Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)

NCT06629402 | Completed Phase 2 FDA Drug

• 1 other identifier: PF614-201
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the onset of analgesia following administration of a single oral dose of PF614 (50 mg or 100 mg) or placebo in healthy male subjects in an experimental pain model (cold pressor test \[CPT\]).

Conditions

Acute Pain

Keywords

Cold Pressor Test; CPT; Experimental Pain

Outcome Measures

Primary Outcomes (2)

• Change from Baseline (pre-dose) in Time to Pain Onset (defined as time to first pain)

  The time to first pain was recorded by trained site staff using a stop watch. Each subject was instructed to remove their hand at 3 minutes if they had not yet reached pain tolerance. Separate assessments were made at pre-dose (within 60 minutes prior to dosing; at least duplicate measurements, 30 minutes apart) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hours post-dose.

  6 hours

• Change from Baseline in Pain Tolerance (defined as latency time required for removal of hand from water bath)

  The latency time to hand removal from the water bath was recorded by trained site staff using a separate stopwatch. Separate assessments were made at pre-dose (within 60 minutes prior to dosing; at least duplicate measurements, 30 minutes apart) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hours post-dose.

  6 hours

Secondary Outcomes (1)

• Change from Baseline in Maximum Pain Intensity (pain NRS)

  6 hours

Other Outcomes (9)

• Change from Baseline in Dorsal Skin Temperature of the hand used in the CPT

  6 hours

• Safety Endpoints

  3 days

• Safety Endpoints

  3 days

Study Arms (3)

PF614 50 mg

EXPERIMENTAL

Oral 50 mg

Drug: PF614

PF614 100 mg

EXPERIMENTAL

Oral 100 mg

Drug: PF614

Placebo

PLACEBO COMPARATOR

Inactive medication

Drug: Placebo

Interventions

PF614 DRUG

Experimental oxycodone prodrug

Also known as: Oxycodone prodrug

PF614 100 mg; PF614 50 mg

Placebo DRUG

Inactive medication

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking males, ages 18-55 years, inclusive, in good general health.
• Body mass index (BMI) within the range of 18.0 to 34.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
• Subjects must have completed at least 2 CPTs at Screening (minimum 30 minutes apart or when the dorsal surface hand skin temperature had returned to baseline temperature \[±2°C\]), with both tests resulting in latency time of greater than 20 seconds and less than 120 seconds.
• Subjects must have had prior therapeutic experience with use of opioids for analgesia without showing signs of opioid-induced vomiting, dysphoria, or clinically significant sedation.
• Subjects must have agreed to use a double-barrier contraceptive method (condom and spermicide, or condom along with female partner's contraceptive method \[oral, injectable, implanted, transdermal, or intrauterine device (IUD) with or without hormones\]), or at least one partner was confirmed to be surgically sterile, or subject must have agreed to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for 90 days following the last administration of study drug. Subjects must have agreed to not donate sperm during the study and for 90 days following the last administration of study drug.
• Subjects must have been able to speak, read, and understand English sufficiently to allow completion of all study assessments.
• Subjects must have been able to provide written informed consent.
• Subjects must have been willing and able to follow study instructions and been likely to complete all study requirements.

You may not qualify if:

• Lifetime history or presence of substance or alcohol use disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition, Text Revision (DSM-V-TR).
• History or presence of clinically significant abnormality, as assessed by physical examination, medical history, electrocardiograms (ECGs), vital signs, or laboratory values, which, in the opinion of an investigator, would have jeopardized the safety of the subject or the validity of the study results. Retesting may have been permitted at the discretion of an investigator.
• History or presence of acute respiratory depression, chronic pulmonary disease, cor pulmonale, delirium tremens, central nervous system (CNS) depression, or increased cerebrospinal or intracranial pressure.
• History or presence of peripheral neuropathy or significant trauma or injury to non-dominant hand.
• Documented history of, or currently active, seizure disorder (excluding febrile seizures in childhood), history of clinically significant head injury or syncope of unknown origin.
• History or presence of obstructive sleep apnea.
• History of gastrointestinal disturbance requiring frequent use of antacids.
• History of or presence of trypsin deficiency.
• History of allergy or hypersensitivity to oxycodone, any other opioid or naloxone.
• Positive urine drug screen (UDS) or alcohol screen at Screening and at check-in to each treatment period (Day -1).
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV).
• Positive result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at check-in to each treatment period (Day -1). If a subject presented with a positive result, the subject may have been rescheduled at the discretion of the investigator and in agreement with the sponsor.
• Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 × the upper limit of normal (ULN). Retesting may have been permitted at the discretion of an investigator at Screening and at admission to Treatment Period 1 (Day -1).
• Use of prescription drugs and natural health products (e.g., herbal remedies) within at least 14 days or at least 5 times the t½ of the drug (if known), prior to first study drug administration in the Treatment Phase, whichever was longer.
• Use of non-prescription (over-the-counter) drugs within at least 7 days or at least 5 times the t½ of the drug (if known), prior to first study drug administration in the Treatment Phase, whichever was longer. On a case-by-case basis, the medical monitor may have allowed some over-the-counter medications within the 7 day window if the t½ of the drug was short.

Sponsors & Collaborators

• Ensysce Biosciences: lead
• Dr. Vince Clinical Research: collaborator

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

Related Publications (2)

• Kirkpatrick DL, Schmidt WK, Morales R, Cremin J, Seroogy J, Husfeld C, Jenkins T. In vitro and in vivo assessment of the abuse potential of PF614, a novel BIO-MD prodrug of oxycodone. J Opioid Manag. 2017 Jan/Feb;13(1):39-49. doi: 10.5055/jom.2017.0366.

  PMID: 28345745 BACKGROUND

• Kirkpatrick DL, Evans C, Pestano LA, Millard J, Johnston M, Mick E, Schmidt WK. Clinical evaluation of PF614, a novel TAAP prodrug of oxycodone, versus OxyContin in a multi-ascending dose study with a bioequivalence arm in healthy volunteers. Clin Transl Sci. 2024 Mar;17(3):e13765. doi: 10.1111/cts.13765.

  PMID: 38511523 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William K Schmidt, PhD

  Ensysce Biosciences Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Methodology: This will be a randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the onset of analgesia following administration of single oral doses of PF614 or placebo. The study will consist of 2 phases: Screening and Treatment.

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: October 5, 2023
• Primary Completion: November 14, 2023
• Study Completion: November 15, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)