Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Single and Multi-Dose Study Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat PF614-MPAR-102
Sponsor:
Ensysce Biosciences
Organization:
Ensysce Biosciences
Study Overview
Official Title:
A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered with Nafamostat As a Combination IR Solution and ER Capsule Formulation in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A single and multiple-dose dose study to assess the pharmacokinetics PK of oxycodone when PF614 is administered alone and with nafamostat as an immediate-release IR solution andor extended-releaseER capsule prototypes
Detailed Description:
PF614-MPAR is a combination of an oxycodone prodrug PF614 and a protease inhibitor nafamostat that is intended to provide overdose protection when more than a prescribed dose may be taken simultaneously A previous study QSC203698 has explored various nafamostat formulations and identified an optimal combination of immediate release IR nafamostat and an extended release ER bead that when co-administered with 25 mg PF614 does not impact oxycodone exposure However when administered in an overdose situation 8 x unit dose level 200 mg PF614 and 8 mg nafamostat the nafamostat was able to inhibit trypsin which prevented the conversion of PF614 to oxycodone and hence prevented increased exposure of oxycodone when compared to 200 mg PF614 in the absence of nafamostat The nafamostat formulation for the PF614 25 mg dose unit was identified 1 mg total nafamostat comprised of 075 mg IR and 025 mg ER beads 8020 coating ratio Ultimately the study defined the PF614-MPAR 25 mg dose unit
Part 1 of the current study aims to define the PF614-MPAR 100 mg dose unit that is intended for commercialization by exploring the impact of nafamostat on release of oxycodone from PF614 in naltrexone blocked healthy volunteers Exposure of both oxycodone and PF614 will be evaluated following administration of 100 mg PF614-MPAR PF614 and nafamostat 1 mg as single dose unit or when administered up to 5 dose units simultaneously If the nafamostat dose needs adjusting with 100 mg PF614 then this will also be assessed with the 50 mg PF614 dose unit in optional Part 1b Part 1 will also assess exposure of a new 100 mg PF614 capsule formulation In Part 2 the food effect will be assessed at the highest PF614 and nafamostat dose If Part 1 is able to identify an appropriate PF614-nafamostat ratio then optional Part 3 will proceed which will investigate multiple dosing twice a day dosing BID for 45 days of 25 mg and 100 mg PF614-MPAR optimized doses units PF614 administered with the selected nafamostat unit dose or PF614 alone to naltrexone blocked healthy volunteers in the fasted state
The current study proposes to dose up to 500 mg PF614 equivalent to 200 mg oxycodone the 50 mg daily doses of naltrexone are anticipated to be more than sufficient to block 200 mg of an oxycodone-equivalent exposure
Part 1 of the current study aims to define the PF614-MPAR 100 mg dose unit that is intended for commercialization by exploring the impact of nafamostat on release of oxycodone from PF614 in naltrexone blocked healthy volunteers Exposure of both oxycodone and PF614 will be evaluated following administration of 100 mg PF614-MPAR PF614 and nafamostat 1 mg as single dose unit or when administered up to 5 dose units simultaneously If the nafamostat dose needs adjusting with 100 mg PF614 then this will also be assessed with the 50 mg PF614 dose unit in optional Part 1b Part 1 will also assess exposure of a new 100 mg PF614 capsule formulation In Part 2 the food effect will be assessed at the highest PF614 and nafamostat dose If Part 1 is able to identify an appropriate PF614-nafamostat ratio then optional Part 3 will proceed which will investigate multiple dosing twice a day dosing BID for 45 days of 25 mg and 100 mg PF614-MPAR optimized doses units PF614 administered with the selected nafamostat unit dose or PF614 alone to naltrexone blocked healthy volunteers in the fasted state
The current study proposes to dose up to 500 mg PF614 equivalent to 200 mg oxycodone the 50 mg daily doses of naltrexone are anticipated to be more than sufficient to block 200 mg of an oxycodone-equivalent exposure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None