NCT00485667

Phase 1 Thorough QT Study in Young Healthy Volunteers

Evaluation of the Effects of Therapeutic and Supra-therapeutic Single Doses of SKY0402 Given as Subcutaneous Injection on the QT/QTc Interval in Young Healthy Volunteers. A Prospective, Randomized, Placebo- and Positive-controlled, Double Blind, Single-centre, Crossover Phase 1 Study.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction.

Detailed description

Providing extended pain relief without the use of indwelling catheters is the basis for developing SKY0402. A formulation of bupivacaine, given as a single injection after surgery, that could provide adequate, continuous, and extended pain relief would greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize break-through episodes of pain.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	SKY0402	Subects received either 300mg or 450mg
DRUG	Moxifloxacin 400mg
DRUG	Placebo injection
DRUG	Placebo tablet

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2007-06-13
• Last updated: 2021-02-16

Locations

1 site across 1 country: United Kingdom