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NCT05456490 · ClinicalTrials.gov registry record · Phase 1
Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13.3 Administered Via a Single Intrathecal Injection to Healthy Volunteers
A Phase 1 study of Healthy, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT05456490: Completed Phase 1 study of Healthy, sponsored by Pacira Pharmaceuticals.
NCT05456490 is a Phase 1 study of Healthy that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 54 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05456490, a Phase 1 study of Healthy, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To assess the safety and tolerability of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers. Secondary Objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers.
Primary Outcome
Pharmacokinetic Endpoint
Conditions Studied
Interventions
- DRUG Bupivacaine
- OTHER Placebo
- DRUG Liposomal Bupivacaine 13.3
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-04-18 |
| Est. Completion | 2025-02-27 |
| Phase | Phase 1 |
What the finished NCT05456490 record still lists
NCT05456490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Bupivacaine is the first listed.
NCT05456490 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05456490 about?
NCT05456490 is a clinical study titled "Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13.3 Administered Via a Single Intrathecal Injection to Healthy Volunteers". Primary Objective: To assess the safety and tolerability of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers. Secondary Objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Liposomal Bupivacaine 13.3 administered as a...
What is the current status of trial NCT05456490?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2023-04-18. Estimated completion is 2025-02-27.
What conditions does trial NCT05456490 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05456490?
The interventions under investigation include: Bupivacaine (DRUG), Placebo (OTHER), Liposomal Bupivacaine 13.3 (DRUG).
Who is sponsoring clinical trial NCT05456490?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05456490 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05456490's enrollment target sits among peer trials
54 433rd of 1090 higher than 653 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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