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

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ClinicalTrials.gov Identifier: NCT04158102
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Nuance Pharma (shanghai) Co., Ltd

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Bupivacaine liposome injectable suspension Phase 1

Detailed Description:
This is a phase I, open-label, single-dose in healthy subjects conducted at single center.The objectives are to evaluate the metabolic and safety profile of EXPAREL®. Each volunteer will receive one dose of the investigational drug via subcutaneous injection at multiple points during the study period. Study duration is around 54 days, including screening, confinement, ambulatory visit and a phone follow up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Open Label Study to Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 22, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 20 mg single dose cohort
Subjects would receive a 20 mg single dose of EXPAREL®
Drug: Bupivacaine liposome injectable suspension
Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL
Other Name: EXPAREL®




Primary Outcome Measures :
  1. plasma concentration [ Time Frame: up to 14 days ]
    Maximum observed plasma concentration (Cmax)

  2. Area under the plasma concentration-versus-time curve [ Time Frame: up to 14 days ]
    Area under the plasma concentration-versus-time curve from time 0 extrapolated to infinity after drug administration (AUC0-∞)


Secondary Outcome Measures :
  1. Incidence of adverse events(AEs)which are related to exparel injection [ Time Frame: up to 21 days ]
    Adverse events refer to any treatment related abnormality with clinical significance identified by means of vital signs examination, physical check-up, twelve leads electrocardiogram inspection and laboratory tests throughout the study. Adverse events reported by subjects would also be recorded in the entire trial. All these abnormal cases described above would be reported as incidence of adverse events.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Chinese male or female subjects, and his/her biological parents and grandparents are of Chinese ethnicity.
  2. Aged ≥18 and ≤55 years of age at screening, inclusive.
  3. Willing and able to give written informed consent and comply with the study visit schedule, study procedures and restrictions.
  4. Generally, in good health with no clinically significant abnormalities as determined by medical history, physical examination, 12-lead ECG and clinical laboratory tests.
  5. 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).

Exclusion Criteria:

  1. Female subjects who are pregnant (positive pregnancy result at screening and on Day -1), or lactating.
  2. 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.
  3. 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.
  4. Male subjects don't agree not to donate sperm since the dosing day till 90 days after administration of study drug.
  5. Presence of any concomitant clinically significant diseases, that would interfere with the study based on the investigator's discretion.
  6. History of hypersensitivity or idiopathic reaction to amide-type local anesthetics.
  7. 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).
  8. 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.
  9. 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).
  10. Positive HIV test result at screening.
  11. Positive testing for HBs Antigen and/or a positive Hepatitis C antibody test result at screening.
  12. 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.
  13. 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.
  14. Blood loss or donation more than 450ml within 3 months prior to dosing.
  15. Previous participation in an EXPAREL® study.
  16. Administration of an investigational drug within 30 days or 5 elimination half-lives of the investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158102


Contacts
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Contact: Anna zhou 00-86-021-32035318 anna.zhou@nuancepharma.cn

Sponsors and Collaborators
Nuance Pharma (shanghai) Co., Ltd
Investigators
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Principal Investigator: Bernard Cheung, Doctor Queen Mary Hospital, Hong Kong

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Responsible Party: Nuance Pharma (shanghai) Co., Ltd
ClinicalTrials.gov Identifier: NCT04158102     History of Changes
Other Study ID Numbers: NB-EXP-1001
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents