Status:
COMPLETED
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure
Lead Sponsor:
Scilex Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 lido...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04784728
Start Date
August 21 2019
End Date
August 31 2019
Last Update
March 5 2021
Active Locations (1)
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1
AXIS Clinicals
Dilworth, Minnesota, United States, 56529