- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04150536
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% Under Conditions of Heat and Exercise
November 1, 2019 updated by: Scilex Pharmaceuticals, Inc.
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.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lidocaine Topical System with Moderate Exercise (Treatment A)
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.
|
Other Names:
|
Experimental: Lidocaine Topical System with Heat Applied (Treatment B)
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.
|
Other Names:
|
Experimental: Lidocaine Topical System under normal conditions (Treatment C)
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.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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
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
|
0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose
|
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.
|
0, 0.5, 3, 6, 9, 12 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dermal Response Score
Time Frame: 12.5 and 14 hours post-dose
|
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.
|
12.5 and 14 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Peterson, PharmD, RPh, AXIS Clinicals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2016
Primary Completion (Actual)
January 25, 2016
Study Completion (Actual)
January 25, 2016
Study Registration Dates
First Submitted
October 31, 2019
First Submitted That Met QC Criteria
November 1, 2019
First Posted (Actual)
November 4, 2019
Study Record Updates
Last Update Posted (Actual)
November 4, 2019
Last Update Submitted That Met QC Criteria
November 1, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Cicatrix
- Tissue Adhesions
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- SCI-LIDO-HEX-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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