HealthyPhase 1NCT04150536

Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% Under Conditions of Heat and Exercise

A Phase 1 study testing Lidocaine topical system 1.8% in people with Healthy, run by Scilex Pharmaceuticals, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objectives of this study are to evaluate the pharmacokinetic and adhesion performance of ZTlido (lidocaine topical system) 1.8% during physical exercise, application of heat, and under normal conditions. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lidocaine topical system 1.8%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: 8 Jan 2016to 25 Jan 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Must be healthy based on by medical history, laboratory work, and physical exam
Be at least 18 years of age
If childbearing potential, use of acceptable form of birth control
In the case of females of childbearing potential, have a negative serum pregnancy test

Who cannot join

Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
History of addiction, abuse, and misuse of any drug
Use of nicotine-containing products within 30 days

About this study

Official title: An Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Cross-over, Pharmacokinetic and Adhesion Performance Study of Lidocaine Patch 36 mg/Patch (1.8%) in Fasting, Healthy, Adult, Human Subjects, With Physical Exercise, Heat and Normal Conditions.

Read the detailed description

In this open-label, three-period crossover study, 12 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have three lidocaine topical systems applied to their back for 12 hours with 7-day washout between treatments. In each treatment period, the subject will either exercise (Treatment A), apply a heating pad (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 48 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.

Conditions: Healthy
Being tested: Lidocaine topical system 1.8%

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 ZTlido, Lidocaine patch 1.8%

Study groups in NCT04150536
Study group	Role	What they receive
Lidocaine Topical System with Moderate Exercise (Treatment A)	Experimental	Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. Subjects are instructed to exercise 30 minutes on an exercise bicycle, achieving at heart rate of approximately 108 bpm. Exercise is performed after 2.5 hours, 5.5 hours, and 8.5 hours after topical system application. Receives: Drug: Lidocaine topical system 1.8%
Lidocaine Topical System with Heat Applied (Treatment B)	Experimental	Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. A heating pad is applied for 20 minutes at 2.5, 5.5, and 8.5 hours after the product is applied. Receives: Drug: Lidocaine topical system 1.8%
Lidocaine Topical System under normal conditions (Treatment C)	Experimental	Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. No heat application or exercise is performed during this period. Receives: Drug: Lidocaine topical system 1.8%

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 and 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 and 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 plasma
Measured: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose
Cumulative Adhesion Score
Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% Adhered (less than half of the patch lifting off the skin), > 0% to < 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The cumulative adhesion score is calculated as the sum of scores at each assessment time point.
Measured: 0, 0.5, 3, 6, 9, 12 hours post-dose

Secondary outcomes (1)

Dermal Response Score
Product tolerability is assessed by Dermal Response Score. The application site is evaluated 30 minutes and 2 hours after product removal (12.5 and 14 hours post-dose, respectively). Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test (i.e., application) site.
Measured: 12.5 and 14 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 201625 Jan 2016

First posted4 Nov 2019
Study start8 Jan 2016
Primary completion25 Jan 2016
Study completion25 Jan 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04150536
Sponsor's protocol ID: SCI-LIDO-HEX-001
Status last verified: May 2024
First submitted: 31 Oct 2019
Last updated: 23 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Fudin J, Wegrzyn EL, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Crossover, Pharmacokinetic and Adhesion Performance Study of a Lidocaine Topical System 1.8% During Physical Activity and Heat Treatment in Healthy Subjects. J Pain Res. 2020 Jun 10;13:1359-1367. doi: 10.2147/JPR.S238268. eCollection 2020.
PubMed 32606902

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Cross-over, Pharmacokinetic and Adhesion Performance Study of Lidocaine Patch 36 mg/Patch (1.8%) in Fasting, Healthy, Adult, Human Subjects, With Physical Exercise, Heat and Normal Conditions.
ClinicalTrials.gov ID: NCT04150536
Acronym / sponsor ID: SCI-LIDO-HEX-001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Scilex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 8 Jan 2016 (actual)
Primary completion: 25 Jan 2016 (actual)
Study completion: 25 Jan 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Lidocaine Topical System with Moderate Exercise (Treatment A)	Experimental	Drug: Lidocaine topical system 1.8%Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. Subjects are instructed to exercise 30 minutes on an exercise bicycle, achieving at heart rate of approximately 108 bpm. Exercise is performed after 2.5 hours, 5.5 hours, and 8.5 hours after topical system application.
Lidocaine Topical System with Heat Applied (Treatment B)	Experimental	Drug: Lidocaine topical system 1.8%Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. A heating pad is applied for 20 minutes at 2.5, 5.5, and 8.5 hours after the product is applied.
Lidocaine Topical System under normal conditions (Treatment C)	Experimental	Drug: Lidocaine topical system 1.8%Three lidocaine topical systems 1.8% are applied to mid-lower back for 12 hours. No heat application or exercise is performed during this period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Must be healthy based on by medical history, laboratory work, and physical exam
Be at least 18 years of age
If childbearing potential, use of acceptable form of birth control
In the case of females of childbearing potential, have a negative serum pregnancy test

Key exclusion criteria (5 listed)

Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
History of addiction, abuse, and misuse of any drug
Use of nicotine-containing products within 30 days

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: ZTlido, Lidocaine patch 1.8%	Drug	Lidocaine Topical System under normal conditions (Treatment C), Lidocaine Topical System with Heat Applied (Treatment B), Lidocaine Topical System with Moderate Exercise (Treatment A)

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 and 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 and 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 and 48 hours post-dose
Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
Cumulative Adhesion Score
Time frame: 0, 0.5, 3, 6, 9, 12 hours post-dose
Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to < 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to < 75% Adhered (less than half of the patch lifting off the skin), > 0% to < 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The cumulative adhesion score is calculated as the sum of scores at each assessment time point.

1 secondary outcome

Dermal Response Score
Time frame: 12.5 and 14 hours post-dose

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 23 May 2024.
Derived from this study: PubMed 32606902Fudin J, Wegrzyn EL, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Crossover, Pharmacokinetic and Adhesion Performance Study of a Lidocaine Topical System 1.8% During Physical Activity and Heat Treatment in Healthy Subjects. J Pain Res. 2020 Jun 10;13:1359-1367. doi: 10.2147/JPR.S238268. eCollection 2020.

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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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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.

John Peterson, PharmD, RPh principal investigator

Axis Clinicals

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lidocaine topical system 1.8% 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 5 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 23 May 2024. 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 and 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 NCT04150536, 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 23 May 2024.