A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users
Condition: Recreational Drug Use
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, double-blind, placebo- and active-controlled, 5-way crossover
      study to evaluate the abuse potential, safety and pharmacokinetics of orally administered
      PF614 relative to oxycodone IR (immediate-release) tablets and placebo.
    

Detailed description: 
      The study will consist of 4 phases: Screening, Qualification, Treatment and Follow-up.

        1. Screening Visit (Visit 1) The Screening Phase will be completed as an outpatient visit
           within 28 days of the Qualification Phase and will consist of a standard medical screen.

        2. Qualification Phase (Visit 2) Within 28 days of a standard medical screening, eligible
           subjects will return to the clinical site as inpatients to complete the Qualification
           Phase (Visit 2). Upon admission to the clinical site, subjects will be interviewed and
           assessed for continued eligibility for the study. Subjects will check into the inpatient
           facility on Day -1.

           The Qualification Phase will include a Naloxone Challenge Test to confirm that subjects
           are not opioid dependent and a Drug Discrimination Test to ensure that subjects can
           distinguish between the active control (oxycodone hydrochloride (HCl) immediate-release
           tablets 40 mg) and placebo.

           Eligible subjects who meet Qualification Criteria will remain as inpatient until the
           Treatment Phase. Subjects who do not meet Qualification Criteria will be discharged
           after all post-dose assessments have been performed after the last study drug
           administration. The last study drug administration in the Qualification Phase and the
           first study drug administration of the Treatment Phase will be separated by a washout
           period of approximately 72 hours.

        3. Treatment Phase (Visit 2-Continued)

           The Treatment Phase will consist of 5 treatment periods. Subjects will receive each of
           the following 5 treatments (1 per treatment period) in a randomized, double-blind,
           crossover manner, following a fasting period of at least 8 hours:

             -  Treatment A: PF614 50 mg

             -  Treatment B: PF614 100 mg

             -  Treatment C: PF614 200 mg

             -  Treatment D: Oxycodone IR 40 mg

             -  Treatment E: Placebo

           Pharmacodynamic, pharmacokinetic and safety assessments will be conducted prior to
           dosing and for 24 hours after each study drug administration. Each study drug
           administration will be separated by a washout interval of approximately 120 hours. All
           subjects will remain in clinic for the duration of the Treatment Phase. Subjects will be
           discharged after all post-dose assessments are performed at End of Treatment (EOT), if
           considered medically suitable for discharge by the investigator.

        4. Follow-up Visit (Visit 3) A follow-up visit will be conducted at 8 days (±2 days) after
           last study drug administration in the Treatment Phase or after early termination
           (EOS/ET) from the study.
    

Intervention name(s): PF614; Oxycodone Hydrochloride 40 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF614 capsules (50 mg or 100 mg); Oral 20 mg tablets (two each); Placebo to match PF614 capsules will be provided by the sponsor.
Other intervention name(s): Oxycodone prodrug; Oxycodone hydrochloride (HCl) immediate-release (IR) tablets, 40 mg; Roxicodone or generic equivalent, 40 mg; Placebo capsules
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The Treatment Phase will consist of 5 treatment periods. Subjects will receive each of the following 5 treatments (1 per treatment period) in a randomized, double-blind, crossover manner, following a fasting period of at least 8 hours. Pharmacodynamic, pharmacokinetic and safety assessments will be conducted prior to dosing and for 24 hours after each study drug administration. Each study drug administration will be separated by a washout interval of approximately 120 hours. All subjects will remain in clinic for the duration of the Treatment Phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-dependent