402-C-124 (Study for Healthy Volunteers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if giving a drug called Exparel (the study drug) as a spinal injection is a safe and effective option for pain management. The study drug is approved to treat pain after surgery and is injected into the surrounding area where the surgery was done. We want to know if the study drug can also be given as an intrathecal (into the space surrounding the spine) injection to help control pain.

What is the Condition Being Studied?

Study to Test an Extended-Release Local Anesthetic

Who Can Participate in the Study?

Adults ages 18-50 who:

  • Are in general good health
  • Have the time to check into our clinic for 6 days and 5 nights
  • Have no medical conditions related to their kidneys, liver, or cardiovascular system
  • Have no history of frequently occurring headaches (migraines, cluster headache or tension headache)
  • Have no other pain-related conditions that require medication

For more information about who can join this study, contact the study team at 919-681-2849.

Age Group

What is Involved?

If you choose to join this study, you will:

  • Get a single spinal injection of the study drug
  • Have 4 lumbar punctures (spinal tap) to collect spinal fluid (CSF)
  • Check in to our clinic at Duke Hospital for a stay that lasts 6 days and 5 nights
  • Fill out questionnaires
  • Have sensory and motor assessments done
  • Have blood draws and give urine samples

We will pay study participants for their time.

To learn more about this study or let us know that you are interested, please visit our website:


Study Details

Full Title
A Phase 1, Double-Blind, Active- and Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered via a Single Intrathecal Injection to Healthy Volunteers
Principal Investigator
Protocol Number
IRB: PRO00112280
NCT: NCT05456490
Phase I
Enrollment Status
Open for Enrollment