Overview

Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers

Status:
Terminated
Trial end date:
2020-12-07
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
Treatments:
Bupivacaine
Criteria
Inclusion Criteria:

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

2. American Society of Anesthesiologists (ASA) 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 (eg, amide-type
local anesthetics, opioids, bupivacaine, non-steroidal anti-inflammatory drugs
[NSAIDs], spinal anesthesia).

2. Impaired renal or hepatic function (eg, serum creatinine level >2 mg/dL [176.8
μmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate
aminotransferase [AST] level >1.5 times the upper limit of normal [ULN], or serum
alanine aminotransferase [ALT] 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 (FSH) test confirming menopause at
screening.

6. Currently pregnant, nursing, or planning to become pregnant during the study or within
30 days after completion of the study.

7. Positive serology test result for Human Immunodeficiency Virus (HIV), 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. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription
medicine(s), or alcohol within the past 2 years.

11. 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