402-C-124 (Study for Healthy Volunteers)

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:<ul>
<li>Are in general good health</li>
<li>Have the time to check into our clinic for 6 days and 5 nights</li>
<li>Have no medical conditions related to their kidneys, liver, or cardiovascular system</li>
<li>Have no history of frequently occurring headaches (migraines, cluster headache or tension headache)</li>
<li>Have no other pain-related conditions that require medication</li></ul>
For more information about who can join this study, contact the study team at 919-681-2849.

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?

If you choose to join this study, you will:<ul>
<li>Get a single spinal injection of the study drug</li>
<li>Have 4 lumbar punctures (spinal tap) to collect spinal fluid (CSF)</li>
<li>Check in to our clinic at Duke Hospital for a stay that lasts 6 days and 5 nights</li>
<li>Fill out questionnaires</li>
<li>Have sensory and motor assessments done</li>
<li>Have blood draws and give urine samples</li></ul>
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: <a href="https://redcap.duke.edu/redcap/surveys/?s=XAAKKE8YJ98X7XYL">https://redcap.duke.edu/redcap/surveys/?s=XAAKKE8YJ98X7XYL</a>

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

Principal Investigator

David
MacLeod

Protocol Number

PRO00112280

NCT ID

NCT05456490

Phase

I

Enrollment Status

Open to Enrollment