drugset / Trial / NCT05043766
Evaluation of Oral PF614 Relative to OxyContin (PF614-102)
RandomizedCrossoverOpen-labelTreatment
Summary
This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B). Both parts of the study will be conducted in healthy adult subjects.
Timeline
- Start
- 2021-09-08
- Primary completion
- 2022-03-21
- Completion
- 2022-03-21
Outcome
Met primary endpoint
release “Study PF614-102 found that PF614 conformed to the FDA bioequivalence acceptance criteria when compared to OxyContin under both fasted and fed conditions.” ensysce.com ↗
Publications
- 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxycodone | Other / unclassified | 20 mg | — |
| Comparator | Oxycodone | Other / unclassified | 40 mg | — |
| Comparator | Oxycodone | Other / unclassified | 80 mg | — |
| Subject | PF614 | Unknown | 50 mg | Oral |
| Subject | PF614 | Unknown | 100 mg | Oral |
| Subject | PF614 | Unknown | 200 mg | Oral |
| Background | Naltrexone | Small molecule | 50 mg | — |
Indications
No indication recorded.