A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers

Completed · Phase 1

Conditions studied: Tobacco Use Disorder

In brief

The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently manufactured by Alza (Reference).

Key facts

Study ID

NCT05024747

Run by

HALEON

People needed

22

Starts

2021-09-01

Expected to finish

2021-10-25

Last updated by the study team

2024-03-21

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
• Participant is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, as determined by medical evaluation, including a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) or clinical laboratory tests.
• Body Mass Index (BMI) of 19 to 27 kilogram/meter Squared (kg/m\^2); and a total body weight >50 kg (110 Pound-Mass [lbs]).
• Any female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment. Female participant who are not of childbearing potential must meet requirements of protocol.
• Participants admits to having smoked more than 10 cigarettes per day for the preceding one year (prior to initial dose).
• Participant with two negative tests (one at screening and one at check in Day-2) for active COVID-19, separated by > 24 hours.

You may not qualify if…

• A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK Consumer Health (CH) employee directly involved in the conduct of the study or a member of their immediate family.
• A participant who has participated in other studies (including non-medicinal studies) involving any investigational product(s) within 30 days before first dosing.
• A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• A Participant who is pregnant as confirmed by a positive serum pregnancy test or intending to become pregnant over the duration of the study.
• A participant who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients ethylene vinyl acetatecopolymer, polyisobutylene and high density polyethylene.
• Diagnosis of long QT syndrome or corrected QT (QTc) > 450 Millisecond (msec) for a male participant and > 470 msec for a female participant at screening.
• A participant unwilling or unable to comply with Lifestyle Considerations described in this protocol.
• Participant is unwilling to abstain from tobacco or nicotine-containing product use during the study (from check-in to the completion of the last pharmacokinetics (PK) blood sampling). Expired carbon monoxide (CO) measurement immediately prior to randomization (first treatment session) and dosing (second treatment session) should be less than or equal to (<=) 10 parts per million (ppm) for the participant to be dosed.
• Participant has used chewing tobacco, tobacco products or electronic cigarettes other than cigarettes within 21 days of Visit 1.
• Use of any medication (including over-the-counter medications and herbal remedies) within 2 weeks before first scheduled study drug administration or within < 10 times the elimination half-life of the respective drug (whichever is longer), or is anticipated to require any concomitant medication during that period or at any time throughout the study. Allowed treatments are:
• systemic contraceptives and hormone replacement therapy, as long as female participant is on stable treatment for at least 3 months and continues treatment throughout the study.
• Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation, as assessed by the Investigator or medically qualified designee.
• A participant with a positive urine drug screen, for Tetrahydrocannabinol (THC), amphetamine, cocaine, 3,4-methylenedioxy-N-methylamphetamine (MDMA)/ecstasy, methamphetamine, or opiates.
• Clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study.
• participant with signs and symptoms suggestive of COVID-19 (i.e. fever, cough, etc) within 14 days of inpatient admission.
• Participant with known COVID-19 positive contacts in the past 14 days.
• Presence of tattoo, excessive hair (including shaved hair) or scarring on the test site on the back which in the opinion of the investigator would interfere with the study assessments.
• Participant who currently in the opinion of the investigator, after medical review, has any of the following conditions:
• Thrombophlebitis, thromboembolic disorders
• A history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebrovascular or coronary artery disease (current or history)
• Valvular heart disease with complications
• Severe hypertension
• Diabetes with vascular involvement

Where it is running

• GSK Investigational Site — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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