<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/NCT01677039</url>
  </required_header>
  <id_info>
    <org_study_id>B4531004</org_study_id>
    <nct_id>NCT01677039</nct_id>
  </id_info>
  <brief_title>Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation</brief_title>
  <official_title>An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers</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>
      The study is designed to test whether or not the rate and extent of absorption of oxycodone&#xD;
      from a proprietary controlled-release formulation is significantly affected by&#xD;
      co-administration of alcohol compared with controlled conditions (when the formulation is&#xD;
      administered with water). The primary pharmacokinetic parameters are the peak concentration&#xD;
      of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area&#xD;
      under the plasma concentration-time curve (AUC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Maximum observed oxycodone concentration in plasma (Cmax)</measure>
    <time_frame>hours after dosing</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the oxycodone concentration versus time curve (AUC)</measure>
    <time_frame>hours after dosing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time-to-peak concentration (Tmax)</measure>
    <time_frame>hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>half-life of drug</measure>
    <time_frame>hours after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs and adverse events</measure>
    <time_frame>hours after dosing</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Treatment A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test formulation administered with water</intervention_name>
    <description>single dose of 20 mg of test formulation with 240 mL of water</description>
    <arm_group_label>Treatment A</arm_group_label>
    <other_name>ALO-02 20 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test formulation administered with 20% ethanol</intervention_name>
    <description>single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water</description>
    <arm_group_label>Treatment B</arm_group_label>
    <other_name>ALO-02 20 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Test formulation administered with 40% ethanol</intervention_name>
    <description>single dose of 20 mg of test formulation with 240 mL of 40% ethanol</description>
    <arm_group_label>Treatment C</arm_group_label>
    <other_name>ALO-02 20 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
          -  history of moderate alcohol consumption&#xD;
&#xD;
          -  total body weight exceeding 64 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of clinically significant disease&#xD;
&#xD;
          -  history of sleep apnea&#xD;
&#xD;
          -  any condition affecting drug absorption&#xD;
&#xD;
          -  pregnant or nursing female subjects&#xD;
&#xD;
          -  history of allergy or hypersensitivity to either oxycodone or naltrexone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 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=B4531004&amp;StudyName=Study%20to%20Determine%20the%20Effects%20of%20Co-Administration%20of%20Alcohol%20on%20the%20Absorption%20of%20Oxycodone%20from%20a%20Proprietary%20Controlled-Release%20Formul</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>December 10, 2012</last_update_submitted>
  <last_update_submitted_qc>December 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bioavailability</keyword>
  <keyword>oxycodone</keyword>
  <keyword>ethanol interaction</keyword>
  <keyword>healthy volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</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/NCT01677039
org study id: B4531004
nct id: NCT01677039
lead sponsor: 
has dmc: No
The study is designed to test whether or not the rate and extent of absorption of oxycodone
      from a proprietary controlled-release formulation is significantly affected by
      co-administration of alcohol compared with controlled conditions (when the formulation is
      administered with water). The primary pharmacokinetic parameters are the peak concentration
      of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area
      under the plasma concentration-time curve (AUC).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Maximum observed oxycodone concentration in plasma (Cmax)
time frame: hours after dosing
measure: Area under the oxycodone concentration versus time curve (AUC)
time frame: hours after dosing
measure: Time-to-peak concentration (Tmax)
time frame: hours after dosing
measure: half-life of drug
time frame: hours after dosing
measure: Vital signs and adverse events
time frame: hours after dosing
arm group label: Treatment A
arm group type: Active Comparator
arm group label: Treatment B
arm group type: Experimental
arm group label: Treatment C
arm group type: Experimental
intervention type: Drug
intervention name: Test formulation administered with water
description: single dose of 20 mg of test formulation with 240 mL of water
arm group label: Treatment A
other name: ALO-02 20 mg
intervention type: Drug
intervention name: Test formulation administered with 20% ethanol
description: single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water
arm group label: Treatment B
other name: ALO-02 20 mg
intervention type: Drug
intervention name: Test formulation administered with 40% ethanol
description: single dose of 20 mg of test formulation with 240 mL of 40% ethanol
arm group label: Treatment C
other name: ALO-02 20 mg
criteria: 
gender: All
minimum age: 21 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=B4531004&StudyName=Study%20to%20Determine%20the%20Effects%20of%20Co-Administration%20of%20Alcohol%20on%20the%20Absorption%20of%20Oxycodone%20from%20a%20Proprietary%20Controlled-Release%20Formul
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Ethanol