EXPAREL for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Duke University, Durham, NC
Healthy Subjects (HS)
EXPAREL - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new pain medication given as a single injection into the spinal fluid. The goal is to see if it is safe and tolerated by healthy volunteers, and to understand how it works in the body. The study drug, EXPAREL, is given to Healthy Subjects to treat them. This study drug has been previously approved by the FDA to treat a different condition. However, in this trial, no patients will receive a placebo. Instead, this treatment is free.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

6 Primary · 2 Secondary · Reporting Duration: 6-8 weeks

6-8 weeks
Apparent clearance (CL/F)
Apparent volume of distribution (Vd)
Area under the plasma concentration-versus-time curve (AUC0-last and AUC0- ∞)
Average duration of sensory block and motor block
Average time to onset of sensory block and motor block
Incidence of treatment-emergent AEs (TEAEs) through Day 9
Maximum plasma concentration (Cmax)
Proportion of subjects who have any of the neurological events.
The apparent terminal elimination half-life (t1/2el)
Time of Cmax (Tmax)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Side Effects for

EXPAREL
8%pyrexia
8%rash
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02199574) in the EXPAREL ARM group. Side effects include: pyrexia with 8%, rash with 8%.

Trial Design

2 Treatment Groups

EXPAREL 4 mL (53.2mg)
1 of 2
EXPAREL 3mL (39.9 mg)
1 of 2
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: EXPAREL · No Placebo Group · Phase 1

EXPAREL 4 mL (53.2mg)
Drug
Experimental Group · 1 Intervention: EXPAREL · Intervention Types: Drug
EXPAREL 3mL (39.9 mg)
Drug
Experimental Group · 1 Intervention: EXPAREL · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EXPAREL
2014
Completed Phase 4
~1160

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-8 weeks
Closest Location: Duke University · Durham, NC
Photo of Duke University Medical Center 1Photo of nc duke university 2Photo of nc duke university 3
2004First Recorded Clinical Trial
7 TrialsResearching Healthy Subjects (HS)
532 CompletedClinical Trials

Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor
87 Previous Clinical Trials
9,769 Total Patients Enrolled
3 Trials studying Healthy Subjects (HS)
94 Patients Enrolled for Healthy Subjects (HS)
Matt Mandel, MDStudy DirectorPacira Pharmaceuticals, Inc

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to provide informed consent, adhere to the study schedule, and complete all study assessments.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.