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

ConditionsPharmacokineticsHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEnsysce Biosciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • PF614 capsule

    Drug

    PF614 capsules (25-100 mg)

  • Nafamostat Mesylate

    Drug

    Nafamostat IR/ER solution/beads/powder (total 1-25 mg)

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: PF614 capsule with naltrexone HClExperimental treatment 1 intervention
Group B: PF614 capsule concomitantly with nafamostat and naltrexone HClExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pharmacokinetic Tmax [Time to Maximum Plasma Concentration]

Time to maximum observed concentrations of oxycodone following administration of PF614 alone and with nafamostat

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

Pharmacokinetic Cmax [Maximum Plasma Concentration]

Maximum (peak) observed concentration of oxycodone following administration of PF614 alone and with nafamostat

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

Pharmacokinetic C24 [Plasma concentration at 24 hours]

Concentration of oxycodone at 24 hours post-dose following administration of PF614 alone and with nafamostat

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

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

Time frame
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.

Time frame
30 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ensysce Biosciences

Lead sponsor

Quotient Sciences

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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