Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629402
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test PF614-201
Sponsor:
None
Organization:
None
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:
No
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 wont 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 wont 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None