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

NCT ID: NCT04150536

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-08
• Study Completion Date: 2016-01-25

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.

Detailed 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.

Conditions

Healthy

Study Design

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

Study Groups

Lidocaine Topical System with Moderate Exercise (Treatment A)

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.

Group Type: EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type: DRUG

Lidocaine Topical System with Heat Applied (Treatment B)

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.

Group Type: EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type: DRUG

Lidocaine Topical System under normal conditions (Treatment C)

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.

Group Type: EXPERIMENTAL

Lidocaine topical system 1.8%

Intervention Type: DRUG

Interventions

Lidocaine topical system 1.8%

Intervention Type: DRUG

Other Intervention Names

ZTlido; Lidocaine patch 1.8%

Eligibility Criteria

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

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

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

Sponsors

Scilex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Peterson, PharmD, RPh

Role: PRINCIPAL_INVESTIGATOR

Axis Clinicals

References

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.

Reference Type: DERIVED

PMID: 32606902 (View on PubMed)

Other Identifiers

SCI-LIDO-HEX-001

Identifier Type: -

Identifier Source: org_study_id