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.
Who Can Participate?
Eligibility
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
Age Range
18-50
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
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
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Study Website
Principal Investigator
David
MacLeod
Protocol Number
PRO00112280
NCT ID
NCT05456490
Phase
I
Enrollment Status
Open to Enrollment