NCT05043766

Evaluation of Oral PF614 Relative to OxyContin (PF614-102)

A Phase 1b, Randomized 2-Part Single-Center Study to Evaluate the PK and Safety of Multiple Ascending Oral Doses of PF614 and the Food Effect and BA/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Ensysce Biosciences · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is intended to evaluate the pharmacokinetics of OxyContin (oxycodone ER) and PF614, as well as PF614 fragments, following administration of multiple ascending doses of PF614, and to compare to steady-state pharmacokinetics to those of OxyContin. (Part A) In addition, oral bioavailability of oxycodone derived from single doses of PF614 of the to-be-marketed capsule formulation will be compared to that of the reference drug, OxyContin, in the fasted and fed condition. A pivotal food effect assessment will be incorporated into the study to determine the impact of a high fat meal on the bioavailability of oxycodone, following oral single-dose administration of PF614 (Part B).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PF614	PF614 is an oxycodone prodrug
DRUG	Naltrexone Hydrochloride	Naltrexone HCl tablets, 50 mg, will be used to block the opioid effects in healthy volunteers
DRUG	OxyContin	Bioequivalence single-dose comparison to OxyContin

Timeline

• Start date: 2021-09-08
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2021-09-14
• Last updated: 2024-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study