Healthy VolunteersPhase 1NCT05043766
Evaluation of Oral PF614 Relative to OxyContin (PF614-102)
A Phase 1 study testing PF614, Naltrexone Hydrochloride and OxyContin in people with Healthy Volunteers, run by Ensysce Biosciences at 1 site in United States.
Trial summary
This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF614, Naltrexone Hydrochloride and OxyContin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2021to 21 Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, ages 18-50 years in good general health,
- BMI between 18 and 32 kg/m (inclusive)
- Subjects must have a negative screen for drugs of abuse, nicotine, alcohol, Hepatitis B, Hepatitis C, and HIV.
- Female subjects of child bearing potential must have a negative serum pregnancy test at randomization
- Females must be of non-child bearing potential (e.g. postmenopausal) or of childbearing potential and agree to use a highly effective form of contraception from the time of screening to two weeks after last dose of study medication.
- Subjects must have normal findings in a physical examination and 12 lead ECG and normal Vital Signs
Show all 9Show fewer
- Clinical laboratory values must be Within Normal limits as defined by the clinical laboratory
- Subjects must be able to provide coherent written informed consent
- Subjects must be willing and able to follow study instructions and be likely to complete all study requirements.
Who cannot join
- History of allergy or sensitivity to oxycodone
- History of loud snoring or sleep apnea
- History of medical problems encountered with opioid therapy
- Urinary cotinine levels indicative of smoking or history of smoking or regular tobacco use with 2 months prior to screening
- History of alcoholism or drug abuse
- Use of prescription medications within 14 days of study drug administration with exception of contraceptives used by female subjects
Show all 17Show fewer
- Use of any opioid within 30 days prior to screening
- History of allergy or sensitivity to naltrexone
- History of allergy or sensitivity to naloxone
- Donation of blood within 30 days prior to screening
- Donation of plasma within 30 days prior to screening
- Acute illness at admission of clinical study unit
- History of GI disturbance requiring use of antacid twice weekly or more
- Females who are breastfeeding
- Anticipated need for surgery or hospitalization during the study
- Enrollment in an investigational drug study within 30 days prior to screening
- Any condition that in the Investigator's opinion puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA Health Sciences-Early Development Services
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 1b, Randomized 2-Part Single-Center Study to Evaluate the PK and Safety of Multiple Ascending Oral Doses of PF614 and the Food Effect and BA/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects
This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects.
Read the detailed description
This study is intended to evaluate the pharmacokinetics of OxyContin (oxycodone ER) and PF614, as well as PF614 fragments, following administration of multiple ascending doses of PF614, and to compare to steady-state pharmacokinetics to those of OxyContin. (Part A)
In addition, oral bioavailability of oxycodone derived from single doses of PF614 of the to-be-marketed capsule formulation will be compared to that of the reference drug, OxyContin, in the fasted and fed condition. A pivotal food effect assessment will be incorporated into the study to determine the impact of a high fat meal on the bioavailability of oxycodone, following oral single-dose administration of PF614 (Part B).
- Conditions
- Healthy Volunteers
- Being tested
- PF614, Naltrexone Hydrochloride, OxyContin
- Keywords
- Prodrug, PF614, OxyContin, oral
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 is an oxycodone prodrug
Naltrexone HydrochlorideDrug
Also called ReVia
Naltrexone HCl tablets, 50 mg, will be used to block the opioid effects in healthy volunteers
OxyContinDrug
Also called OxyContin 40 mg Extended-Release Tablet
Bioequivalence single-dose comparison to OxyContin
| Study group | Role | What they receive |
|---|---|---|
| PF614 | Experimental | Part A will utilize a randomized, open-label, multiple-ascending dose design with up to 3 separate dose groups of 8 subjects. Within each dose group, subjects will be randomized to receive repeated BID doses, planned to be 12 hours apart over a 5 day period, for a total of 9 doses. Dose escalation to Dose Groups 2 and 3 will follow a review of pharmacokinetic, safety and tolerability data up to Day 10 of the preceding group. The doses or dosing regimen for Dose groups 2 and 3 may be modified based on a review of the data. Receives: Drug: PF614; Drug: Naltrexone Hydrochloride |
| Part B Compare Bioavailability and Bioequivalence | Active comparator | Part B will utilize an open-label, single-dose, randomized, 4-way crossover design. Following confirmation of eligibility, subjects will be randomized to receive each of the single oral doses of study drugs (one at each treatment period).
PF614 100 mg administered under fasted conditions; PF614 100 mg administered under fed conditions; OxyContin 40 mg administered under fasted conditions; OxyContin 40 mg administered under fed conditions Receives: Drug: PF614; Drug: Naltrexone Hydrochloride; Drug: OxyContin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events, Significant Adverse Events, Adverse Events leading to discontinuation
Measured: 30 days
Pharmacokinetics AUC [Area Under the Curve]
Area under the concentration-time curve from the time of dosing to the start of the next dosing interval using PF614 concentrations and oxycodone concentrations in plasma.
Measured: Full PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Cmax [Maximum Plasma Concentration]
Maximum (peak) plasma concentration first dose
Measured: PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Tlag [Time to first measurable plasma concentration]
Time prior to the time corresponding to the first measurable (non-zero) concentration
Measured: PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Tmax [Time to maximum plasma concentration]
Time to maximum plasma concentration on Day 1 (first dose)
Measured: PK sampling time points 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics AUC, Steady State
Steady-state (Day 5) area under the concentration-time curve from the time of dosing extrapolated to time infinity
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics CL/F [Clearance]
Apparent total systemic clearance
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Cmax, Steady State
Maximum (peak) plasma concentration at steady-state on Day 5
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Tmax, Steady State
Time to maximum plasma concentration on Day 5
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics t1/2 [Half-life]
Terminal elimination half-life
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Vz/F [Volume of Distribution]
Apparent volume of distribution during the terminal-elimination phase
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics elimination rate
Terminal elimination rate/constant
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Ctrough [Minimum Plasma Concentration before next dose]
Concentrations prior to dosing
Measured: Prior to dosing on Days 2, 3, and 4
Pharmacokinetics Part B AUC
Area under the concentration-time curve from the time of dosing extrapolated to time infinity in fed vs fasted state
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B AUC 0-t
Area under the concentration-time curve from the time of dosing to the last measurable concentration in fed vs fasted state
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Cmax
Maximum (peak) plasma concentration in fed vs fasted state
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Bioavailability and Bioequivalence
Bioavailability and Bioequivalence of single oral doses of PF614 prodrug and oxycodone derived from from PF614 vs. oxycodone derived from OxyContin in healthy adult subjects (Part B)
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Secondary outcomes (9)
Pharmacokinetics Part B CL/F
Apparent total systemic clearance
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B pAUC
Partial area under the concentration-time curve from the time of dosing to 12 hours post dose
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Tlag
Time prior to the time corresponding to the first measurable dose (non-zero) concentration
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Tmax
Time to maximum plasma concentration on Day 1 (first dose)
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B t1/2
Terminal elimination half life
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Vz/F
Apparent volume of distribution during the terminal elimination phase
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Terminal elimination rate
Terminal elimination rate constant
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Plasma Concentration of inactive metabolic fragment #1
Evaluate plasma concentrations of PFR06082 (Part A only)
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Plasma Concentration of inactive metabolic fragment #2
Evaluate plasma concentrations of PFR06110 (Part A only)
Measured: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start8 Sep 2021
- Primary completion21 Mar 2022
- Study completion21 Mar 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 Healthy VolunteersStudies 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
- Part A will utilize a randomized, open label, multiple-ascending dose design with up to 3 separate dose groups of 8 subjects per group. Part B will utilize an open-label, single-dose, randomized, 4-way crossover design with 13 subjects in each treatment sequence.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ensysce Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
- Investigators
- William K Schmidt, PhD, Study director, Chief Medical Officer, Ensysce Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043766
- Sponsor's protocol ID
- PF614-102
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2021
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized 2-Part Single-Center Study to Evaluate the PK and Safety of Multiple Ascending Oral Doses of PF614 and the Food Effect and BA/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05043766
- Acronym / sponsor ID
- PF614-102
- Conditions
- Healthy Volunteers
- Keywords
- Prodrug, PF614, OxyContin, oral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ensysce BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 14 Sep 2021 (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 is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects.
Detailed description
This study is intended to evaluate the pharmacokinetics of OxyContin (oxycodone ER) and PF614, as well as PF614 fragments, following administration of multiple ascending doses of PF614, and to compare to steady-state pharmacokinetics to those of OxyContin. (Part A)
In addition, oral bioavailability of oxycodone derived from single doses of PF614 of the to-be-marketed capsule formulation will be compared to that of the reference drug, OxyContin, in the fasted and fed condition. A pivotal food effect assessment will be incorporated into the study to determine the impact of a high fat meal on the bioavailability of oxycodone, following oral single-dose administration of PF614 (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part A will utilize a randomized, open label, multiple-ascending dose design with up to 3 separate dose groups of 8 subjects per group. Part B will utilize an open-label, single-dose, randomized, 4-way crossover design with 13 subjects in each treatment sequence.
| Arm | Type | Receives |
|---|---|---|
| PF614 | Experimental | Drug: PF614, Drug: Naltrexone HydrochloridePart A will utilize a randomized, open-label, multiple-ascending dose design with up to 3 separate dose groups of 8 subjects. Within each dose group, subjects will be randomized to receive repeated BID doses, planned to be 12 hours apart over a 5 day period, for a total of 9 doses. Dose escalation to Dose Groups 2 and 3 will follow a review of pharmacokinetic, safety and tolerability data up to Day 10 of the preceding group. The doses or dosing regimen for Dose groups 2 and 3 may be modified based on a review of the data. |
| Part B Compare Bioavailability and Bioequivalence | Active comparator | Drug: PF614, Drug: Naltrexone Hydrochloride, Drug: OxyContinPart B will utilize an open-label, single-dose, randomized, 4-way crossover design. Following confirmation of eligibility, subjects will be randomized to receive each of the single oral doses of study drugs (one at each treatment period). PF614 100 mg administered under fasted conditions; PF614 100 mg administered under fed conditions; OxyContin 40 mg administered under fasted conditions; OxyContin 40 mg administered under fed conditions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males or females, ages 18-50 years in good general health,
- BMI between 18 and 32 kg/m (inclusive)
- Subjects must have a negative screen for drugs of abuse, nicotine, alcohol, Hepatitis B, Hepatitis C, and HIV.
- Female subjects of child bearing potential must have a negative serum pregnancy test at randomization
- Females must be of non-child bearing potential (e.g. postmenopausal) or of childbearing potential and agree to use a highly effective form of contraception from the time of screening to two weeks after last dose of study medication.
Key exclusion criteria (17 listed)
- History of allergy or sensitivity to oxycodone
- History of loud snoring or sleep apnea
- History of medical problems encountered with opioid therapy
- Urinary cotinine levels indicative of smoking or history of smoking or regular tobacco use with 2 months prior to screening
- History of alcoholism or drug abuse
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 is an oxycodone prodrug | Drug | PF614, Part B Compare Bioavailability and Bioequivalence |
| Naltrexone HydrochlorideAlso: ReViaNaltrexone HCl tablets, 50 mg, will be used to block the opioid effects in healthy volunteers | Drug | PF614, Part B Compare Bioavailability and Bioequivalence |
| OxyContinAlso: OxyContin 40 mg Extended-Release TabletBioequivalence single-dose comparison to OxyContin | Drug | Part B Compare Bioavailability and Bioequivalence |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 30 days
Adverse Events, Significant Adverse Events, Adverse Events leading to discontinuation
Pharmacokinetics AUC [Area Under the Curve]
Time frame: Full PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Area under the concentration-time curve from the time of dosing to the start of the next dosing interval using PF614 concentrations and oxycodone concentrations in plasma.
Pharmacokinetics Cmax [Maximum Plasma Concentration]
Time frame: PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Maximum (peak) plasma concentration first dose
Pharmacokinetics Tlag [Time to first measurable plasma concentration]
Time frame: PK sampling time points will be 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Time prior to the time corresponding to the first measurable (non-zero) concentration
Pharmacokinetics Tmax [Time to maximum plasma concentration]
Time frame: PK sampling time points 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Time to maximum plasma concentration on Day 1 (first dose)
Pharmacokinetics AUC, Steady State
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Steady-state (Day 5) area under the concentration-time curve from the time of dosing extrapolated to time infinity
Pharmacokinetics CL/F [Clearance]
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Apparent total systemic clearance
Pharmacokinetics Cmax, Steady State
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Maximum (peak) plasma concentration at steady-state on Day 5
Pharmacokinetics Tmax, Steady State
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Time to maximum plasma concentration on Day 5
Pharmacokinetics t1/2 [Half-life]
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Terminal elimination half-life
Pharmacokinetics Vz/F [Volume of Distribution]
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Apparent volume of distribution during the terminal-elimination phase
Pharmacokinetics elimination rate
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Terminal elimination rate/constant
Pharmacokinetics Ctrough [Minimum Plasma Concentration before next dose]
Time frame: Prior to dosing on Days 2, 3, and 4
Concentrations prior to dosing
Pharmacokinetics Part B AUC
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Area under the concentration-time curve from the time of dosing extrapolated to time infinity in fed vs fasted state
Pharmacokinetics Part B AUC 0-t
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Area under the concentration-time curve from the time of dosing to the last measurable concentration in fed vs fasted state
Pharmacokinetics Part B Cmax
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Maximum (peak) plasma concentration in fed vs fasted state
Bioavailability and Bioequivalence
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Bioavailability and Bioequivalence of single oral doses of PF614 prodrug and oxycodone derived from from PF614 vs. oxycodone derived from OxyContin in healthy adult subjects (Part B)
9 secondary outcomes
Pharmacokinetics Part B CL/F
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B pAUC
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Tlag
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Tmax
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B t1/2
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Vz/F
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Pharmacokinetics Part B Terminal elimination rate
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Plasma Concentration of inactive metabolic fragment #1
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 hours
Plasma Concentration of inactive metabolic fragment #2
Time frame: PK sampling time points 0, 30 minutes; 1, 2, 3, 4, 6, 8, and 12 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 24 Sep 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.
- Results publication: 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
Chief Medical Officer, 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, Naltrexone Hydrochloride and OxyContin in people with Healthy Volunteers, 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 9 inclusion and 17 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. 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 30 days). The study lists 17 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 NCT05043766, 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.