A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects
Overview
- Phase
- Phase 2
- Intervention
- PF614
- Conditions
- Acute Pain
- Sponsor
- Ensysce Biosciences
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Change from Baseline (pre-dose) in Time to Pain Onset (defined as time to first pain)
- Status
- Completed
- Last Updated
- last year
Overview
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]).
Detailed Description
Researchers will compare drug PF614 to a placebo (a look-alike substance that contains no drug) to see if drug PF614 works to prevent moderate-to-severe experimental pain. Study subjects will: * On the Screening Day: Immerse their non-dominant hand in an ice cold water bath to assess their baseline pain threshold. Subjects will report when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes). * On Treatment Day 1: Repeat the initial CPT test for pain, then take drug PF614 or a placebo capsule (the study will be blinded so they won't know which treatment they received). After taking a single dose of study medication, they will be tested again for when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes) at 10 time periods up to 6 hours after taking the study medications. * Report adverse events, if any. * On Treatment Day 2: After a minimum of 5 days after Treatment Day 1, subjects will repeat the procedures from Treatment Day 1. They will receive the opposite medication that they received on Treatment Day 1 (this is a cross-over design). They will be tested again for when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes) at 10 time periods up to 6 hours after taking the study medications. * Report adverse events, if any.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
PF614 50 mg
Oral 50 mg
Intervention: PF614
PF614 100 mg
Oral 100 mg
Intervention: PF614
Placebo
Inactive medication
Intervention: Placebo
Outcomes
Primary Outcomes
Change from Baseline (pre-dose) in Time to Pain Onset (defined as time to first pain)
Time Frame: 6 hours
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.
Change from Baseline in Pain Tolerance (defined as latency time required for removal of hand from water bath)
Time Frame: 6 hours
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.
Secondary Outcomes
- Change from Baseline in Maximum Pain Intensity (pain NRS)(6 hours)