Open-Label Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2022-12-16
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective: To assess the safety and tolerability of EXPAREL administered as a single intrathecal injection in healthy volunteers.

Secondary Objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EXPAREL administered as a single intrathecal injection in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

1. Healthy adult male or female volunteers ages ≥18 and ≤50 years old.

2. American Society of Anesthesiologists physical status 1

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

Exclusion Criteria:

1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, NSAIDs, spinal anesthesia).

2. Impaired renal or hepatic function (e.g., serum creatinine level >2 mg/dL [176.8 µmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase level >1.5 times the upper limit of normal [ULN], or serum alanine aminotransferase level >1.5 times the ULN).

3. Subjects at an increased risk for bleeding or who have a coagulation disorder (defined as platelet count less than 80,000 × 103/mm3).

4. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which may confound the post dosing assessments.

5. Women of childbearing potential must have a documented negative pregnancy test at screening and must be confirmed on the day of drug administration. If postmenopausal, must have a documented follicle stimulating hormone test confirming menopause at screening.

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

7. Positive serology test result for human immunodeficiency virus, Hepatitis B virus, or Hepatitis C virus.

8. Clinically significant abnormal ECG that in the opinion of the investigator would preclude the subject from participation in the study.

9. Previous participation in a PACIRA study.

10. Use of systemic glucocorticosteroids and neuromodulating agents (e.g., gabapentin, pregabalin [Lyrica], duloxetine [Cymbalta] etc.) up to 3 days prior to study drug administration.

11. Opioid medications and NSAIDs are not permitted up to 3 days prior to study drug administration.

12. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

13. 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.