RecruitingPhase 1

Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)

United States54 participantsStarted 2024-11-24

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetic Tmax [Time to Maximum Plasma Concentration]

Timeframe: 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]

Timeframe: 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]

Timeframe: 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]

Timeframe: 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]

Timeframe: 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]

Timeframe: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.

Trial details

NCT IDNCT06500793

SponsorEnsysce Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-22

Contact for this trial

William K Schmidt, PhD

650-438-3018 wschmidt@ensysce.com

View on ClinicalTrials.gov More Pharmacokinetics trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

What they're measuring

Pharmacokinetic Tmax [Time to Maximum Plasma Concentration]

Timeframe: 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]

Timeframe: 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]

Timeframe: 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]

Timeframe: 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]

Timeframe: 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]

Timeframe: Parts 1, 2, & 3 (PF614 single dose): predose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, 72 hours.