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Completed

NCT Number: NCT04150536

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine topical system 1.8%

Drug

Other names: ZTlido, Lidocaine patch 1.8%

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Scilex Pharmaceuticals, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 4, 2019
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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