 3-PF-06427878 or placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects of non childbearing potential.&#xD;
&#xD;
          -  Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight &gt;50 kg&#xD;
&#xD;
          -  Subjects with fasting TG level of &gt;=90 mg/dL and &lt;=500 mg/dL following an overnight&#xD;
             fast&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies at time of dosing).&#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>New Haven Clinical Research Unit</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7871001&amp;StudyName=A%20Single%20Oral%20Dose%20Study%20Of%20PF-06427878%20In%20Healthy%20Adult%20Subjects%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>March 3, 2015</last_update_submitted>
  <last_update_submitted_qc>March 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Single Ascending Dose</keyword>
  <keyword>healthy subjects</keyword>
  <keyword>Hyperlipidemia</keyword>
  <keyword>Lipid Metabolism Disorders</keyword>
  <keyword>Metabolic Diseases</keyword>
  <!-- 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/NCT02208284
org study id: B7871001
nct id: NCT02208284
lead sponsor: 
has dmc: No
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary
      purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single
      oral doses of PF-06427878 in healthy adult subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Investigator)
measure: Assessment of adverse events (AEs).
time frame: 0-48 h post dose
measure: Assessment of clinical laboratory tests.
time frame: 0-48 h post dose
measure: Assessment of vital signs (including blood pressure and pulse rate).
time frame: 0-48 h post dose
measure: Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
time frame: 0-48 h post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
description: AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
measure: Apparent Oral Clearance (CL/F) for PF-06427878
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure: Apparent Volume of Distribution (Vz/F) for PF-06427878
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
measure: Plasma Decay Half-Life (t1/2) for PF-06427878
time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
arm group label: Cohort 1-PF-06427878 or placebo
arm group type: Experimental
description: Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
arm group label: Cohort 2-PF-06427878 or placebo
arm group type: Experimental
description: Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
arm group label: Cohort 3-PF-06427878 or placebo
arm group type: Experimental
description: Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
intervention type: Drug
intervention name: PF-06427878
description: PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
arm group label: Cohort 1-PF-06427878 or placebo
intervention type: Drug
intervention name: Placebo
description: PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
arm group label: Cohort 1-PF-06427878 or placebo
intervention type: Drug
intervention name: PF-06427878
description: PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
arm group label: Cohort 2-PF-06427878 or placebo
intervention type: Drug
intervention name: Placebo
description: PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
arm group label: Cohort 2-PF-06427878 or placebo
intervention type: Drug
intervention name: PF-06427878
description: PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
arm group label: Cohort 3-PF-06427878 or placebo
intervention type: Drug
intervention name: Placebo
description: PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
arm group label: Cohort 3-PF-06427878 or 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: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7871001&StudyName=A%20Single%20Oral%20Dose%20Study%20Of%20PF-06427878%20In%20Healthy%20Adult%20Subjects%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor