Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)

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.