Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects
- Registration Number
- NCT04819581
- Lead Sponsor
- Scilex Pharmaceuticals, Inc.
- 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 ZTlido.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SP-103 (2 topical systems) SP-103 Two topical systems applied to the skin on the back for 12 hours. SP-103 (3 topical systems) SP-103 Three topical systems applied to the skin on the back for 12 hours. SP-103 (1 topical system) SP-103 One topical system applied to the skin on the back for 12 hours. ZTlido ZTlido Three topical systems applied to the skin on the back for 12 hours.
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) of lidocaine 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose Peak plasma concentration of lidocaine after 12 hour topical system application
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma
Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma
- Secondary Outcome Measures
Name Time Method Mean adhesion score 0, 3, 6, 9, 12 hours post-dose Adhesion to skin assessed by FDA 0-4 scoring system. The scoring for adhesion of patches is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to \< 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to \< 75% Adhered (less than half of the patch lifting off the skin), \> 0% to \< 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). The mean score is calculated as the average of scores at time 3, 6, 9, and 12 hours.
Dermal response score 12.5 and 14 hours post-dose Product tolerability is assessed by Dermal Response Score. The application site is evaluated 30 minutes and 2 hours after product removal (12.5 and 14 hours post-dose, respectively). Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test (i.e., application) site.
Trial Locations
- Locations (1)
AXIS Clinicals
🇺🇸Dilworth, Minnesota, United States