<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/NCT02966860</url>
  </required_header>
  <id_info>
    <org_study_id>MNK15141038</org_study_id>
    <nct_id>NCT02966860</nct_id>
  </id_info>
  <brief_title>Single-Dose PK Study of an Oxycodone/Acetaminophen Solution in Healthy Subjects</brief_title>
  <official_title>A Single-Dose Study Evaluating the Oral Pharmacokinetics of an Oxycodone/Acetaminophen Solution in Healthy Subjects Under Fasted Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mallinckrodt</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mallinckrodt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects&#xD;
      under fasted conditions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, single-dose, single-center study evaluating the oral PK of an oxycodone/apap&#xD;
      solutions in healthy subjects under fasted conditions&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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 concentration-time curve from time 0 to the time of the last quantifiable sample (AUC0-t)</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Observed maximum plasma concentration</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Observed time to maximum plasma concentration</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent elimination half-life</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Oxycodone and acetaminophen (OC/APAP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single 15 mL dose of oral solution of OC/APAP (total dose 15 mg oxycodone/975 mg acetaminophen)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral solution OC/APAP</intervention_name>
    <arm_group_label>Oxycodone and acetaminophen (OC/APAP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be adequately informed and understands the nature and risks of the study&#xD;
             and must be able to provide a signature and date on the informed consent form (ICF).&#xD;
&#xD;
          -  Subjects must have a health status of &quot;healthy&quot; assessed by the investigator, defined&#xD;
             as no clinically significant deviation from normal in medical history, physical&#xD;
             examination, and clinical laboratory determinations.&#xD;
&#xD;
          -  Subjects must be males or nonpregnant, nonlactating females, between 18 and 55 years&#xD;
             of age (inclusive) at time of the Screening Visit.&#xD;
&#xD;
          -  Subjects must have a body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m² with a minimum&#xD;
             weight of 110 pounds for females and 130 pounds for males at the Screening Visit. The&#xD;
             BMI will be calculated using the standard formula of weight (kg)/(height [m])2.&#xD;
&#xD;
          -  Female subjects must have a negative serum pregnancy test at the Screening Visit and&#xD;
             check-in to the study site. All female subjects who are biologically capable of having&#xD;
             children must agree and commit to the use of 2 acceptable methods of birth control,&#xD;
             defined as nonhormonal forms of contraception, condoms or diaphragms with spermicidal&#xD;
             foam 14 days prior to check-in to the study site and for the duration of study&#xD;
             participation. Unacceptable methods of birth control include abstinence,&#xD;
             hormone-containing intrauterine devices, uterine ablation, hormonal forms of&#xD;
             contraception, rhythm, and withdrawal methods. Female subjects who are not&#xD;
             biologically capable of having children are defined as postmenopausal female subjects&#xD;
             who have been amenorrheic for at least 12 consecutive months prior to the Screening&#xD;
             Visit or are surgically sterile.&#xD;
&#xD;
          -  Male subjects with reproductive potential must agree to use an acceptable method of&#xD;
             contraception for the duration of the study (surgical sterilization [vasectomy] or&#xD;
             condom with spermicide).&#xD;
&#xD;
          -  Subjects must be able to communicate effectively with study personnel.&#xD;
&#xD;
          -  Subjects must be able and willing to follow all protocol requirements and study&#xD;
             restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A subjects is ineligible for the study if he or she meets any of the following&#xD;
             criteria at the Screening Visit or at check-in to the study site:&#xD;
&#xD;
          -  Subject is from a vulnerable population, as defined by the Code of Federal Regulations&#xD;
             Title 45, Part 46, Section 46.111(b), including but not limited to employees&#xD;
             (temporary, part-time, full time, etc.) or a family member of the research staff&#xD;
             conducting the study, or of the sponsor, or of the clinical research organization, or&#xD;
             of the institutional review board (IRB).&#xD;
&#xD;
          -  Subject has a history of any drug allergy, hypersensitivity, or intolerance to any&#xD;
             opioids, APAP, or naltrexone which, in the opinion of the investigator, would place&#xD;
             the subject at particular risk and compromise the safety of the subject in the study.&#xD;
&#xD;
          -  Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B&#xD;
             (surface antigen), or hepatitis C virus antibody.&#xD;
&#xD;
          -  Subject has a thyroid-stimulating hormone (TSH) value that is outside the reference&#xD;
             range at the Screening Visit.&#xD;
&#xD;
          -  Subject has donated or had significant loss of whole blood (480 mL or more) within 30&#xD;
             days, or plasma within 14 days, prior to the Screening Visit or plans to donate blood&#xD;
             or plasma while enrolled in this study.&#xD;
&#xD;
          -  Subject has smoked or used nicotine-containing products 6 months prior to the&#xD;
             Screening Visit.&#xD;
&#xD;
          -  Subject has current or recent (within 2 years of the Screening Visit) drug or alcohol&#xD;
             abuse, as defined in Diagnostic and Statistical Manual of Mental Disorders Fifth&#xD;
             Edition, Diagnostic Criteria for Drug and Alcohol Abuse.&#xD;
&#xD;
          -  Subject has current or recent (within 3 months of the Screening Visit)&#xD;
             gastrointestinal (GI) disease (including, but not limited to, peptic ulcer,&#xD;
             diverticulitis, bowel obstructions, adhesions, malabsorption, paralytic ileus,&#xD;
             gastritis, or diarrhea) or any GI surgery that could impact the absorption of study&#xD;
             drug (including, but not limited to, cholecystectomy and gastric bypass or gastric&#xD;
             band surgery).&#xD;
&#xD;
          -  Subject had any major surgery within 3 months prior to the Screening Visit.&#xD;
&#xD;
          -  Subject has a history, or laboratory evidence of, a bleeding or clotting disorder or&#xD;
             condition.&#xD;
&#xD;
          -  Subject is unable to tolerate venipuncture and/or venous access.&#xD;
&#xD;
          -  Subject has any medical, psychiatric and/or social reason for exclusion, as determined&#xD;
             by the investigator.&#xD;
&#xD;
          -  Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates,&#xD;
             cannabinoids, benzodiazepines, cocaine, amphetamine), cotinine, or alcohol at the&#xD;
             Screening Visit or at check-in to the study site.&#xD;
&#xD;
          -  Subject used any other investigational medicinal product (study drug) within 30 days&#xD;
             prior to the Screening Visit and throughout the duration of the study or plans to&#xD;
             participate in another clinical study while concurrently enrolled in this study.&#xD;
&#xD;
          -  Subject has taken prescription drugs or over-the-counter (OTC) medications, vitamins,&#xD;
             minerals, or dietary/herbal supplements (including grapefruit juice and&#xD;
             grapefruit-containing products, St. John's wort and St. John's wort-containing&#xD;
             products) within 14 days prior to check-in to the study site and throughout the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Subject has a history of conditions which might be specifically contraindicated or&#xD;
             require caution to be used during the administration of any drug in the study.&#xD;
&#xD;
          -  Subject presents with a history of acute illness within 14 days prior to check-in to&#xD;
             the study site and throughout the duration of the study.&#xD;
&#xD;
          -  Subject has an electrocardiogram (ECG) parameter (confirmed by repeat evaluation)&#xD;
             outside the following limits: PR ≥ 210 ms, QRS ≥ 120 ms, QT ≥ 500 ms; QT interval&#xD;
             corrected for heart rate incorporating Bazett's formula (QTcB) ≥ 450 ms.&#xD;
&#xD;
          -  Subject has other clinically significant ECG abnormalities, as assessed by the&#xD;
             investigator.&#xD;
&#xD;
          -  Subject has an oxygen saturation of &lt; 95%.&#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>
  <location>
    <facility>
      <name>PPD Phase 1 Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 6, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>April 4, 2017</last_update_submitted>
  <last_update_submitted_qc>April 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</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/NCT02966860
org study id: MNK15141038
nct id: NCT02966860
lead sponsor: 
has dmc: No
A single-dose study evaluating the oral PK of an oxycodone/apap solution in healthy subjects
      under fasted conditions
An open-label, single-dose, single-center study evaluating the oral PK of an oxycodone/apap
      solutions in healthy subjects under fasted conditions
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under the concentration-time curve from time 0 to the time of the last quantifiable sample (AUC0-t)
time frame: 24 hours
measure: Observed maximum plasma concentration
time frame: 24 hours
measure: Observed time to maximum plasma concentration
time frame: 24 hours
measure: Apparent elimination half-life
time frame: 24 hours
arm group label: Oxycodone and acetaminophen (OC/APAP)
arm group type: Experimental
description: Single 15 mL dose of oral solution of OC/APAP (total dose 15 mg oxycodone/975 mg acetaminophen)
intervention type: Drug
intervention name: Oral solution OC/APAP
arm group label: Oxycodone and acetaminophen (OC/APAP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor