Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects

NCT04158102 | Completed Phase 1 FDA Drug

• 1 other identifier: NB-EXP-1001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• plasma concentration

  Maximum observed plasma concentration (Cmax)

  up to 14 days

• Area under the plasma concentration-versus-time curve

  Area under the plasma concentration-versus-time curve from time 0 extrapolated to infinity after drug administration (AUC0-∞)

  up to 14 days

Secondary Outcomes (1)

• Incidence of adverse events（AEs）which are related to exparel injection

  up to 21 days

Study Arms (1)

20 mg single dose cohort

EXPERIMENTAL

Subjects would receive a 20 mg single dose of EXPAREL®

Drug: Bupivacaine liposome injectable suspension

Interventions

Bupivacaine liposome injectable suspension DRUG

Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL

Also known as: EXPAREL®

20 mg single dose cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese male or female subjects, and his/her biological parents and grandparents are of Chinese ethnicity.
• Aged ≥18 and ≤55 years of age at screening, inclusive.
• Willing and able to give written informed consent and comply with the study visit schedule, study procedures and restrictions.
• Generally, in good health with no clinically significant abnormalities as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests.
• Have a body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight ≥50 kg at screening visit and baseline visit (Day -1).

You may not qualify if:

• Female subjects who are pregnant (positive pregnancy result at screening and on Day -1), or lactating.
• Female subjects of child bearing potential and sexually active don't agree to use medically acceptable contraceptive (e.g. insertable, injectable, transdermal, hormonal contraceptive) from the date of consent given until 30 days after administration of study drug. Menopausal woman don't have her menopausal status confirmed by follicle-stimulating hormone test at screening.
• Male subjects who are sexually active don't agree to use condom plus spermicide since the dosing day till 90 days after administration of study drug.
• Male subjects don't agree not to donate sperm since the dosing day till 90 days after administration of study drug.
• Presence of any concomitant clinically significant diseases, that would interfere with the study based on the investigator's discretion.
• History of hypersensitivity or idiopathic reaction to amide-type local anesthetics.
• Has a positive urine drug screen result for drugs of abuse or a positive blood alcohol test at the Screening Visit or baseline visit (Day-1).
• Has an abnormal (clinically significant) ECG at the screening visit. Entry of any subject with an abnormal (but not clinically significant) ECG must be approved and documented by signature of the Investigator or medically qualified subinvestigator.
• Has a supine BP outside the ranges of 90 to 140 mmHg for systolic BP and 50 to 90 mmHg, inclusive, for diastolic BP, or resting pulse rate outside the range of 40 to 100 beats per minute. If any of the values are out of range, the assessment may be repeated twice for eligibility determination at the screening visit or baseline visit (Day-1).
• Positive HIV test result at screening.
• Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.
• Has an abnormal laboratory values outside the reference range that are of clinical significance which may suggest of an underlying disease such as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values, greater than 1.5 times the upper limit of normal.
• Intake prescription or over the counter products (vitamins, dietary supplements, herbal preparations, etc.) within 14 days or less than 5 half-lives (whichever is longer) prior to screening visit.
• Blood loss or donation more than 450ml within 3 months prior to dosing.
• Previous participation in an EXPAREL® study.

Sponsors & Collaborators

• Nuance Pharma (shanghai) Co., Ltd: lead

Study Sites (1)

HUK Phase 1 clinical trials center

Hong Kong, Hongkong, 999077, China

Location

Related Publications (1)

• Cheung BM, Ng PY, Liu Y, Zhou M, Yu V, Yang J, Wang NQ. Pharmacokinetics and safety of liposomal bupivacaine after local infiltration in healthy Chinese adults: a phase 1 study. BMC Anesthesiol. 2021 Jul 27;21(1):197. doi: 10.1186/s12871-021-01407-5.

  PMID: 34315419 DERIVED

Study Officials

• Bernard Cheung, Doctor

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 8, 2019
• Study Start: November 7, 2019
• Primary Completion: December 17, 2019
• Study Completion: December 26, 2019
• Last Updated: January 18, 2020

Record last verified: 2019-11

Locations

CN (1)