Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
NCT Number: NCT06500793
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pharmacokinetics
Interventions: DRUG: PF614 capsule|DRUG: Nafamostat Mesylate
Sponsor: Ensysce Biosciences
Collaborators: Quotient Sciences
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-06
Locations: Quotient Sciences, Miami, Florida, 33126, United States

Summary:
A single and multiple-dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.

Primary Outcome Measures: Pharmacokinetic Tmax [Time to Maximum Plasma Concentration], Time to maximum observed concentrations of oxycodone following administration of PF614 alone and with nafamostat, Parts 1 & 2 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. Part 3 (PF614 BID doses): Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; Days 2-3 (predose); Day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)|Pharmacokinetic Cmax [Maximum Plasma Concentration], Maximum (peak) observed concentration of oxycodone following administration of PF614 alone and with nafamostat, Parts 1 & 2 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. Part 3 (PF614 BID doses): Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; Days 2-3 (predose); Day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)|Pharmacokinetic C24 [Plasma concentration at 24 hours], Concentration of oxycodone at 24 hours post-dose following administration of PF614 alone and with nafamostat, Parts 1 & 2 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. Part 3 (PF614 BID doses): Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; Days 2-3 (predose); Day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)|Pharmacokinetic AUC(0-last) [Area Under the Curve], Area under the concentration-time curve from time 0 to the time of last measurable concentrations of oxycodone following administration of PF614 alone and with nafamostat, Parts 1 & 2 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. Part 3 (PF614 BID doses): Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; Days 2-3 (predose); Day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)|Pharmacokinetic AUC(0-inf) [Area Under the Curve], Area under the concentration-time curve from time 0 extrapolated to time-infinity of oxycodone following administration of PF614 alone and with nafamostat, Parts 1 & 2 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. Part 3 (PF614 BID doses): Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; Days 2-3 (predose); Day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)|Pharmacokinetic T1/2 [Half-life], Terminal elimination half-life concentrations of oxycodone following administration of PF614 alone and with nafamostat, Parts 1 & 2 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. Part 3 (PF614 BID doses): Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 12 hours; Days 2-3 (predose); Day 5 (predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours)
Secondary Outcome Measures: Incidence of Treatment-Emergent Adverse Effects [Safety and Tolerability], Adverse events (AEs), Significant Adverse Events (SAEs), AEs leading to discontinuation, 30 Days