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

NCT04784728 | Completed Phase 1 FDA Drug

• 1 other identifier: SCI-LIDO-ADH-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Peak plasma concentration (Cmax) of lidocaine

  0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose

• Area under the plasma concentration-time curve (AUC) from Time 0 to Time 24 hours

  0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose

• Area under the plasma concentration-time curve (AUC) from Time 0 to Time Infinity

  0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose

• Dermal Response Score

  12.5 and 14 hours post-dose

Study Arms (3)

Lidocaine topical system with swimming (Treatment A)

EXPERIMENTAL

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.

Drug: Lidocaine topical system 1.8%

Lidocaine topical system with showering (Treatment B)

EXPERIMENTAL

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.

Drug: Lidocaine topical system 1.8%

Lidocaine topical system under normal conditions (Treatment C)

EXPERIMENTAL

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

Drug: Lidocaine topical system 1.8%

Interventions

Lidocaine topical system 1.8% DRUG

lidocaine patch

Also known as: ZTlido

Lidocaine topical system under normal conditions (Treatment C); Lidocaine topical system with showering (Treatment B); Lidocaine topical system with swimming (Treatment A)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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)
• 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

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Study Sites (1)

AXIS Clinicals

Dilworth, Minnesota, 56529, United States

Location

Related Publications (1)

• 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.

  PMID: 34429646 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Peter Boldingh, PharmD

  AXIS Clinicals

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: August 21, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

US (1)