Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: SP-103; Drug: ZTlido

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Dilworth, Minnesota, United States, 56529
      • Axis Clinicals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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

Collaborators and Investigators

• Sponsor: Scilex Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Peter Boldingh, PharmD, Axis Clinicals

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2019
• Primary Completion (Actual): August 27, 2019
• Study Completion (Actual): August 27, 2019

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SCI-LIDO-PK-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No