Pharmacokinetic Study of SP-103 in Healthy Adult Human Subjects

Scilex

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ZTlido; Drug: SP-103

Study type: Interventional

Funder types: Industry

Identifiers

NCT04819581

SCI-LIDO-PK-005

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

SP-103 (1 topical system)

Experimental group

Description:

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

Treatment:

Drug: SP-103

SP-103 (2 topical systems)

Experimental group

Description:

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

Treatment:

Drug: SP-103

SP-103 (3 topical systems)

Experimental group

Description:

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

Treatment:

Drug: SP-103

ZTlido

Active Comparator group

Description:

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

Treatment:

Drug: ZTlido