PACIRA 124

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Thank you for your interest in the study.

The Human Pharmacology & Physiology Lab (HPPL) is part of the Department of Anesthesiology at Duke. The lab is physically located within the Duke Early Phase Clinical Research Unit (DEPRU) in Duke Clinics.

You are being asked to take part in this research study because you are a healthy adult who is interested in being a participant in a clinical trial. The purpose of this study is to assess the safety and tolerability Liposomal Bupivacaine 13.3 (the study drug) given as a single intrathecal (spinal) injection, and to look at how the body reacts to the drug and how the drug works. The study drug is a liposome (surrounded in fat molecules) injection of bupivacaine, which is an FDA approved drug used for pain. Currently, liposomal bupivacaine is not FDA approved for intrathecal use so this would be considered an investigational use of this drug.

Bupivacaine numbs the body area around where it is administered, decreasing pain and other sensations. If you choose to participate, you will be placed into 1 of 3 groups (also referred to as "cohorts") in this study: Cohort 1, Cohort 2, and Cohort 3. Within each cohort, subjects will be randomized (chosen by chance- like a flip of a coin) into one of three subgroups with 6 subjects receiving Liposomal Bupivacaine 13.3 intrathecal (IT) injection, 6 subjects receiving bupivacaine IT injection, and 6 subjects receiving placebo IT injection. Cohort 1 will be completed before Cohort 2 begins. Cohort 2 will be completed before Cohort 3 begins.

If you choose to participate, you will stay in the Duke Early Phase Research Unit (DEPRU) for 6 days and 5 nights after the study drug administration, at which point you will be discharged. You will be asked to return to DEPRU 3 days after discharge for a follow-up visit. You will also receive a follow-up phone call on Day 30.

The study treatment will be given as a single injection into your spine. On the day of the drug administration, you will have several assessments done, including blood and urine samples. Additionally, you will provide 13 blood samples throughout your stay at DEPRU. . Other assessments include a 12-lead electrocardiogram (ECG) that measures your heart's electrical activity, a neurological questionnaire, sensory and motor tests, vital signs, and a comprehensive neurological assessment up to three hours before you receive the study drug. Risks of the study drug include spinal headache, restlessness, anxiety, blurred vision, ringing in the ears, and tremors. Risks of other study activities, like the blood draws, include skin irritation, site infection, and systemic infection.

You will not receive any immediate direct benefits from being in this study. However, we hope the knowledge obtained from the results of this study may be of benefit to you or others in the future. You do not have to participate in this study. This study is not designed to diagnose, treat, or prevent any disease. Your alternative is to not participate.

You will be compensated for your participation in the study.

Thank you again for your interest!

Record ID

First Name

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Last Name

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Date of Birth

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M-D-Y

Preferred Phone Number

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Preferred Email Address

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Preferred Method of Contact

Phone

How did you hear about this study?

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Referral

Facebook

Instagram

Flyer

Dukelist

AutoCruitment

Other

Gender

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Male

Female

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Ethic Origin

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Alaskan Native of American Indian

Asian

Black or African American

Native Hawaiians Pacific Islander

White

Other

Race

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Hispanic

Non-Hispanic

Height

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Weight

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BMI

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Are you currently taking any medications?

This includes prescribed medicines, over the counter (OTC) preparations, vitamins and health supplements, birth control and ADHD medications.

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Yes

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Have you participated in an investigational drug study (either at Duke or elsewhere) within the last 30 days?

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Yes

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Have you participated in a previous PACIRA study?

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Yes

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Do you smoke or chew tobacco? This includes cigarettes, cigars, & pipes.

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Yes

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Do you have a history of any significant heart or lung condition?

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Yes

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Do you have a known allergy or hypersensitivity reaction to local anesthetics, such as lidocaine, bupivacaine or novocaine?

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Yes

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Would you like to be added to our subject data base to be hear more about future studies?

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Yes

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Please feel free to view the informed consent form.

Attachment:ICF_29FEB2024_CR.pdf

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