Recreational Drug UsePhase 1NCT05571345
A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104)
A Phase 1 study testing PF614 and Oxycodone Hydrochloride 40 mg in people with Recreational Drug Use, run by Ensysce Biosciences at 1 site in United States.
Trial summary
This will be a randomized, double-blind, placebo- and active-controlled, 5-way crossover study to evaluate the abuse potential, safety and pharmacokinetics of orally administered PF614 relative to oxycodone IR (immediate-release) tablets and placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Recreational Drug Use
- What is being tested?
- PF614 and Oxycodone Hydrochloride 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 28 Dec 2022
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females, 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.
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the past year and have used opioids at least once in the 12 weeks before Screening.
- Must not be physically dependent on opioids, as demonstrated by successful completion of the Naloxone Challenge Test.
- Must meet Drug Discrimination Test (Qualification Phase) eligibility criteria.
- Female subjects must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at admission to Visit 2. Post-menopausal women (i.e., no menstrual period for at least one year) must have a follicle-stimulation hormone (FSH) level >40 milli-international unit (mIU)/mL at Screening.
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- Female subjects of child-bearing potential must use an acceptable method of contraception, including abstinence from heterosexual intercourse, hormonal contraceptives, intrauterine device (IUD) with or without hormones, or double-barrier method (e.g., condom and spermicide), for 30 days prior to Screening, during the study and for 30 days following the last administration of study drug.
- Female subjects of non-childbearing potential should be surgically sterile (i.e., have undergone complete hysterectomy, bilateral oophorectomy or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels of > 40 IU/L.
- Male subjects must agree to use a double-barrier method (condom and spermicide) or agree 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.
- Male subjects must agree not to donate sperm during the study and for 90 days following the last administration of study drug.
- Subjects must be able to speak, read, and understand English sufficiently to allow completion of all study assessments.
- Subjects must be able to provide written informed consent.
- Subjects must be willing and able to follow study instructions and be likely to complete all study requirements.
Who cannot join
- Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM-IV-TR) or a lifetime history of opioid dependence.
- Has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence. If participation in a rehabilitation program was court mandated as part of a plea agreement, entry may be permissible at an investigator's discretion.
- Positive urine drug screen (UDS) for substances of abuse at admission to the Qualification Phase, excluding for tetrahydrocannabinol (THC). If a subject presents with a positive UDS at any visit, the subject may be rescheduled or the UDS may be repeated at the discretion of an investigator. If tetrahydrocannabinol (THC) is positive, inclusion will be at the discretion of an investigator, as long as the investigator determines there is no acute intoxication upon presentation.
- 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 jeopardize the safety of the subject or the validity of the study results. Retesting may be 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.
- Documented history of, or currently active, seizure disorder (excluding febrile seizures in childhood), history of clinically significant head injury or syncope of unknown origin.
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- History of gastrointestinal disturbance requiring frequent use of antacids.
- History of or presence of trypsin deficiency.
- Subjects with any history of suicidal ideation within the past 6 months or a lifetime history of suicidal behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) (baseline version).
- Heavy smoker (>20 cigarettes per day) and/or is unable to abstain from smoking or use of prohibited nicotine-containing products for at least 1 hour before and 8 hours after study drug administration in the Qualification and Treatment Phases (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine topical patches, nicotine gum or nicotine lozenges).
- History of allergy or hypersensitivity to oxycodone, any other opioid or naloxone.
- Female subjects who are currently pregnant (have a positive pregnancy test) or lactating, or who are planning to become pregnant within 30 days of last study drug administration.
- 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 the Qualification Phase (Day -1).
- 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 be permitted at the discretion of an investigator.
- Donation or loss of more than 500 mL whole blood within 56 days preceding entry into the Treatment Phase or has donated plasma within 7 days prior to Screening.
- Difficulty with venous access or is unsuitable or unwilling to undergo catheter insertion.
- Use of a prohibited medication or investigational product.
- Is an employee of the sponsor, a research site staff member directly affiliated with this study, or is 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) puts the subject at increased risk, (ii) could confound the study results, (iii) may interfere significantly with the subject's participation in the study, or (iv) has 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- and Active-Controlled Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets and Placebo in Non-Dependent Recreational Opioid Users
This will be a randomized, double-blind, placebo- and active-controlled, 5-way crossover study to evaluate the abuse potential, safety and pharmacokinetics of orally administered PF614 relative to oxycodone IR (immediate-release) tablets and placebo.
Read the detailed description
The study will consist of 4 phases: Screening, Qualification, Treatment and Follow-up.
- Screening Visit (Visit 1) The Screening Phase will be completed as an outpatient visit within 28 days of the Qualification Phase and will consist of a standard medical screen.
- Qualification Phase (Visit 2) Within 28 days of a standard medical screening, eligible subjects will return to the clinical site as inpatients to complete the Qualification Phase (Visit 2). Upon admission to the clinical site, subjects will be interviewed and assessed for continued eligibility for the study. Subjects will check into the inpatient facility on Day -1. The Qualification Phase will include a Naloxone Challenge Test to confirm that subjects are not opioid dependent and a Drug Discrimination Test to ensure that subjects can distinguish between the active control (oxycodone hydrochloride (HCl) immediate-release tablets 40 mg) and placebo. Eligible subjects who meet Qualification Criteria will remain as inpatient until the Treatment Phase. Subjects who do not meet Qualification Criteria will be discharged after all post-dose assessments have been performed after the last study drug administration. The last study drug administration in the Qualification Phase and the first study drug administration of the Treatment Phase will be separated by a washout period of approximately 72 hours.
- Treatment Phase (Visit 2-Continued) The Treatment Phase will consist of 5 treatment periods. Subjects will receive each of the following 5 treatments (1 per treatment period) in a randomized, double-blind, crossover manner, following a fasting period of at least 8 hours:
- Treatment A: PF614 50 mg
- Treatment B: PF614 100 mg
- Treatment C: PF614 200 mg
- Treatment D: Oxycodone IR 40 mg
- Treatment E: Placebo Pharmacodynamic, pharmacokinetic and safety assessments will be conducted prior to dosing and for 24 hours after each study drug administration. Each study drug administration will be separated by a washout interval of approximately 120 hours. All subjects will remain in clinic for the duration of the Treatment Phase. Subjects will be discharged after all post-dose assessments are performed at End of Treatment (EOT), if considered medically suitable for discharge by the investigator.
- Follow-up Visit (Visit 3) A follow-up visit will be conducted at 8 days (±2 days) after last study drug administration in the Treatment Phase or after early termination (EOS/ET) from the study.
- Conditions
- Recreational Drug Use
- Being tested
- PF614, Oxycodone Hydrochloride 40 mg, Placebo
- Keywords
- Non-dependent
- Medical subject headings
- Recreational Drug Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF614Drug
Also called Oxycodone prodrug
PF614 capsules (50 mg or 100 mg)
Oxycodone Hydrochloride 40 mgDrug
Also called Oxycodone hydrochloride (HCl) immediate-release (IR) tablets, 40 mg, Roxicodone or generic equivalent, 40 mg
Oral 20 mg tablets (two each)
PlaceboDrug
Also called Placebo capsules
Placebo to match PF614 capsules will be provided by the sponsor.
| Study group | Role | What they receive |
|---|---|---|
| PF614 50 mg | Experimental | PF614 50 mg capsule (1 x 50 mg capsule over-encapsulated and 1 x placebo to match PF614 capsule) Receives: Drug: PF614 |
| PF614 100 mg | Experimental | PF614 100 mg capsule (1 x 100 mg capsule and 1 x placebo to match PF614 capsule) Receives: Drug: PF614 |
| PF614 200 mg | Experimental | PF614 200 mg capsule (2 x 100 mg capsules) Receives: Drug: PF614 |
| Oxycodone IR 40 mg | Active comparator | Oxycodone HCl 40 mg (2 x 20 mg capsules over-encapsulated to match PF614 capsules). Receives: Drug: Oxycodone Hydrochloride 40 mg |
| Placebo | Placebo comparator | Placebo capsules to match PF614 (2 x placebo capsules) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)
Relative abuse potential of PF614 compared to Oxycodone and Placebo (I). Emax for drug liking VAS will be reported. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
Measured: Up to 24 hour post-dose (up to Day 2)
Take Drug Again VAS (Emax)
Relative abuse potential of PF614 compared to Oxycodone and Placebo (II). Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).
Measured: 12 hours post-dose
Take Drug Again VAS (Emax)
Relative abuse potential of PF614 compared to Oxycodone and Placebo (II). Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).
Measured: 24 hours post-dose
Secondary outcomes (6)
Maximum Plasma Concentration (Cmax)
Compare the peak plasma concentration of oxycodone derived from PF614 and oxycodone derived from oxycodone IR tablets
Measured: Up to 24 hour post-dose (up to Day 2)
Time to Peak Plasma Concentration (Tmax)
Compare the time to peak plasma concentration of oxycodone derived from PF614 and oxycodone derived from oxycodone IR tablets
Measured: Up to 24 hour post-dose (up to Day 2)
Area Under the Curve Plasma Concentration (AUC 0-24)
Compare the 0-24 hr pharmacokinetic profile of oxycodone derived from PF614 and oxycodone derived from oxycodone IR tablets
Measured: Up to 24 hour post-dose (up to Day 2)
Adverse events (AEs)
Safety
Measured: Through study completion, an average of 2.5 months
Serious adverse events (SAEs)
Safety
Measured: Through study completion, an average of 2.5 months
AEs leading to discontinuation
Safety
Measured: Through study completion, an average of 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start5 Oct 2022
- Primary completion23 Dec 2022
- Study completion28 Dec 2022
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 Recreational Drug UseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The Treatment Phase will consist of 5 treatment periods. Subjects will receive each of the following 5 treatments (1 per treatment period) in a randomized, double-blind, crossover manner, following a fasting period of at least 8 hours. Pharmacodynamic, pharmacokinetic and safety assessments will be conducted prior to dosing and for 24 hours after each study drug administration. Each study drug administration will be separated by a washout interval of approximately 120 hours. All subjects will remain in clinic for the duration of the Treatment Phase.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ensysce Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Responsible party
- Sponsor
- Investigators
- Lynn Kirkpatrick, PhD, Study chair, Ensysce Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571345
- Sponsor's protocol ID
- PF614-104
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2022
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for sharing individual participant data.
Publications
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.
PubMed 38511523Kirkpatrick 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 28345745
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets and Placebo in Non-Dependent Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT05571345
- Acronym / sponsor ID
- PF614-104
- Conditions
- Recreational Drug Use
- Keywords
- Non-dependent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ensysce BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 7 Oct 2022 (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.
This will be a randomized, double-blind, placebo- and active-controlled, 5-way crossover study to evaluate the abuse potential, safety and pharmacokinetics of orally administered PF614 relative to oxycodone IR (immediate-release) tablets and placebo.
Detailed description
The study will consist of 4 phases: Screening, Qualification, Treatment and Follow-up.
- Screening Visit (Visit 1) The Screening Phase will be completed as an outpatient visit within 28 days of the Qualification Phase and will consist of a standard medical screen.
- Qualification Phase (Visit 2) Within 28 days of a standard medical screening, eligible subjects will return to the clinical site as inpatients to complete the Qualification Phase (Visit 2). Upon admission to the clinical site, subjects will be interviewed and assessed for continued eligibility for the study. Subjects will check into the inpatient facility on Day -1. The Qualification Phase will include a Naloxone Challenge Test to confirm that subjects are not opioid dependent and a Drug Discrimination Test to ensure that subjects can distinguish between the active control (oxycodone hydrochloride (HCl) immediate-release tablets 40 mg) and placebo. Eligible subjects who meet Qualification Criteria will remain as inpatient until the Treatment Phase. Subjects who do not meet Qualification Criteria will be discharged after all post-dose assessments have been performed after the last study drug administration. The last study drug administration in the Qualification Phase and the first study drug administration of the Treatment Phase will be separated by a washout period of approximately 72 hours.
- Treatment Phase (Visit 2-Continued) The Treatment Phase will consist of 5 treatment periods. Subjects will receive each of the following 5 treatments (1 per treatment period) in a randomized, double-blind, crossover manner, following a fasting period of at least 8 hours:
- Treatment A: PF614 50 mg
- Treatment B: PF614 100 mg
- Treatment C: PF614 200 mg
- Treatment D: Oxycodone IR 40 mg
- Treatment E: Placebo Pharmacodynamic, pharmacokinetic and safety assessments will be conducted prior to dosing and for 24 hours after each study drug administration. Each study drug administration will be separated by a washout interval of approximately 120 hours. All subjects will remain in clinic for the duration of the Treatment Phase. Subjects will be discharged after all post-dose assessments are performed at End of Treatment (EOT), if considered medically suitable for discharge by the investigator.
- Follow-up Visit (Visit 3) A follow-up visit will be conducted at 8 days (±2 days) after last study drug administration in the Treatment Phase or after early termination (EOS/ET) from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- The Treatment Phase will consist of 5 treatment periods. Subjects will receive each of the following 5 treatments (1 per treatment period) in a randomized, double-blind, crossover manner, following a fasting period of at least 8 hours. Pharmacodynamic, pharmacokinetic and safety assessments will be conducted prior to dosing and for 24 hours after each study drug administration. Each study drug administration will be separated by a washout interval of approximately 120 hours. All subjects will remain in clinic for the duration of the Treatment Phase.
| Arm | Type | Receives |
|---|---|---|
| PF614 50 mg | Experimental | Drug: PF614PF614 50 mg capsule (1 x 50 mg capsule over-encapsulated and 1 x placebo to match PF614 capsule) |
| PF614 100 mg | Experimental | Drug: PF614PF614 100 mg capsule (1 x 100 mg capsule and 1 x placebo to match PF614 capsule) |
| PF614 200 mg | Experimental | Drug: PF614PF614 200 mg capsule (2 x 100 mg capsules) |
| Oxycodone IR 40 mg | Active comparator | Drug: Oxycodone Hydrochloride 40 mgOxycodone HCl 40 mg (2 x 20 mg capsules over-encapsulated to match PF614 capsules). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules to match PF614 (2 x placebo capsules) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Males or females, 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.
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least 10 times in the past year and have used opioids at least once in the 12 weeks before Screening.
- Must not be physically dependent on opioids, as demonstrated by successful completion of the Naloxone Challenge Test.
- Must meet Drug Discrimination Test (Qualification Phase) eligibility criteria.
Key exclusion criteria (20 listed)
- Substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM-IV-TR) or a lifetime history of opioid dependence.
- Has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence. If participation in a rehabilitation program was court mandated as part of a plea agreement, entry may be permissible at an investigator's discretion.
- Positive urine drug screen (UDS) for substances of abuse at admission to the Qualification Phase, excluding for tetrahydrocannabinol (THC). If a subject presents with a positive UDS at any visit, the subject may be rescheduled or the UDS may be repeated at the discretion of an investigator. If tetrahydrocannabinol (THC) is positive, inclusion will be at the discretion of an investigator, as long as the investigator determines there is no acute intoxication upon presentation.
- 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 jeopardize the safety of the subject or the validity of the study results. Retesting may be 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.
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 prodrugPF614 capsules (50 mg or 100 mg) | Drug | PF614 100 mg, PF614 200 mg, PF614 50 mg |
| Oxycodone Hydrochloride 40 mgAlso: Oxycodone hydrochloride (HCl) immediate-release (IR) tablets, 40 mg, Roxicodone or generic equivalent, 40 mgOral 20 mg tablets (two each) | Drug | Oxycodone IR 40 mg |
| PlaceboAlso: Placebo capsulesPlacebo to match PF614 capsules will be provided by the sponsor. | Drug | Placebo |
Primary outcome
Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS)
Time frame: Up to 24 hour post-dose (up to Day 2)
Relative abuse potential of PF614 compared to Oxycodone and Placebo (I). Emax for drug liking VAS will be reported. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
Take Drug Again VAS (Emax)
Time frame: 12 hours post-dose
Relative abuse potential of PF614 compared to Oxycodone and Placebo (II). Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).
Take Drug Again VAS (Emax)
Time frame: 24 hours post-dose
Relative abuse potential of PF614 compared to Oxycodone and Placebo (II). Emax for take drug again VAS will be reported. Peak effect for take drug again based on bipolar VAS from 0 (definitely no) to 100 (definitely so).
6 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: Up to 24 hour post-dose (up to Day 2)
Time to Peak Plasma Concentration (Tmax)
Time frame: Up to 24 hour post-dose (up to Day 2)
Area Under the Curve Plasma Concentration (AUC 0-24)
Time frame: Up to 24 hour post-dose (up to Day 2)
Adverse events (AEs)
Time frame: Through study completion, an average of 2.5 months
Serious adverse events (SAEs)
Time frame: Through study completion, an average of 2.5 months
AEs leading to discontinuation
Time frame: Through study completion, an average of 2.5 months
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 24 Sep 2024.
- 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.
- 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.
- Individual participant dataSharing planned: No. There is no plan for sharing individual participant data.
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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.
Lynn Kirkpatrick, PhD study chair
Ensysce Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF614 and Oxycodone Hydrochloride 40 mg in people with Recreational Drug Use, 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 13 inclusion and 20 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 24 Sep 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Peak Maximum Effect (Emax) for Drug Liking (At this Moment) Visual Analog Scale (VAS) (time frame: Up to 24 hour post-dose (up to Day 2)). The study lists 3 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 NCT05571345, 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 24 Sep 2024.