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Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
United States
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 treatment trial for Healthy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  • Must be healthy based on medical history, laboratory work, and physical exam
  • Body mass index ranging between 18.0-30.0 kg/m2, inclusive
  • Capable of unaided swimming
  • If childbearing potential, use of acceptable form of birth control
  • In case of females of childbearing potential, have a negative serum pregnancy

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)
  • Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
  • History of addiction, abuse, or misuse of any drug
  • Use of nicotine-containing products within 30 days

Sites / Locations

  • AXIS Clinicals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lidocaine topical system with swimming (Treatment A)

Lidocaine topical system with showering (Treatment B)

Lidocaine topical system under normal conditions (Treatment C)

Arm Description

One topical system is applied to the mid- to upper-back for 12 hours. Subjects swim for 15 minutes in a heated pool 4 hours after topical system application.

One topical system is applied to the mid- to upper-back for 12 hours. Subjects take a 10-minute shower 8 hours after topical system application.

One topical system is applied to the mid- to upper-back for 12 hours. Topical systems are not exposed to water during this period.

Outcomes

Primary Outcome Measures

Mean 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 (3, 4.5, 7, 8.5, and 12 hours).

Secondary Outcome Measures

Peak plasma concentration (Cmax) of lidocaine
Peak plasma concentration of lidocaine after product application for 12 hours
Area under the plasma concentration-time curve (AUC) from Time 0 to Time 24 hours
Area under the plasma concentration versus time curve from 0 to 24 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
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
March 3, 2021
Last Updated
March 4, 2021
Sponsor
Scilex Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04784728
Brief Title
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure
Official Title
A Phase 1, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (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 adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.
Detailed Description
In this Phase 1, open-label, three-period crossover study, 24 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments. In each treatment period, the subject will either swim (Treatment A), shower (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 24 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
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine topical system with swimming (Treatment A)
Arm Type
Experimental
Arm Description
One topical system is applied to the mid- to upper-back for 12 hours. Subjects swim for 15 minutes in a heated pool 4 hours after topical system application.
Arm Title
Lidocaine topical system with showering (Treatment B)
Arm Type
Experimental
Arm Description
One topical system is applied to the mid- to upper-back for 12 hours. Subjects take a 10-minute shower 8 hours after topical system application.
Arm Title
Lidocaine topical system under normal conditions (Treatment C)
Arm Type
Experimental
Arm Description
One topical system is applied to the mid- to upper-back for 12 hours. Topical systems are not exposed to water during this period.
Intervention Type
Drug
Intervention Name(s)
Lidocaine topical system 1.8%
Other Intervention Name(s)
ZTlido
Intervention Description
lidocaine patch
Primary Outcome Measure Information:
Title
Mean 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 (3, 4.5, 7, 8.5, and 12 hours).
Time Frame
Over 12 hours
Secondary Outcome Measure Information:
Title
Peak plasma concentration (Cmax) of lidocaine
Description
Peak plasma concentration of lidocaine after product application for 12 hours
Time Frame
0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Title
Area under the plasma concentration-time curve (AUC) from Time 0 to Time 24 hours
Description
Area under the plasma concentration versus time curve from 0 to 24 hours of lidocaine in plasma
Time Frame
0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 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, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
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
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Must be healthy based on medical history, laboratory work, and physical exam Body mass index ranging between 18.0-30.0 kg/m2, inclusive Capable of unaided swimming If childbearing potential, use of acceptable form of birth control In case of females of childbearing potential, have a negative serum pregnancy 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) Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application. History of addiction, abuse, or misuse of any drug Use of nicotine-containing products within 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Boldingh, PharmD
Organizational Affiliation
AXIS Clinicals
Official's Role
Principal Investigator
Facility Information:
Facility Name
AXIS Clinicals
City
Dilworth
State/Province
Minnesota
ZIP/Postal Code
56529
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34429646
Citation
Vought K, Greuber E, Patel K, Argoff C, Lissin D. A Randomized, Crossover, Adhesion Performance and Pharmacokinetic Study of a Lidocaine Topical System Under Conditions of Water Exposure in Healthy Subjects. J Pain Res. 2021 Aug 16;14:2459-2467. doi: 10.2147/JPR.S323789. eCollection 2021.
Results Reference
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Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure

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