CompletedPhase 1

Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% Under Conditions of Heat and Exercise

12 participantsStarted 2016-01-08

Plain-language summary

The objectives of this study are to evaluate the pharmacokinetic and adhesion performance of ZTlido (lidocaine topical system) 1.8% during physical exercise, application of heat, and under normal conditions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Must be healthy based on by medical history, laboratory work, and physical exam * Be at least 18 years of age * 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) * History of addiction, abuse, and misuse of any drug * Use of nicotine-containing products within 30 days

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peak plasma concentration (Cmax) of lidocaine

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

Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours

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

Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity

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

Cumulative Adhesion Score

Timeframe: 0, 0.5, 3, 6, 9, 12 hours post-dose

Trial details

NCT IDNCT04150536

SponsorScilex Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01-25

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Peak plasma concentration (Cmax) of lidocaine

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

Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours

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

Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity

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

Cumulative Adhesion Score

Timeframe: 0, 0.5, 3, 6, 9, 12 hours post-dose