Acute PainPhase 2CPTNCT06629402
Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)
A Phase 2 study testing PF614 in people with Acute Pain, run by Ensysce Biosciences at 1 site in United States.
Trial 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]). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- PF614
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 15 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- Use of any enzyme-modifying drugs or products, including strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., clarithromycin, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, voriconazole, cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort) within 30 days of first study drug administration in the Treatment Phase.
- Use of investigational drugs within at least 30 days or 5 times the t½ of the drug (if known), whichever was longer, prior to first study drug administration in the Treatment Phase.
- Use of tobacco- or nicotine-containing products in the 3 months prior to Screening.
- Donation or loss of blood in excess of 500 mL within 56 days prior to Screening, or plasma within 7 days prior to Screening.
- Subject was an employee of the sponsor, a research site staff member directly affiliated with this study, or was an immediate family member, defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Any other condition that, in an investigator's opinion, (i) put the subject at increased risk, (ii) could have confounded the study results, (iii) may have interfered significantly with the subject's participation in the study, or (iv) had the potential to limit the subject's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects
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]).
Read the 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.
- Conditions
- Acute Pain
- Being tested
- PF614, Placebo
- Keywords
- Cold Pressor Test, CPT, Experimental Pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF614Drug
Also called Oxycodone prodrug
Experimental oxycodone prodrug
PlaceboDrug
Also called Control
Inactive medication
| Study group | Role | What they receive |
|---|---|---|
| PF614 50 mg | Experimental | Oral 50 mg Receives: Drug: PF614 |
| PF614 100 mg | Experimental | Oral 100 mg Receives: Drug: PF614 |
| Placebo | Placebo comparator | Inactive medication Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 hours
Secondary outcomes (1)
Change from Baseline in Maximum Pain Intensity (pain NRS)
A pain intensity score (maximum pain intensity = most intense pain felt during the immersion period) was rated on an 11-point numerical rating scale (NRS) after the subject removed their hand. 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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start5 Oct 2023
- Primary completion14 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ensysce Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Responsible party
- Sponsor
- Investigators
- William K Schmidt, PhD, Study director, Ensysce Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629402
- Sponsor's protocol ID
- PF614-201
- Acronym
- CPT
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28345745Kirkpatrick 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.
PubMed 38511523
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06629402
- Acronym / sponsor ID
- CPT / PF614-201
- Conditions
- Acute Pain
- Keywords
- Cold Pressor Test, CPT, Experimental Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ensysce BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PF614 50 mg | Experimental | Drug: PF614Oral 50 mg |
| PF614 100 mg | Experimental | Drug: PF614Oral 100 mg |
| Placebo | Placebo comparator | Drug: PlaceboInactive medication |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF614Also: Oxycodone prodrugExperimental oxycodone prodrug | Drug | PF614 100 mg, PF614 50 mg |
| PlaceboAlso: ControlInactive medication | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Change from Baseline in Maximum Pain Intensity (pain NRS)
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 28345745Kirkpatrick 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.
- Background: PubMed 38511523Kirkpatrick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William K Schmidt, PhD study director
Ensysce Biosciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF614 in people with Acute Pain, run by Ensysce Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline (pre-dose) in Time to Pain Onset (defined as time to first pain) (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06629402, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.