<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/NCT01717027</url>
  </required_header>
  <id_info>
    <org_study_id>B4501034</org_study_id>
    <nct_id>NCT01717027</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers</brief_title>
  <official_title>Open Label, Single Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted Conditions In Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pain Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PainT</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To estimate the pharmacokinetics and relative bioavailability of oxycodone after&#xD;
      administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions&#xD;
      and after chewing under fasted conditions in healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will estimate the pharmacokinetics and relative bioavailability of oxycodone&#xD;
      following oral administration of single 40 mg doses of PF-00345439 Formulations J and K&#xD;
      compared with the reference PF-00345439 Formulation A, all taken whole and under fed&#xD;
      conditions in healthy volunteers.&#xD;
&#xD;
      In addition, the study will estimate the pharmacokinetics and relative bioavailability of&#xD;
      oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or&#xD;
      K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to that&#xD;
      taken whole in the fed state in healthy volunteers, and assess the single-dose safety and&#xD;
      tolerability of oxycodone inPF-00345439 formulations in healthy volunteers when administered&#xD;
      under a naltrexone block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.</measure>
    <time_frame>0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit</measure>
    <time_frame>0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.</measure>
    <time_frame>0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life of oxycodone, as data permit.</measure>
    <time_frame>0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration at time 24 hours (C24) of oxycodone, as data permit.</measure>
    <time_frame>0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>One capsule of 40 mg PF-00345439 Formulation A, single dose, taken whole and under fed conditions</description>
    <arm_group_label>Treatment A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions</description>
    <arm_group_label>Treatment B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions</description>
    <arm_group_label>Treatment C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted conditions</description>
    <arm_group_label>Treatment D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and/or female subjects between 18 and 55 years of age (inclusive).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant disease.&#xD;
&#xD;
          -  Positive urine drug test&#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 Investigational Site</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=B4501034&amp;StudyName=Pharmacokinetics%20And%20Relative%20Bioavailability%20Study%20Of%20Oxycodone%20in%20Healthy%20Volunteers%0A</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>August 28, 2015</last_update_submitted>
  <last_update_submitted_qc>August 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacokinetics</keyword>
  <keyword>bioavailability</keyword>
  <keyword>oxycodone</keyword>
  <keyword>management of moderate to severe pain</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01717027
org study id: B4501034
nct id: NCT01717027
lead sponsor: 
has dmc: No
To estimate the pharmacokinetics and relative bioavailability of oxycodone after
      administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions
      and after chewing under fasted conditions in healthy volunteers
This study will estimate the pharmacokinetics and relative bioavailability of oxycodone
      following oral administration of single 40 mg doses of PF-00345439 Formulations J and K
      compared with the reference PF-00345439 Formulation A, all taken whole and under fed
      conditions in healthy volunteers.

      In addition, the study will estimate the pharmacokinetics and relative bioavailability of
      oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or
      K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to that
      taken whole in the fed state in healthy volunteers, and assess the single-dose safety and
      tolerability of oxycodone inPF-00345439 formulations in healthy volunteers when administered
      under a naltrexone block.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.
time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit
time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.
time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
measure: Plasma Decay Half-Life of oxycodone, as data permit.
time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
measure: Concentration at time 24 hours (C24) of oxycodone, as data permit.
time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose
arm group label: Treatment A
arm group type: Experimental
description: Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
arm group label: Treatment B
arm group type: Experimental
description: Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
arm group label: Treatment C
arm group type: Experimental
description: Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
arm group label: Treatment D
arm group type: Experimental
description: Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
intervention type: Drug
intervention name: Oxycodone
description: One capsule of 40 mg PF-00345439 Formulation A, single dose, taken whole and under fed conditions
arm group label: Treatment A
intervention type: Drug
intervention name: Oxycodone
description: One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions
arm group label: Treatment B
intervention type: Drug
intervention name: Oxycodone
description: One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions
arm group label: Treatment C
intervention type: Drug
intervention name: Oxycodone
description: One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted conditions
arm group label: Treatment D
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=B4501034&StudyName=Pharmacokinetics%20And%20Relative%20Bioavailability%20Study%20Of%20Oxycodone%20in%20Healthy%20Volunteers%0A
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Oxycodone