Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

NCT04819581 | Completed Phase 1 FDA Drug

• 1 other identifier: SCI-LIDO-PK-005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Mean adhesion score

  0, 3, 6, 9, 12 hours post-dose

• Dermal response score

  12.5 and 14 hours post-dose

Study Arms (4)

SP-103 (1 topical system)

EXPERIMENTAL

One topical system applied to the skin on the back for 12 hours.

Drug: SP-103

SP-103 (2 topical systems)

EXPERIMENTAL

Two topical systems applied to the skin on the back for 12 hours.

Drug: SP-103

SP-103 (3 topical systems)

EXPERIMENTAL

Three topical systems applied to the skin on the back for 12 hours.

Drug: SP-103

ZTlido

ACTIVE COMPARATOR

Three topical systems applied to the skin on the back for 12 hours.

Drug: ZTlido

Interventions

SP-103 DRUG

lidocaine topical system 5.4%

SP-103 (1 topical system); SP-103 (2 topical systems); SP-103 (3 topical systems)

ZTlido DRUG

lidocaine topical system 1.8%

ZTlido

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Study Sites (1)

AXIS Clinicals

Dilworth, Minnesota, 56529, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Peter Boldingh, PharmD

  AXIS Clinicals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 29, 2021
• Study Start: August 3, 2019
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)