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
Ensysce Biosciences
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.
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 ab…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures. 2. Must be willing and able to comply with all study requirements. 3. Aged 18 to 55 years, inclusive, at time of signing informed consent. 4. Must agree to use an adequate method of contraception (as defined in Section 9.4). 5. Healthy males or non pregnant, non lactating healthy females. 6. 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. 7. Minimum…
Interventions
- DrugPF614 capsule
PF614 capsules (25-100 mg)
- DrugNafamostat Mesylate
Nafamostat IR/ER solution/beads (total 1-10 mg)
Location
- Quotient SciencesMiami, Florida