Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Randomized, Four-treatment, Four-sequence, Four-period, Crossover, Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: SP-103
* Drug: ZTlido


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP-103 (1 topical system)<br>One topical system applied to the skin on the back for 12 hours. | Drug: SP-103<br>* lidocaine topical system 5.4%<br>|
| Experimental: SP-103 (2 topical systems)<br>Two topical systems applied to the skin on the back for 12 hours. | Drug: SP-103<br>* lidocaine topical system 5.4%<br>|
| Experimental: SP-103 (3 topical systems)<br>Three topical systems applied to the skin on the back for 12 hours. | Drug: SP-103<br>* lidocaine topical system 5.4%<br>|
| Active Comparator: ZTlido<br>Three topical systems applied to the skin on the back for 12 hours. | Drug: ZTlido<br>* lidocaine topical system 1.8%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of lidocaine | Peak plasma concentration of lidocaine after 12 hour topical system application | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose | 
| Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time 48 hours | Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose | 
| Area under the Plasma-Concentration Time Curve (AUC) from Time 0 to Time Infinity | Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma | 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean adhesion score | 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. | 0, 3, 6, 9, 12 hours post-dose | 
| Dermal response score | 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. | 12.5 and 14 hours post-dose |