drugset / Trial / NCT06500793
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)
Phase 1
Recruiting
54 enrolled
Ensysce Biosciences
National Institute on Drug Abuse (NIDA) · collabQuotient Sciences · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2024-11-24
- Primary completion
- 2026-12-22
- Completion
- 2027-04-28
Publications
- Background 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.
- 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 | 1 mg | — |
| Subject | Nafamostat | Small molecule | 10 mg | — |
| Subject | Nafamostat | Small molecule | 25 mg | — |
| Subject | PF614 | Unknown | 25 mg | — |
| Subject | PF614 | Unknown | 50 mg | — |
| Subject | PF614 | Unknown | 100 mg | — |
| Subject | PF614 | Unknown | 300 mg | — |
| Subject | PF614 | Unknown | 500 mg | — |
Indications
No indication recorded.