EXPAREL for Healthy Subjects (HS)
Phase-Based Progress Estimates
Effectiveness
Safety
Duke University, Durham, NC
Healthy Subjects (HS)
EXPAREL - DrugEligibility
18 - 65
All Sexes
What conditions do you have?
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Eligibility
18 - 65
All Sexes
What conditions do you have?
Select
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
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
Side Effects for
EXPAREL
8%pyrexia
8%rash
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: DrugEXPAREL 3mL (39.9 mg)
Drug
Experimental Group · 1 Intervention: EXPAREL · Intervention Types: DrugTreatment
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
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 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.
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Conditions
Cancer Related
Treatments