drugset / Trial / NCT02454712
Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)
RandomizedSingle-groupOpen-labelTreatment
Summary
PF614 is an oxycodone prodrug that is designed for extended-release of oxycodone comparable to OxyContin. This Single Ascending Dose (SAD) study is designed to assess the safety and pharmacokinetics (PK) of PF614 in comparison to standard doses of OxyContin.
Timeline
- Start
- 2016-11-16
- Primary completion
- 2018-01-18
- Completion
- 2018-01-18
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.
- Results Schmidt WK, Dickerson DS, Fisher DM, Kirkpatrick DL. First-in-human pharmacokinetics & safety study of PF614: orally activated oxycodone prodrug. Anesth Analg. 2017;124(5):752-753.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 50 mg | — |
| Comparator | Oxycodone | Other / unclassified | 10 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 20 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 40 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 80 mg | Oral |
| Subject | PF614 | Unknown | 15 mg | Oral |
| Subject | PF614 | Unknown | 640 mg | Oral |
Indications
No indication recorded.