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
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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

First listed
Jul 15, 2024
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)

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Quotient Sciences· Miami, FL

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