Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04819581
• Other study ID #: SCI-LIDO-PK-005
• Status: Completed
• Phase: Phase 1
• Start date: August 3, 2019
• Est. completion date: August 27, 2019

Study information

• Verified date: March 2021
• Source: Scilex Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 27, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SP-103
lidocaine topical system 5.4%
• ZTlido
lidocaine topical system 1.8%

Locations

Country	Name	City	State
United States	AXIS Clinicals	Dilworth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Scilex Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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