NCT04784728

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Scilex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Lidocaine topical system 1.8%	lidocaine patch

Timeline

• Start date: 2019-08-21
• Primary completion: 2019-08-31
• Completion: 2019-08-31
• First posted: 2021-03-05
• Last updated: 2021-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study