Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

Phase 1CompletedNCT04819581

Scilex Pharmaceuticals, Inc.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

SP-103DRUG

lidocaine topical system 5.4%

ZTlidoDRUG

lidocaine topical system 1.8%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

AXIS Clinicals

Dilworth, Minnesota, United States

Outcomes

Primary Outcomes

Peak plasma concentration (Cmax) of lidocaine

Peak plasma concentration of lidocaine after 12 hour topical system application

Time frame: 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

Time frame: 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

Time frame: 0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.