CompletedPhase 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

United States54 participantsStarted 2023-04-18

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy adult male or female volunteers ages ≥18 and ≤50 years old.
. American Society of Anesthesiologists physical status 1
. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.

Exclusion criteria

. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, NSAIDs, spinal anesthesia).
. Impaired renal or hepatic function (e.g., serum creatinine level \>2 mg/dL \[176.8 µmol/L\], blood urea nitrogen level \>50 mg/dL \[17.9 mmol/L\], serum aspartate aminotransferase level \>1.5 times the upper limit of normal \[ULN\], or serum alanine aminotransferase level \>1.5 times the ULN).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the plasma concentration-versus-time curve (AUC0-last and AUC0- ∞)

Timeframe: 7-8 weeks

Maximum plasma concentration (Cmax)

Timeframe: 7-8 weeks

Time of Cmax (Tmax)

Timeframe: 7-8 weeks

The apparent terminal elimination half-life (t1/2el)

Timeframe: 7-8 weeks

Apparent clearance (CL/F)

Timeframe: 7-8 weeks

Apparent volume of distribution (Vd)

Timeframe: 7-8 weeks

Trial details

NCT IDNCT05456490

SponsorPacira Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-27

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy adult male or female volunteers ages ≥18 and ≤50 years old.
. American Society of Anesthesiologists physical status 1
. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.

Exclusion criteria

. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, NSAIDs, spinal anesthesia).
. Impaired renal or hepatic function (e.g., serum creatinine level \>2 mg/dL \[176.8 µmol/L\], blood urea nitrogen level \>50 mg/dL \[17.9 mmol/L\], serum aspartate aminotransferase level \>1.5 times the upper limit of normal \[ULN\], or serum alanine aminotransferase level \>1.5 times the ULN).

What they're measuring

Area under the plasma concentration-versus-time curve (AUC0-last and AUC0- ∞)

Timeframe: 7-8 weeks

Maximum plasma concentration (Cmax)

Timeframe: 7-8 weeks

Time of Cmax (Tmax)

Timeframe: 7-8 weeks

The apparent terminal elimination half-life (t1/2el)

Timeframe: 7-8 weeks

Apparent clearance (CL/F)

Timeframe: 7-8 weeks

Apparent volume of distribution (Vd)

Timeframe: 7-8 weeks