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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150536
• Other study ID #: SCI-LIDO-HEX-001
• Status: Completed
• Phase: Phase 1
• Start date: January 8, 2016
• Est. completion date: January 25, 2016

Study information

• Verified date: May 2024
• 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 pharmacokinetic and adhesion performance of ZTlido (lidocaine topical system) 1.8% during physical exercise, application of heat, and under normal conditions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 25, 2016
• Est. primary completion date: January 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Tissue Adhesions

Intervention

Drug:
• Lidocaine topical system 1.8%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scilex Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak plasma concentration (Cmax) of lidocaine	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
Primary	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	0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose
Primary	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, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22 24 and 48 hours post-dose
Primary	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.	0, 0.5, 3, 6, 9, 12 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