Pharmacokinetics of Lidocaine in Healthy Adults

NCT03310970 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201701725
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm® topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured by Mylan Pharmaceuticals) in healthy adults, and to ensure the safety of individuals utilizing these types of products.

Conditions

Healthy

Keywords

Peer Reviewed Research

Outcome Measures

Primary Outcomes (1)

• Measurement of Maximum Serum Concentration of Lidocaine (Cmax)

  Cmax is the highest lidocaine concentration measured in the serum.

  For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.

Secondary Outcomes (5)

• Measurement of Volume of Lidocaine Distribution (V)

  For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.

• Measurement of Time of Maximum Serum Lidocaine Concentration (Tmax).

  For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.

• Measurement of Elimination Rate Constant of Lidocaine (Kel)

  For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.

• Determination of Area Under the Serum-concentration-time Curve (AUC)

  For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.

• Residual Drug Analysis in Worn TDDS and Patches

  Measured after patches are removed from subjects following 12 hours of patch wear.

Study Arms (3)

Lidocaine 5% patch

ACTIVE COMPARATOR

Each subject will wear three generic Lidocaine 5% topical patches for 12 hours.

Drug: Lidocaine 5% patch

Lidoderm® 5% patch

ACTIVE COMPARATOR

Each subject will wear three Lidoderm® topical patches for 12 hours.

Drug: Lidoderm 5% patch

Intravenous lidocaine

ACTIVE COMPARATOR

A single intravenous dose of 0.5 mg/kg lidocaine hydrochloride will be administered to each subject.

Drug: Lidocaine hydrochloride

Interventions

Lidocaine 5% patch DRUG

Each subject will wear three generic Lidocaine 5% topical patches for 12 hours.

Lidocaine 5% patch

Lidocaine hydrochloride DRUG

Each subject will receive a dose of 0.5 mg/kg intravenously over a period of 5 minutes.

Intravenous lidocaine

Lidoderm 5% patch DRUG

Each subject will wear three Lidoderm® topical patches for 12 hours.

Lidoderm® 5% patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or non-pregnant women, of any ethnic background, between the age of 18 and 65 years old.
• Provide written informed consent before initiation of any study procedures.
• Available for follow-up for the planned duration of the study.
• Able to communicate well with the investigators.
• Demonstrate comprehension of the protocol procedures and knowledge of study, as demonstrated by a study member filling out a consent checklist form to verify that the subject understands all aspects of the study including the purpose, procedures, risks and benefits.
• Able to adhere to the study protocol schedule, study restrictions and examination schedule.
• Subjects must be non-smokers and not regular users of tobacco. They must have refrained from regular and habitual use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 12 months and must have not used any nicotine-containing products in the previous 30 days.
• Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).
• Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI), as determined by medical history, physical examination, and medication history.
• Negative urine drug screening test.
• Have a normal blood pressure (systolic: 90-139 mmHg; diastolic: 60-89 mmHg) and heart rate (55-100 bpm).
• Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST.
• Female subjects must be of non-childbearing potential. This is defined as surgically sterile (i.e. history of hysterectomy or tubal ligation), or postmenopausal for more than 1 year (no bleeding for 12 consecutive months). If the person is of childbearing potential they must be non-pregnant at the time of enrollment and on the morning of the first day of each study treatment procedure day (a urine pregnancy test will be administered if it has been \>30 days since serum pregnancy test for enrollment). The person must also agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
• Agrees not to participate in another clinical study during the study period unless the study is in the follow-up phase and it has been one month since the subject received any experimental agents or treatments. The subject also agrees not to participate in an investigational drug study for at least 30 days after last procedure day.
• Agrees not to donate blood to a blood bank throughout participation in the study and for at least 60 days after last procedure day.

You may not qualify if:

• Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test at any time during the study.
• Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow-up phase and it has been ≥ one month since the subject received any experimental agents or treatments.
• Abnormal vital signs, defined as:
• Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) at rest on two separate days.
• Heart rate \<55 at rest on two separate days
• Respiratory rate ≤ 11 to ≥ 18 breaths per minute
• Temperature \>38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within seven days of administration of a study product.
• History of chronic obstructive pulmonary disease.
• Positive urine drug screening test.
• Use of any prescription medication during the period 0 to 30 days or over-the counter medication during the period 0 to 3 days before entry to the study (vitamins, herbal supplements and birth control medications will be allowed).
• Use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product. This includes antihistamines (within 72 hours prior to dosing), systemic or topical corticosteroids within four weeks prior to dosing, use of monoamine oxidase inhibitors 21 days prior to study, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin \[BCG\], monoclonal antibodies, or radiation therapy.
• Donation or loss of greater than one pint of blood within 60 days of entry to the study.
• Any prior serious adverse reaction or hypersensitivity to lidocaine administered by any route.
• Current diagnosis of any major psychiatric illness.
• Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days before enrollment in this study or expects to receive an experimental agent during the study.

Sponsors & Collaborators

• Nicole K Brogden: lead
• Long Island University: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Lidocaine; Transdermal Patch; Lidoderm

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies

Results Point of Contact

• Title: Nicole Brogden, Associate Professor
• Organization: University of Iowa

nicole-brogden@uiowa.ed

319-335-8752

Study Officials

• Nicole K Brogden, PharmD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 16, 2017
• Study Start: March 14, 2018
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: November 1, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)