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

NCT ID: NCT04784728

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-21
• Study Completion Date: 2019-08-31

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.

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lidocaine topical system with swimming (Treatment A)

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.

Group Type: EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type: DRUG

lidocaine patch

Lidocaine topical system with showering (Treatment B)

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.

Group Type: EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type: DRUG

lidocaine patch

Lidocaine topical system under normal conditions (Treatment C)

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

Group Type: EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type: DRUG

lidocaine patch

Interventions

Lidocaine topical system 1.8%

lidocaine patch

Intervention Type: DRUG

Other Intervention Names

ZTlido

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scilex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Boldingh, PharmD

Role: PRINCIPAL_INVESTIGATOR

AXIS Clinicals

Locations

AXIS Clinicals

Dilworth, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34429646 (View on PubMed)

Other Identifiers

SCI-LIDO-ADH-004

Identifier Type: -

Identifier Source: org_study_id