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

• Status: Completed
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scilex Pharmaceuticals, Inc.
• Treatments: Lidocaine

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