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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lidocaine topical system 1.8%
Sponsored by
Scilex Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Lidocaine Topical System with Moderate Exercise (Treatment A)

    Lidocaine Topical System with Heat Applied (Treatment B)

    Lidocaine Topical System under normal conditions (Treatment C)

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Peak plasma concentration (Cmax) of lidocaine
    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
    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
    Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    October 31, 2019
    Last Updated
    November 1, 2019
    Sponsor
    Scilex Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04150536
    Brief Title
    Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% Under Conditions of Heat and Exercise
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 8, 2016 (Actual)
    Primary Completion Date
    January 25, 2016 (Actual)
    Study Completion Date
    January 25, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Scilex Pharmaceuticals, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine Topical System with Moderate Exercise (Treatment A)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Lidocaine Topical System with Heat Applied (Treatment B)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Lidocaine Topical System under normal conditions (Treatment C)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine topical system 1.8%
    Other Intervention Name(s)
    ZTlido, Lidocaine patch 1.8%
    Primary Outcome Measure Information:
    Title
    Peak plasma concentration (Cmax) of lidocaine
    Description
    Peak plasma concentration of lidocaine after application of 3 patches for 12 hours
    Time Frame
    0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose
    Title
    Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours
    Description
    Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
    Time Frame
    0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose
    Title
    Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity
    Description
    Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
    Time Frame
    0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose
    Title
    Cumulative Adhesion Score
    Description
    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.
    Time Frame
    0, 0.5, 3, 6, 9, 12 hours post-dose
    Secondary Outcome Measure Information:
    Title
    Dermal Response Score
    Description
    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.
    Time Frame
    12.5 and 14 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Peterson, PharmD, RPh
    Organizational Affiliation
    Axis Clinicals
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32606902
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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