Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574269
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
A Study on TLC590 for Managing Postsurgical Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-label Dose-escalation Study to Evaluate Pharmacokinetics Pharmacodynamics Bioavailability Safety and Tolerability of TLC590 in Multiple Surgical Models
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This Phase 2 open-label trial investigates the pharmacokinetics PK pharmacodynamics and safety profile of TLC590 across various surgical procedures Researchers aim to determine the maximum tolerated dose MTD of TLC590 via Safety Monitoring Committee SMC
The study evaluates TLC590 in bunionectomy laparoscopy-assisted open ventral hernia repair breast augmentation abdominoplasty and total knee arthroplasty models Additionally it determines the relative bioavailability of TLC590 to ropivacaine injection
The study evaluates TLC590 in bunionectomy laparoscopy-assisted open ventral hernia repair breast augmentation abdominoplasty and total knee arthroplasty models Additionally it determines the relative bioavailability of TLC590 to ropivacaine injection
Detailed Description:
This Phase 2 open-label multi-center study is a 3-part study to be performed in approximately 120 subjects undergoing multiple surgical procedures receiving TLC590 or ropivacaine injection Subjects eligible based on inclusion and exclusion criteria will receive study drug administered via infiltration Subjects entering all parts of the study will undergo the consent and screening procedures eligibility requirements and PK and safety evaluations during their participation in the study
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