Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-12 @ 4:06 AM
Study NCT ID:
NCT06629402
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)
Sponsor:
Ensysce Biosciences
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2024-10
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:
CPT
Brief Summary:
The primary objective of the study is to evaluate the onset of analgesia following administration of a single oral dose of PF614 (50 mg or 100 mg) or placebo in healthy male subjects in an experimental pain model (cold pressor test \[CPT\]).
Detailed Description:
Researchers will compare drug PF614 to a placebo (a look-alike substance that contains no drug) to see if drug PF614 works to prevent moderate-to-severe experimental pain.
Study subjects will:
* On the Screening Day: Immerse their non-dominant hand in an ice cold water bath to assess their baseline pain threshold. Subjects will report when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes).
* On Treatment Day 1: Repeat the initial CPT test for pain, then take drug PF614 or a placebo capsule (the study will be blinded so they won't know which treatment they received). After taking a single dose of study medication, they will be tested again for when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes) at 10 time periods up to 6 hours after taking the study medications.
* Report adverse events, if any.
* On Treatment Day 2: After a minimum of 5 days after Treatment Day 1, subjects will repeat the procedures from Treatment Day 1. They will receive the opposite medication that they received on Treatment Day 1 (this is a cross-over design). They will be tested again for when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes) at 10 time periods up to 6 hours after taking the study medications.
* Report adverse events, if any.
Study subjects will:
* On the Screening Day: Immerse their non-dominant hand in an ice cold water bath to assess their baseline pain threshold. Subjects will report when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes).
* On Treatment Day 1: Repeat the initial CPT test for pain, then take drug PF614 or a placebo capsule (the study will be blinded so they won't know which treatment they received). After taking a single dose of study medication, they will be tested again for when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes) at 10 time periods up to 6 hours after taking the study medications.
* Report adverse events, if any.
* On Treatment Day 2: After a minimum of 5 days after Treatment Day 1, subjects will repeat the procedures from Treatment Day 1. They will receive the opposite medication that they received on Treatment Day 1 (this is a cross-over design). They will be tested again for when they first feel pain (onset) and how long they can keep their hand immersed in ice-cold water (maximum = 3 minutes) at 10 time periods up to 6 hours after taking the study medications.
* Report adverse events, if any.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: