Healthy SubjectsPhase 1NCT04158102
Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects
A Phase 1 study testing Bupivacaine liposome injectable suspension in people with Healthy Subjects, run by Nuance Pharma (shanghai) Co., Ltd at 1 site in China.
Trial summary
This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Bupivacaine liposome injectable suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2019to 26 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label Study to Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects
This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- Bupivacaine liposome injectable suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine liposome injectable suspensionDrug
Also called EXPAREL®
Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL
| Study group | Role | What they receive |
|---|---|---|
| 20 mg single dose cohort | Experimental | Subjects would receive a 20 mg single dose of EXPAREL® Receives: Drug: Bupivacaine liposome injectable suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentration
Maximum observed plasma concentration (Cmax)
Measured: 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-∞)
Measured: up to 14 days
Secondary outcomes (1)
Incidence of adverse events（AEs）which are related to exparel injection
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.
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start7 Nov 2019
- Primary completion17 Dec 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuance Pharma (shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard Cheung, Doctor, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158102
- Sponsor's protocol ID
- NB-EXP-1001
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34315419
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label Study to Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04158102
- Acronym / sponsor ID
- NB-EXP-1001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nuance Pharma (shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 mg single dose cohort | Experimental | Drug: Bupivacaine liposome injectable suspensionSubjects would receive a 20 mg single dose of EXPAREL® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine liposome injectable suspensionAlso: EXPAREL®Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL | Drug | 20 mg single dose cohort |
Primary outcome
plasma concentration
Time frame: up to 14 days
Maximum observed plasma concentration (Cmax)
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-∞)
1 secondary outcome
Incidence of adverse events（AEs）which are related to exparel injection
Time frame: up to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 34315419Cheung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Cheung, Doctor principal investigator
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine liposome injectable suspension in people with Healthy Subjects, run by Nuance Pharma (shanghai) Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentration (time frame: up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04158102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.