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

NCT06500793 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-06

No results posted yet for this study

Summary

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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

PF614 capsule

PF614 capsules (25-100 mg)

DRUG

Nafamostat Mesylate

Nafamostat IR/ER solution/beads (total 1-10 mg)

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Ensysce Biosciences

    lead INDUSTRY

Principal Investigators

  • Jeffrey Levy, MD, PhD · Medical Director, Quotient Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-24
Primary Completion
2026-07-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06500793 on ClinicalTrials.gov