HealthyPhase 1NCT04149938
Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
A Phase 1 study testing Lidocaine topical system 1.8% and Lidocaine patch 5% in people with Healthy, run by Scilex Pharmaceuticals, Inc..
Trial summary
The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lidocaine topical system 1.8% and Lidocaine patch 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2016to 27 Oct 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be healthy based on medical history, laboratory work, and physical exam
- Be ≥18 and ≤65 years of age
- Females of childbearing potential must not be pregnant and be using an acceptable form of birth control
- Must be free of any systemic or dermatologic disorder
Who cannot join
- Use of prescription medication within 14 days or over-the-counter products within 7 days prior to study medication
- Current use of opioids
- Known hypersensitivity or allergy to any of the components of the product formulations
- Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization
About this study
Official title: Phase 1, Randomized Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).
- Conditions
- Healthy
- Being tested
- Lidocaine topical system 1.8%, Lidocaine patch 5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine topical system 1.8%Drug
Also called Lidocaine patch 1.8%, ZTlido
Lidocaine patch 5%Drug
Also called Lidoderm
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Patch (Sequence AB) | Experimental | Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. Receives: Drug: Lidocaine topical system 1.8%; Drug: Lidocaine patch 5% |
| Lidocaine Patch (Sequence BA) | Experimental | Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. Receives: Drug: Lidocaine topical system 1.8%; Drug: Lidocaine patch 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of lidocaine
Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
Measured: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours
Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
Measured: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plamsa
Measured: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Apparent dose
Apparent dose of delivered lidocaine assessed by calculating the quantity of lidocaine in the patch as manufactured minus the quantity recovered from the used patch after 12 hours of wear and adhesive residue remaining on skin and on the product liner and envelope
Measured: 0 to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start28 Sep 2016
- Primary completion27 Oct 2016
- Study completion27 Oct 2016
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 HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scilex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip LaStella, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149938
- Sponsor's protocol ID
- SCI-LIDO-PK-002A
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gudin J, Argoff C, Fudin J, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects. J Pain Res. 2020 Jun 22;13:1485-1496. doi: 10.2147/JPR.S237934. eCollection 2020.
PubMed 32606914
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04149938
- Acronym / sponsor ID
- SCI-LIDO-PK-002A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Scilex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 27 Oct 2016 (actual)
- Study completion
- 27 Oct 2016 (actual)
- First posted
- 4 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.
The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Patch (Sequence AB) | Experimental | Drug: Lidocaine topical system 1.8%, Drug: Lidocaine patch 5%Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. |
| Lidocaine Patch (Sequence BA) | Experimental | Drug: Lidocaine topical system 1.8%, Drug: Lidocaine patch 5%Subjects received all study treatments: ZTlido and Lidoderm. On Day 1 (Period 1), three Lidoderm lidocaine patches were applied to the skin on the back for 12 hours. On Day 8 (Period 2), three ZTlido lidocaine topical systems were applied to the skin on the back for 12 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be healthy based on medical history, laboratory work, and physical exam
- Be ≥18 and ≤65 years of age
- Females of childbearing potential must not be pregnant and be using an acceptable form of birth control
- Must be free of any systemic or dermatologic disorder
Key exclusion criteria (4 listed)
- Use of prescription medication within 14 days or over-the-counter products within 7 days prior to study medication
- Current use of opioids
- Known hypersensitivity or allergy to any of the components of the product formulations
- Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization
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 |
|---|---|---|
| Lidocaine topical system 1.8%Also: Lidocaine patch 1.8%, ZTlido | Drug | Lidocaine Patch (Sequence AB), Lidocaine Patch (Sequence BA) |
| Lidocaine patch 5%Also: Lidoderm | Drug | Lidocaine Patch (Sequence AB), Lidocaine Patch (Sequence BA) |
Primary outcome
Peak plasma concentration (Cmax) of lidocaine
Time frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours
Time frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity
Time frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plamsa
Apparent dose
Time frame: 0 to 12 hours
Apparent dose of delivered lidocaine assessed by calculating the quantity of lidocaine in the patch as manufactured minus the quantity recovered from the used patch after 12 hours of wear and adhesive residue remaining on skin and on the product liner and envelope
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 4 Nov 2019.
- Derived from this study: PubMed 32606914Gudin J, Argoff C, Fudin J, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects. J Pain Res. 2020 Jun 22;13:1485-1496. doi: 10.2147/JPR.S237934. eCollection 2020.
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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.
Phillip LaStella, MD principal investigator
TKL Research, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lidocaine topical system 1.8% and Lidocaine patch 5% in people with Healthy, run by Scilex Pharmaceuticals, Inc..
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 4 inclusion and 4 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Peak plasma concentration (Cmax) of lidocaine (time frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose). The study lists 4 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 NCT04149938, 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 4 Nov 2019.