PharmacokineticsPhase 1NCT06500793
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
A Phase 1 study testing PF614 capsule and Nafamostat Mesylate in people with Pharmacokinetics and Healthy Volunteer, run by Ensysce Biosciences at 1 site in United States.
Trial summary
A single dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Healthy Volunteer
- What is being tested?
- PF614 capsule and Nafamostat Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2024to 28 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
- Must be willing and able to comply with all study requirements.
- Aged 18 to 55 years, inclusive, at time of signing informed consent.
- Must agree to use an adequate method of contraception (as defined in Section 9.4).
- Healthy males or non pregnant, non lactating healthy females.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
- Minimum weight of 50 kg at screening.
Who cannot join
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
- Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease (Part 1 only: except cholecystectomy), gastrointestinal surgery (e.g. gastric bypass, gastric banding, colectomy), or neurological or psychiatric disorder, as judged by the investigator.
- Subjects with a history of seizures.
- Subjects with history of GI bleeding (excluding hemorrhoids) or history of peptic or duodenal ulcer disease.
Show all 32Show fewer
- Subjects with a history of bleeding disorders or coagulopathy.
- Subjects with any personal history of arrhythmias or family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction prior to 50 years old).
- Parts 2 and 3 only: Subjects with a history of cholecystectomy or gall stones.
- Parts 2 and 3 only: Subjects with a history of opioid intolerance or hypersensitivity based on previous experience receiving any opioid analgesic
- Have poor venous access that limits phlebotomy.
- Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). Subjects with Gilbert's Syndrome are allowed.
- Subjects with a platelet count <150,000/µL or international normalized ratio >1.1 at screening.
- Subjects with hemoglobin <LLN at screening and/or first admission.
- Subjects with a QT interval corrected using Fridericia's formula (QTcF) above 450 msec at screening and/or first admission.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- Positive serum pregnancy test at screening or first admission. Those who are pregnant or lactating will be excluded.
- Subjects who have received any IMP in a clinical research study within 5 half lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IMP and first dose be less than 30 days.
- Subjects who have previously been administered IMP in this study.
- Subjects who are taking, or have taken, any prescribed or over the counter drug or herbal remedies (other than up to 4 g per day acetaminophen, HRT or hormonal contraception) in the 14 days before study treatment administration (see Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
- Subjects with an anticipated need for requiring aspirin, non-steroidal anti-inflammatory drugs, or anticoagulants in the 14 days after administration of the IMP.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine).
- A confirmed positive alcohol urine test at screening or first admission.
- Current smokers and those who have smoked within the last 12 months.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
- A confirmed positive urine cotinine test at screening or first admission.
- Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1).
- Male subjects with pregnant or lactating partners.
- Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study treatment.
- Subjects who are, or are immediate family members of, a study site or sponsor employee.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Quotient Sciences
Miami, Florida, 33126
Claire Swann, Claire.Swann@quotientsciences.com
Jeffrey Levy, MD, PhD
About this study
Official title: A Single Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered With Nafamostat as a Combination IR Solution and ER Capsule Formulation in Healthy Subjects
A single dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.
Read the detailed description
PF614-MPAR is a combination of an oxycodone prodrug (PF614) and a protease inhibitor (nafamostat) that is intended to provide overdose protection when more than a prescribed dose may be taken simultaneously. A previous study (QSC203698) has explored various nafamostat formulations and identified an optimal combination of immediate release (IR) nafamostat and an extended release (ER) bead that when co-administered with 25 mg PF614 does not impact oxycodone exposure. However, when administered in an overdose situation (8 x unit dose level, 200 mg PF614 and 8 mg nafamostat), the nafamostat was able to inhibit trypsin which prevented the conversion of PF614 to oxycodone and hence prevented increased exposure of oxycodone when compared to 200 mg PF614 in the absence of nafamostat. The nafamostat formulation for the PF614 25 mg dose unit was identified 1 mg total nafamostat comprised of 0.75 mg IR and 0.25 mg ER beads (80:20 coating ratio). Ultimately the study defined the PF614-MPAR 25 mg dose unit.
Part 1 of the current study aims to define the PF614-MPAR 100 mg dose unit that is intended for commercialization, by exploring the impact of nafamostat on release of oxycodone from PF614 in naltrexone blocked healthy volunteers. Exposure of both oxycodone and PF614 will be evaluated following administration of 100 mg PF614-MPAR (PF614 and nafamostat (1 mg) as single dose unit or when administered up to 5 dose units simultaneously). If the nafamostat dose needs adjusting with 100 mg PF614, then this will also be assessed with the 50 mg PF614 dose unit in optional Part 1b. Part 1 will also assess exposure of a new 100 mg PF614 capsule formulation. In Part 2, the food effect will be assessed at the highest PF614 and nafamostat dose. If Part 1 is able to identify an appropriate PF614-nafamostat ratio then optional Part 3 will investigate PF614 and oxycodone exposure when 25 mg PF614 is co-administered with varying concentrations of nafamostat (IR and ER beads) in both the fed and fasted states. Part 3 of the study will also assess the impact of dosing PF614 and nafamostat in standard (uncoated) or enteric-coated (EC) capsules on the exposure of oxycodone in both the fed and fasted state. An Optional Period may investigate PF614 administered alone in the fed and fasted state.
The current study proposes to dose up to 500 mg PF614 (equivalent to 200 mg oxycodone); the 50 mg daily doses of naltrexone are anticipated to be more than sufficient to block 200 mg of an oxycodone-equivalent exposure.
- Conditions
- Pharmacokinetics, Healthy Volunteer
- Being tested
- PF614 capsule, Nafamostat Mesylate
- Keywords
- PF614, oxycodone, nafamostat, MPAR, overdose protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF614 capsuleDrug
Also called PRF06104, Oxycodone prodrug
PF614 capsules (25-100 mg)
Nafamostat MesylateDrug
Also called Futhan
Nafamostat IR/ER solution/beads/powder (total 1-25 mg)
| Study group | Role | What they receive |
|---|---|---|
| PF614 capsule with naltrexone HCl | Experimental | PF614 is an oxycodone prodrug. Part 1 doses = 100, 300 and up to 500 mg. Subjects will receive single daily doses at 5-14 days apart.
Naltrexone, 50 mg Oral (Day -1, Day 1 and Day 2). All subjects will receive naltrexone block Receives: Drug: PF614 capsule |
| PF614 capsule concomitantly with nafamostat and naltrexone HCl | Experimental | PF614 is an oxycodone prodrug. Part 1 doses = 100, 300 and up to 500 mg. Nafamostat Mesylate is a trypsin inhibitor that blocks PF614 activation. Nafamostat IR solution (0.75 - XX mg); Nafamostat ER beads in capsule formulation (0.25 - YY mg) Naltrexone, 50 mg Oral (Day -1, Day 1 and Day 2). All subjects will receive naltrexone block Receives: Drug: PF614 capsule; Drug: Nafamostat Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Tmax [Time to Maximum Plasma Concentration]
Time to maximum observed concentrations of oxycodone following administration of PF614 alone and with nafamostat
Measured: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic Cmax [Maximum Plasma Concentration]
Maximum (peak) observed concentration of oxycodone following administration of PF614 alone and with nafamostat
Measured: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic C24 [Plasma concentration at 24 hours]
Concentration of oxycodone at 24 hours post-dose following administration of PF614 alone and with nafamostat
Measured: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic AUC(0-last) [Area Under the Curve]
Area under the concentration-time curve from time 0 to the time of last measurable concentrations of oxycodone following administration of PF614 alone and with nafamostat
Measured: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic AUC(0-inf) [Area Under the Curve]
Area under the concentration-time curve from time 0 extrapolated to time-infinity of oxycodone following administration of PF614 alone and with nafamostat
Measured: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Pharmacokinetic T1/2 [Half-life]
Terminal elimination half-life concentrations of oxycodone following administration of PF614 alone and with nafamostat
Measured: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Effects [Safety and Tolerability]
Adverse events (AEs) including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs), safety laboratory evaluations (hematology, coagulation, clinical chemistry, urinalysis), 12-lead electrocardiograms (ECGs), vital sign measurements, pulse oximetry and physical examinations.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start24 Nov 2024
- Primary completion22 Dec 2026 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Single center, open-label study. Part 1 will assess impact of nafamostat (IR solution / ER beads) on oxycodone plasma levels when administered with 100 mg PF-614. Nafamostat will be increased from 1-10 mg if required to inhibit conversion of PF614 to oxycodone in an overdose situation (greater than 3 dose units taken simultaneously). Part 1 is intended to identify a nafamostat IR/ER combination that does not impact oxycodone release if 2 PF614 dose units are taken simultaneously yet show that nafamostat with 3 to 5 dose units inhibits conversion of PF614 to oxycodone in an OD situation (5 x 100 mg PF614 dose level). Results from Part 1 will define the dose units for Part 2 and 3. Part 2 will assess the impact of food on the exposure of PF-614 and nafamostat coadministered and PF-614 and nafamostat administered alone. Part 3 will assess varying concentrations of nafamostat (IR and ER beads) in both fed and fasted states.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ensysce Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Levy, MD, PhD, Principal investigator, Medical Director, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500793
- Sponsor's protocol ID
- QSC301193
- Status last verified
- May 2026
- First submitted
- 8 Jul 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirkpatrick DL, Pestano LA, Evans C, Millard J, Levy J, Zann V, Pepper K, Schmidt WK. Formulation development and a Phase 1 clinical study of PF614-MPAR, an oxycodone prodrug with oral opioid overdose protection. J Opioid Manag. 2026 Jan-Feb;22(1):37-A26. doi: 10.5055/jom.0991.
PubMed 41774070Kirkpatrick 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered With Nafamostat as a Combination IR Solution and ER Capsule Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06500793
- Acronym / sponsor ID
- QSC301193
- Conditions
- Pharmacokinetics, Healthy Volunteer
- Keywords
- PF614, oxycodone, nafamostat, MPAR, overdose protection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ensysce BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences, National Institute on Drug Abuse (NIDA)
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 28 Apr 2027 (estimated)
- First posted
- 15 Jul 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.
A single dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.
Detailed description
PF614-MPAR is a combination of an oxycodone prodrug (PF614) and a protease inhibitor (nafamostat) that is intended to provide overdose protection when more than a prescribed dose may be taken simultaneously. A previous study (QSC203698) has explored various nafamostat formulations and identified an optimal combination of immediate release (IR) nafamostat and an extended release (ER) bead that when co-administered with 25 mg PF614 does not impact oxycodone exposure. However, when administered in an overdose situation (8 x unit dose level, 200 mg PF614 and 8 mg nafamostat), the nafamostat was able to inhibit trypsin which prevented the conversion of PF614 to oxycodone and hence prevented increased exposure of oxycodone when compared to 200 mg PF614 in the absence of nafamostat. The nafamostat formulation for the PF614 25 mg dose unit was identified 1 mg total nafamostat comprised of 0.75 mg IR and 0.25 mg ER beads (80:20 coating ratio). Ultimately the study defined the PF614-MPAR 25 mg dose unit.
Part 1 of the current study aims to define the PF614-MPAR 100 mg dose unit that is intended for commercialization, by exploring the impact of nafamostat on release of oxycodone from PF614 in naltrexone blocked healthy volunteers. Exposure of both oxycodone and PF614 will be evaluated following administration of 100 mg PF614-MPAR (PF614 and nafamostat (1 mg) as single dose unit or when administered up to 5 dose units simultaneously). If the nafamostat dose needs adjusting with 100 mg PF614, then this will also be assessed with the 50 mg PF614 dose unit in optional Part 1b. Part 1 will also assess exposure of a new 100 mg PF614 capsule formulation. In Part 2, the food effect will be assessed at the highest PF614 and nafamostat dose. If Part 1 is able to identify an appropriate PF614-nafamostat ratio then optional Part 3 will investigate PF614 and oxycodone exposure when 25 mg PF614 is co-administered with varying concentrations of nafamostat (IR and ER beads) in both the fed and fasted states. Part 3 of the study will also assess the impact of dosing PF614 and nafamostat in standard (uncoated) or enteric-coated (EC) capsules on the exposure of oxycodone in both the fed and fasted state. An Optional Period may investigate PF614 administered alone in the fed and fasted state.
The current study proposes to dose up to 500 mg PF614 (equivalent to 200 mg oxycodone); the 50 mg daily doses of naltrexone are anticipated to be more than sufficient to block 200 mg of an oxycodone-equivalent exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, open-label study. Part 1 will assess impact of nafamostat (IR solution / ER beads) on oxycodone plasma levels when administered with 100 mg PF-614. Nafamostat will be increased from 1-10 mg if required to inhibit conversion of PF614 to oxycodone in an overdose situation (greater than 3 dose units taken simultaneously). Part 1 is intended to identify a nafamostat IR/ER combination that does not impact oxycodone release if 2 PF614 dose units are taken simultaneously yet show that nafamostat with 3 to 5 dose units inhibits conversion of PF614 to oxycodone in an OD situation (5 x 100 mg PF614 dose level). Results from Part 1 will define the dose units for Part 2 and 3. Part 2 will assess the impact of food on the exposure of PF-614 and nafamostat coadministered and PF-614 and nafamostat administered alone. Part 3 will assess varying concentrations of nafamostat (IR and ER beads) in both fed and fasted states.
| Arm | Type | Receives |
|---|---|---|
| PF614 capsule with naltrexone HCl | Experimental | Drug: PF614 capsulePF614 is an oxycodone prodrug. Part 1 doses = 100, 300 and up to 500 mg. Subjects will receive single daily doses at 5-14 days apart. Naltrexone, 50 mg Oral (Day -1, Day 1 and Day 2). All subjects will receive naltrexone block |
| PF614 capsule concomitantly with nafamostat and naltrexone HCl | Experimental | Drug: PF614 capsule, Drug: Nafamostat MesylatePF614 is an oxycodone prodrug. Part 1 doses = 100, 300 and up to 500 mg. Nafamostat Mesylate is a trypsin inhibitor that blocks PF614 activation. Nafamostat IR solution (0.75 - XX mg); Nafamostat ER beads in capsule formulation (0.25 - YY mg) Naltrexone, 50 mg Oral (Day -1, Day 1 and Day 2). All subjects will receive naltrexone block |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures.
- Must be willing and able to comply with all study requirements.
- Aged 18 to 55 years, inclusive, at time of signing informed consent.
- Must agree to use an adequate method of contraception (as defined in Section 9.4).
- Healthy males or non pregnant, non lactating healthy females.
Key exclusion criteria (32 listed)
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
- Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria.
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease (Part 1 only: except cholecystectomy), gastrointestinal surgery (e.g. gastric bypass, gastric banding, colectomy), or neurological or psychiatric disorder, as judged by the investigator.
- Subjects with a history of seizures.
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 |
|---|---|---|
| PF614 capsuleAlso: PRF06104, Oxycodone prodrugPF614 capsules (25-100 mg) | Drug | PF614 capsule concomitantly with nafamostat and naltrexone HCl, PF614 capsule with naltrexone HCl |
| Nafamostat MesylateAlso: FuthanNafamostat IR/ER solution/beads/powder (total 1-25 mg) | Drug | PF614 capsule concomitantly with nafamostat and naltrexone HCl |
Primary outcome
Pharmacokinetic Tmax [Time to Maximum Plasma Concentration]
Time frame: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Time to maximum observed concentrations of oxycodone following administration of PF614 alone and with nafamostat
Pharmacokinetic Cmax [Maximum Plasma Concentration]
Time frame: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Maximum (peak) observed concentration of oxycodone following administration of PF614 alone and with nafamostat
Pharmacokinetic C24 [Plasma concentration at 24 hours]
Time frame: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Concentration of oxycodone at 24 hours post-dose following administration of PF614 alone and with nafamostat
Pharmacokinetic AUC(0-last) [Area Under the Curve]
Time frame: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Area under the concentration-time curve from time 0 to the time of last measurable concentrations of oxycodone following administration of PF614 alone and with nafamostat
Pharmacokinetic AUC(0-inf) [Area Under the Curve]
Time frame: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Area under the concentration-time curve from time 0 extrapolated to time-infinity of oxycodone following administration of PF614 alone and with nafamostat
Pharmacokinetic T1/2 [Half-life]
Time frame: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.
Terminal elimination half-life concentrations of oxycodone following administration of PF614 alone and with nafamostat
1 secondary outcome
Incidence of Treatment-Emergent Adverse Effects [Safety and Tolerability]
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 41774070Kirkpatrick DL, Pestano LA, Evans C, Millard J, Levy J, Zann V, Pepper K, Schmidt WK. Formulation development and a Phase 1 clinical study of PF614-MPAR, an oxycodone prodrug with oral opioid overdose protection. J Opioid Manag. 2026 Jan-Feb;22(1):37-A26. doi: 10.5055/jom.0991.
- 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
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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.
Jeffrey Levy, MD, PhD principal investigator
Medical Director, Quotient Sciences
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 capsule and Nafamostat Mesylate in people with Pharmacokinetics and Healthy Volunteer, 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 7 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William K Schmidt, PhD (650-438-3018, wschmidt@ensysce.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Tmax [Time to Maximum Plasma Concentration] (time frame: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.). The study lists 6 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 NCT06500793, which also lists 3 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 26 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.