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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784728
• Other study ID #: SCI-LIDO-ADH-004
• Status: Completed
• Phase: Phase 1
• Start date: August 21, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2021
• Source: Scilex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Tissue Adhesions

Intervention

Drug:
• Lidocaine topical system 1.8%
lidocaine patch

Locations

Country	Name	City	State
United States	AXIS Clinicals	Dilworth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Scilex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Over 12 hours
Secondary	Peak plasma concentration (Cmax) of lidocaine	Peak plasma concentration of lidocaine after product application for 12 hours	0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Secondary	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	0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Secondary	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	0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
Secondary	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.	12.5 and 14 hours post-dose