Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04173611 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers
A Phase 1 study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04173611: Clinical Trial Phase 1 study, sponsored by Pacira Pharmaceuticals.
NCT04173611 is a Phase 1 study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04173611, a Phase 1 study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Primary objective: To assess the safety and tolerability of EXPAREL® administered as a single intrathecal injection in healthy volunteers Secondary objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EXPAREL® administered as a single intrathecal injection in healthy volunteers
Primary Outcome
Pharmacokinetic endpoint
Interventions
- OTHER Placebo
- DRUG Bupivacaine Hydrochloride
- DRUG EXPAREL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 1 |
Why NCT04173611 stopped before completion
NCT04173611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04173611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04173611 about?
NCT04173611 is a clinical study titled "Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of EXPAREL® Administered Via a Single Intrathecal Injection to Healthy Volunteers". Primary objective: To assess the safety and tolerability of EXPAREL® administered as a single intrathecal injection in healthy volunteers Secondary objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EXPAREL® administered as a single intrathecal injection in heal...
What is the current status of trial NCT04173611?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-06-08. Estimated completion is 2020-12-07.
What interventions are being tested in trial NCT04173611?
The interventions under investigation include: Placebo (OTHER), Bupivacaine Hydrochloride (DRUG), EXPAREL (DRUG).
Who is sponsoring clinical trial NCT04173611?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04173611's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI