<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/NCT02237742</url>
  </required_header>
  <id_info>
    <org_study_id>B7871004</org_study_id>
    <secondary_id>2014-002626-12</secondary_id>
    <nct_id>NCT02237742</nct_id>
  </id_info>
  <brief_title>A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males</brief_title>
  <official_title>A Phase 1, Non-Randomized, Open-Label, Single-Dose, Single Period Study With Non-Pharmacologically Active Dose Of Pf-06427878 To Characterize Pharmacokinetics Following Intravenous Administration In Healthy, Adult, Male 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>
      To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30&#xD;
      minutes to healthy, adult, males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)</measure>
    <time_frame>Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Terminal Elimination Half Life (t1/2)</measure>
    <time_frame>Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Systemic Clearance (CL)</measure>
    <time_frame>Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Volume of Distribution at Steady State (Vss)</measure>
    <time_frame>Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)</measure>
    <time_frame>Day 1 Hr 0 to 12.5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%)</measure>
    <time_frame>Day 1 Hr 0 to 12.5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance (CLr)</measure>
    <time_frame>Day 1 Hr 0 to 12.5</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>PF-06427878</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06427878</intervention_name>
    <description>Intravenous, 100 micrograms, single dose, 30 minute infusion</description>
    <arm_group_label>PF-06427878</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male subjects between 18-55 years of age&#xD;
&#xD;
          2. BMI of 17.5-30.5 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of drug or alcohol abuse within 2 years of screening&#xD;
&#xD;
          2. Subjects without suitable veins for multiple venipuncture/cannulation&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Quotient Clinical Ltd</name>
      <address>
        <city>Ruddington</city>
        <state>Nottingham</state>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>November 12, 2018</last_update_submitted>
  <last_update_submitted_qc>November 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02237742
org study id: B7871004
secondary id: 2014-002626-12
nct id: NCT02237742
lead sponsor: 
has dmc: No
To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30
      minutes to healthy, adult, males.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)
time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)
time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Plasma Terminal Elimination Half Life (t1/2)
time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Plasma Systemic Clearance (CL)
time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Plasma Volume of Distribution at Steady State (Vss)
time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
measure: Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)
time frame: Day 1 Hr 0 to 12.5
measure: Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%)
time frame: Day 1 Hr 0 to 12.5
measure: Renal clearance (CLr)
time frame: Day 1 Hr 0 to 12.5
arm group label: PF-06427878
arm group type: Experimental
intervention type: Drug
intervention name: PF-06427878
description: Intravenous, 100 micrograms, single dose, 30 minute infusion
arm group label: PF-06427878
criteria: 
gender: Male
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 Kingdom
responsible party type: Sponsor