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

NCT04150536 | Completed Phase 1 FDA Drug

• 1 other identifier: SCI-LIDO-HEX-001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Dermal Response Score

  12.5 and 14 hours post-dose

Study Arms (3)

Lidocaine Topical System with Moderate Exercise (Treatment A)

EXPERIMENTAL

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.

Drug: Lidocaine topical system 1.8%

Lidocaine Topical System with Heat Applied (Treatment B)

EXPERIMENTAL

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.

Drug: Lidocaine topical system 1.8%

Lidocaine Topical System under normal conditions (Treatment C)

EXPERIMENTAL

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.

Drug: Lidocaine topical system 1.8%

Interventions

Lidocaine topical system 1.8% DRUG

Also known as: ZTlido, Lidocaine patch 1.8%

Lidocaine Topical System under normal conditions (Treatment C); Lidocaine Topical System with Heat Applied (Treatment B); Lidocaine Topical System with Moderate Exercise (Treatment A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Related Publications (1)

• 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.

  PMID: 32606902 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• John Peterson, PharmD, RPh

  Axis Clinicals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: January 8, 2016
• Primary Completion: January 25, 2016
• Study Completion: January 25, 2016
• Last Updated: May 23, 2024

Record last verified: 2024-05