Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers (TTO)

A Phase 1 Randomized, Single-blind, Sequential Cohort, Crossover Study to Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers

Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and extended pain relief that could greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize episodes of breakthrough pain.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Drug: Placebo; Drug: SKY0402

Detailed Description

Subjects will be given either SKY0402 or placebo in response to a noxious stimulus, and the time to onset will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210-1239
      • The Ohio State University College of Medicine, Dept of Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects eligible for study entry will meet the following criteria:

• Male or female, ages at least 18 years and not over 55 years.
• Body mass index (BMI) within the range 20.0 to 30.0 kg/m2, inclusive.
• Applies to females only: Female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device beginning > 30 days prior to the first dosing and continuing until > 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for > 1 year if they wish not to use contraceptives.
• Good general health, evidenced by a lack of significantly abnormal findings on medical history and screening assessments.
• Pain intensity score of > 30 mm on a VAS after incision and application of an 18% acetic acid solution to nontreated skin (i.e., not infiltrated with any test or control article) at Screening.
• Able and willing to comply with all study visits and procedures, including returning as scheduled for the second treatment visit.
• Able to speak, read, and understand the language of the ICF, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments.
• Willing and capable of providing written informed consent.

Exclusion Criteria:

A subject will not be eligible for the study if he or she meets any of the following criteria:

• A history of hypersensitivity to amide type local anesthetics.
• Pregnancy, nursing, or planning to become pregnant during the course of the study.
• Any current conditions that might interfere with pain assessments, including current pain.
• Conditions of the skin or neurological abnormalities that might alter pain sensitivity. These include excessive scarring, burns, skin grafts, and trauma. Tattoos are permitted.
• A history of keloid formation.
• A coagulopathy or use of medications that might enhance bleeding.

• Use of any of the following medication within the times specified before study drug administration:

  • Long-acting opioid mediations within 3 days.
  • Any opioid medication within 24 hours.
  • Any analgesic medication within 12 hours.
• Consumption of alcohol within 24 hours before either treatment visit.
• Any condition that, in the opinion of the Investigator, renders a subject unsuitable for participation in the study. NOTE: The specific reason(s) for exclusion will be documented in the Screening Log.
• Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

Minor deviations in eligibility criteria are permitted if approved by the Pacira Medical Monitor in agreement with the Investigator prior to dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Local administration of Placebo followed by noxious stimuli
Experimental: SKY0402	Drug: SKY0402; Local administration of SKY0402 followed by noxious stimulus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to onset of action	15 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
time to onset	bewteen 15 and 30 minutes

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc
• Investigators: Study Director: Marius Ardeleanu, MD, Pacira Pharmaceuticals, Inc

Publications and helpful links

General Publications

• Apseloff G, Onel E, Patou G. Time to onset of analgesia following local infiltration of liposome bupivacaine in healthy volunteers: a randomized, single-blind, sequential cohort, crossover study. Int J Clin Pharmacol Ther. 2013 May;51(5):367-73. doi: 10.5414/CP201775.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (Estimate): December 11, 2008

Study Record Updates

• Last Update Posted (Estimate): September 6, 2010
• Last Update Submitted That Met QC Criteria: August 31, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: postoperative; pain management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SKY0402C109