Status:
COMPLETED
Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
Lead Sponsor:
Scilex Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will assess the systemic exposure and pharmacokinetic parameters of SP-103 topical system following one, two, or three topical system applications and compare to the pharmacokinetics of ZTl...
Eligibility Criteria
Inclusion
- Key
- Must be healthy based on by medical history, laboratory work, ECG, and physical exam
- Body mass index ranging between 18.0-32.5 kg/m2, inclusive
- If childbearing potential, use of acceptable form of birth control
- In the case of females of childbearing potential, have a negative serum pregnancy test
- 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 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04819581
Start Date
August 3 2019
End Date
August 27 2019
Last Update
March 29 2021
Active Locations (1)
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1
AXIS Clinicals
Dilworth, Minnesota, United States, 56529