Clinical trial NCT04784728: Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure
Official title: A Phase 1, Open Label, Randomized, Three-treatment, Three-sequence, Three-period, Crossover Adhesion Performance and Pharmacokinetic Study of Lidocaine Topical System 1.8% in Healthy, Adult Subjects Under Normal and Two Water Stress Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Key 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

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)
* 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

Primary outcomes:
measure: Mean cumulative adhesion score
timeFrame: Over 12 hours
Secondary outcomes:
measure: Peak plasma concentration (Cmax) of lidocaine
timeFrame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
measure: Area under the plasma concentration-time curve (AUC) from Time 0 to Time 24 hours
timeFrame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
measure: Area under the plasma concentration-time curve (AUC) from Time 0 to Time Infinity
timeFrame: 0, 1.5, 3.0, 6.0, 9.0, 12.0, 15.0, 18.0, 24.0 hours post-dose
measure: Dermal Response Score
timeFrame: 12.5 and 14 hours post-dose
Other outcomes:
Locations:
city: Dilworth
country: United States
facility: AXIS Clinicals
state: Minnesota
Study officials:
affiliation: AXIS Clinicals
name: Peter Boldingh, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.