drugset / Trial / NCT05090280
Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)
Phase 1
Completed
111 enrolled
Ensysce Biosciences
National Institute on Drug Abuse (NIDA) · collabQuotient Sciences · collab
RandomizedSequentialOpen-labelTreatment
Summary
A single dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is solution is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release (ER) capsule prototypes.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2023-04-26
- Completion
- 2023-04-26
Publications
- Background Kirkpatrick 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 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nafamostat | Small molecule | 10 mg | — |
| Subject | PF614 | Unknown | — | — |
| Background | Naltrexone | Small molecule | 50 mg | — |
Indications
No indication recorded.