Liposomal Bupivacaine for Healthy Volunteers

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Pacira Pharmaceuticals, Inc

Trial Summary

What is the purpose of this trial?

This trial tests a new slow-release pain-relief drug called Liposomal Bupivacaine 13.3 in healthy adults to ensure it is safe and well-tolerated. Liposomal bupivacaine is designed to provide extended postsurgical pain relief and reduce opioid consumption.

Research Team

Sergey Zaets

Principal Investigator

Pacira Pharmaceuticals, Inc

Eligibility Criteria

Healthy adults aged 18-50, with no history of severe headaches, back conditions, or chronic pain. Participants must not have allergies to study medications like bupivacaine and should not be on certain medications like corticosteroids before the trial. Women must not be pregnant or nursing.

Inclusion Criteria

I am between 18 and 50 years old and in good health.

American Society of Anesthesiologists physical status 1

Able to provide informed consent, adhere to the study schedule, and complete all study assessments

Exclusion Criteria

I have a bleeding risk or a blood clotting disorder with low platelets.

I am not allergic or intolerant to the study's medications.

Currently pregnant, nursing, or planning to become pregnant during the study

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Treatment Details

Interventions

Liposomal Bupivacaine 13.3 (Local Anesthetic)

Trial OverviewThe safety and effects of Liposomal Bupivacaine 13.3 are being tested when given as a single spinal injection to healthy volunteers. The trial will also measure how the drug moves through and affects the body.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Liposomal Bupivacaine 13.3Experimental Treatment1 Intervention

Cohort 1 subjects will be dosed 2 mL (26.6 mg) of Liposomal Bupivacaine 13.3. Cohort 2 subjects randomized to the Liposomal Bupivacaine 13.3 arm will be dosed 3 mL (39.9 mg) of Liposomal Bupivacaine 13.3. Cohort 3 subjects randomized to the Liposomal Bupivacaine 13.3 arm will be dosed 4 mL (53.2 mg) of Liposomal Bupivacaine 13.3.

Group II: Bupivacaine ITActive Control1 Intervention

Cohort 1 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg/ 1 mL) of 0.75% bupivacaine. Cohort 2 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg/ 1 mL) of 0.75% bupivacaine mixed with 1 mL of preservative free normal saline to create a total volume of solution administered of 3 mL. Cohort 3 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg / 1 mL) of 0.75% bupivacaine mixed with 2 mL of preservative free normal saline to create a total volume of solution administered of 4 mL.

Group III: PlaceboPlacebo Group1 Intervention

Cohort 1 subjects randomized to the placebo arm will be dosed 2 mL of preservative free normal saline. Cohort 2 subjects randomized to the placebo arm will be dosed 3 mL of preservative free normal saline. Cohort 3 subjects randomized to the placebo arm will be dosed 4 mL of preservative free normal saline.