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.

Pacira Pharmaceuticals, Inc1 site in 1 country48 target enrollmentJune 2007

ConditionsPostoperative Pain

InterventionsSKY0402 Moxifloxacin 400mg Placebo injection Placebo tablet

DrugsSKY0402 Moxifloxacin 400mg Placebo injection Placebo tablet

Overview

Phase: Phase 1
Intervention: SKY0402
Conditions: Postoperative Pain
Sponsor: Pacira Pharmaceuticals, Inc
Enrollment: 48
Locations: 1
Primary Endpoint: ECG findings using the best heart rate correction method
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

August 2007

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pacira Pharmaceuticals, Inc

Eligibility Criteria

Inclusion Criteria

•Healthy adult Caucasian men or non-pregnant, non-lactating women between 18 and 40 years of age, inclusive.
•Healthy as judged by responsible physician with no clinically significant abnormality identified on the medical and laboratory evaluation, including 12-lead ECG and vital signs.
•Non-smoker in the previous 3 months.
•Body weight greater than or equal to 50 kg and BMI within the range 19-29 kg/m2, inclusive.
•At screening and Run-in period each ECG should have:
•Consistent sinus rhythm, (i.e. if greater than or equal to 2 ECGs are not sinusal at different time points the volunteer should not be included),
•No clinically significant conduction disorder,
•PR between 120 and 230 ms,
•HR less than or equal to 100 beats/min and greater than or equal to 40 beats/min,
•QRS \< 120 ms,

Exclusion Criteria

•History or presence of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
•History of clinically significant syncope.
•Family history of sudden death.
•Family history of premature cardiovascular death.
•Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome.
•History of clinically significant arrhythmias (especially ventricular arrhythmias, atrial fibrillation, or recent conversion from atrial fibrillation).
•Complete bundle branch block / sinus node dysfunction.
•Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa).
•Any pathology or abnormality with possible influence on the ECGs.
•Clinically significant dermatological disease including history of drug-induced skin rash.