Study of PF614 Compared to OxyContin® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable
      to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and
      pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.
    

Detailed description: 
      This will be a Phase 1 randomized, single-center, SAD study in 6 cohorts of 8 healthy male
      and/or female subjects each (Cohorts 1-6) plus 16 enrolled healthy male and/or female
      subjects (Cohort 7). The study will evaluate the safety and PK of PF614 and the PK of
      oxycodone at doses sufficient to characterize the extent to which plasma oxycodone is
      produced and maintained following oral ingestion of PF614. The PK of the prodrug fragments
      will also be evaluated. There will be a parallel study arm in each cohort dosed that will use
      oral OxyContin® as an active comparator. Subjects will receive PF614 (n=6) or OxyContin as
      comparator (n=2) orally in the fasted state. In addition, all subjects starting with Cohort
      1C will receive naltrexone at 14 hours pre-dose, 2 hours pre-dose and 10 hours post dose to
      block the effects of oxycodone. The starting dose for administration of PF614 will be 15 mg.
      The lowest available dose of OxyContin, 10 mg, will be used as the comparator in the first
      cohort. PK assessments will be conducted after each cohort to compare the oxycodone area
      under curve (AUC) of PF614 and OxyContin to determine the most appropriate dose for the
      subsequent cohorts. In Cohort 6 (fed subjects), all subjects (n=8) will receive the same
      PF614 and naltrexone doses as administered in Cohort 5 to evaluate the PK and safety of PF614
      in fed vs. fasted state. Subjects in Cohort 6 will receive a Food and Drug
      Administration-defined high-fat, high-calorie breakfast 30 minutes prior to study drug
      administration. In Cohort 7, treatments will be administered in a cross-over study design
      across 2 periods. All subjects (n=16 enrolled; estimated n=12 completers) will receive the
      same PF614 dose as administered in Cohort 1 (15 mg) with and without naltrexone to evaluate
      the potential effect of naltrexone on the plasma PK of PF614 and oxycodone. Cohort 7, Period
      1 subjects may return for their cross-over treatments in Period 2 after a minimum of 12 days
      after receiving their initial Cohort 7 doses.
    

Intervention name(s): PF614; Oxycodone extended-release; Naltrexone Hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF614 is an oxycodone prodrug; Oxycodone extended-release is the comparator drug; Naltrexone HCl tablets, 50 mg, will be used to block high dose opioid effects in healthy volunteers
Other intervention name(s): PRF06104; OxyContin; ReVia
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prodrug; PF614; oxycodone extended-release; oral