drugset / Trial / NCT05567354
A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103)
RandomizedCrossoverTriple-blindTreatment
Summary
The purpose of this study is to examine the abuse potential and pharmacokinetics of PF614 compared with a non-abuse deterrent, commercially available, immediate release (IR) oxycodone hydrochloride (HCl) formulation and placebo.
Timeline
- Start
- 2022-06-10
- Primary completion
- 2022-08-31
- Completion
- 2022-08-31
Outcome
Met primary endpoint
release “PF614 powder produced significantly lower peak "drug liking" (Emax) when compared with intranasal crushed IR oxycodone (p = 0.0133)” ensysce.com ↗
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 |
|---|---|---|---|---|
| Comparator | Oxycodone | Other / unclassified | 40 mg | — |
| Subject | PF614 | Unknown | 100 mg | Intranasal |
Indications
No indication recorded.