Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)

Part of paid clinical trials in Miami, Florida.

Sponsor
Ensysce Biosciences
Study ID
NCT06500793
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Volunteer
  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • PF614 capsule — DRUG
    PF614 capsules (25-100 mg)
  • Nafamostat Mesylate — DRUG
    Nafamostat IR/ER solution/beads/powder (total 1-25 mg)

Study Details

A single 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.

Key Dates

Start date
Nov 24, 2024
Status verified
May 2026
Primary completion
Dec 22, 2026
Completion
Apr 28, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PF614 capsule with naltrexone HCl
    PF614 is an oxycodone prodrug. Part 1 doses = 100, 300 and up to 500 mg. Subjects will receive single daily doses at 5-14 days apart. Naltrexone, 50 mg Oral (Day -1, Day 1 and Day 2). All subjects will receive naltrexone block
  • Experimental: PF614 capsule concomitantly with nafamostat and naltrexone HCl
    PF614 is an oxycodone prodrug. Part 1 doses = 100, 300 and up to 500 mg. Nafamostat Mesylate is a trypsin inhibitor that blocks PF614 activation. Nafamostat IR solution (0.75 - XX mg); Nafamostat ER beads in capsule formulation (0.25 - YY mg) Naltrexone, 50 mg Oral (Day -1, Day 1 and Day 2). All subjects will receive naltrexone block

Primary Outcome Measure

Pharmacokinetic Tmax [Time to Maximum Plasma Concentration] [ Time Frame: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Quotient SciencesMiamiFlorida33126
Claire Swann
[email protected]
Jeffrey Levy, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
Quotient Sciences· Miami, FL

Related Studies