Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy

• Sponsor: Pacira Pharmaceuticals, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02199574
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Duration (Months): 10
• Patients Per Site: 6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the pharmacokinetic (PK) profile of a single dose of EXPAREL (133 mg/10 mL) administered intraoperatively per normal infiltration for prolonged analgesia in 12 adult subjects undergoing tonsillectomy with or without removal of the adenoids.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: EXPAREL	Phase 4

Detailed Description

Blood samples for bupivacaine PK analysis will be obtained from subjects at baseline (within 30 minutes prior to EXPAREL infiltration), 15 minutes, 30 minutes, and 1, 2, 4, 8, 12, 24, 36, 48, and 72 hours after the beginning of EXPAREL infiltration, and on Day 7.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetic Evaluation of EXPAREL in Adults Undergoing Tonsillectomy
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EXPAREL Single administration of EXPAREL 133 mg (10 mL).	Drug: EXPAREL; 133 mg EXPAREL in 10 mL.; Other Names: bupivacaine liposome injectable suspension

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration (Cmax) [From time of study drug administration through Day 7 postdose]

2. Time to Maximum Plasma Concentration (Tmax) [From time of study drug administration through Day 7 postdose]

3. Area Under the Plasma Concentration Versus Time Curve (AUC(0-t)) [From time of study drug administration through Day 7 postdose]

4. Apparent Terminal Elimination Half-life [From time of study drug administration through Day 7 postdose]

5. Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity)) [From time of study drug administration through Day 7 postdose]

6. The Apparent Terminal Elimination Rate Constant (λz) [From time of study drug administration through Day 7 postdose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, ≥18 years of age at the Screening Visit.

• Subjects undergoing tonsillectomy with or without removal of the adenoids.

• Able and willing to comply with all study visits and procedures.

• Willing and capable of providing written informed consent.

Exclusion Criteria:

• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.

• Received any investigational drug within 30 days prior to EXPAREL administration, and/or has planned administration of another investigational product or procedure while participating in this study.

• Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after EXPAREL administration. Female subjects must be surgically sterile, at least 2 years postmenopausal, or using an acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before EXPAREL administration.

• Subjects with significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to EXPAREL and/or procedures, or cause inability to comply with the study requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Hermann - Memorial City Medical Center	Houston	Texas	United States	77024
2	Memorial Village Surgery Center	Houston	Texas	United States	77024

Sponsors and Collaborators

• Pacira Pharmaceuticals, Inc

Investigators

• Principal Investigator: Harold Minkowitz, MD, Herman Memorial Hospital, Houston TX

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT02199574
• Other Study ID Numbers: 402-C-401
• First Posted: Jul 24, 2014
• Last Update Posted: Mar 8, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Bupivacaine

Study Results

Participant Flow

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL.
Overall Participants	12
Age (Count of Participants)
<=18 years	1 8.3%
Between 18 and 65 years	11 91.7%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.6 (13.30)
Sex: Female, Male (Count of Participants)
Female	6 50%
Male	6 50%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Plasma Concentration (Cmax)
Time Frame	From time of study drug administration through Day 7 postdose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL: 133 mg EXPAREL in 10 mL.
Measure Participants	11
Mean (Standard Deviation) [ng/mL]	254 (82.6)

2. Primary Outcome

Title	Time to Maximum Plasma Concentration (Tmax)
Time Frame	From time of study drug administration through Day 7 postdose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL.
Measure Participants	11
Median (Full Range) [hours]	0.50

3. Primary Outcome

Title	Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))
Time Frame	From time of study drug administration through Day 7 postdose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL.
Measure Participants	11
Mean (Standard Deviation) [hours*ng/mL]	7150 (3189)

4. Primary Outcome

Title	Apparent Terminal Elimination Half-life
Time Frame	From time of study drug administration through Day 7 postdose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL.
Measure Participants	3
Mean (Standard Deviation) [hours]	9.34 (2.31)

5. Primary Outcome

Title	Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))
Time Frame	From time of study drug administration through Day 7 postdose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL
Measure Participants	3
Mean (Standard Deviation) [hours*ng/mL]	6379 (2825)

6. Primary Outcome

Title	The Apparent Terminal Elimination Rate Constant (λz)
Time Frame	From time of study drug administration through Day 7 postdose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL
Measure Participants	3
Mean (Standard Deviation) [1/hours]	0.07779 (0.02222)

Adverse Events

Arm/Group Title	EXPAREL
Arm/Group Description	Single administration of EXPAREL 133 mg (10 mL). EXPAREL
All Cause Mortality
	EXPAREL
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	EXPAREL
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	EXPAREL
	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)
General disorders
pyrexia	1/12 (8.3%)	1
Skin and subcutaneous tissue disorders
rash	1/12 (8.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.