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

NCT05024747 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 217756
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Nicotine Concentration (Cmax) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)

  Cmax was the highest observed plasma nicotine concentration of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was reported. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed pharmacokinetic (PK) variables, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.

  Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dose in each treatment period

• Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t]) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)

  Area under the plasma concentration versus time curve from time zero to time t, where t was the time of the last measurable plasma concentration of nicotine, estimated, computed using the linear trapezoidal rule. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed PK variable, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.

  Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dose

• Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity (AUC [(0-inf]) of NicoDerm CQ Dungarvan (Test) Compared to NicoDerm CQ, Alza (Reference)

  Area under the plasma concentration versus time curve calculated from time zero to infinity. AUC0-inf = AUC0-t + C(t)/λz. C(t)- Concentration at the last measurable sampling time point and λz- terminal elimination rate constant. Blood samples were collected at indicated time points. Pharmacokinetic analysis of NicoDerm CQ Dungarvan (Test) compared to NicoDerm CQ, Alza (Reference) was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed effects model fit to the log-transformed PK variable, as the dependent variable, treatment, and period as fixed effects. Geometric mean and CV of the geometric mean was presented. Comparison data of Test vs Reference was reported based on the baseline adjusted data.in statistical analysis 1.

  Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dose

Secondary Outcomes (5)

• Terminal Elimination Rate Constant (Lambda z) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) of Patches

  Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dose

• Maximum Plasma Nicotine Concentration (Tmax) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches

  Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dose

• Elimination Half-Life (t1/2) of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches

  Pre-dose (within 1 hour before dosing), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 25, 26, 27, 28, 30, 32, and 36 hours post-dose

• Number of Participants With Adhesion Score of NicoDerm CQ Dungarvan (Test) and NicoDerm CQ, Alza (Reference) Patches

  At 0, 6, 12, 18 and 24 hours post-dose

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (TEAEs)

  From start of study drug administration up to end of study visit (up to Day 6)

Study Arms (2)

Test Product

EXPERIMENTAL

Participants will receive a single NicoDerm CQ patch (GSK Dungarvan) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours.

Drug: NicoDerm CQ patch (GSK Dungarvan)

Reference Product

ACTIVE COMPARATOR

Participants will receive a single NicoDerm CQ patch (Alza) placed topically under fasted conditions to the upper part of the back for a total duration of 24 hours.

Drug: NicoDerm CQ (Alza)

Interventions

NicoDerm CQ patch (GSK Dungarvan) DRUG

A single patch of a NicoDerm CQ (GSK Dungarvan) 21 mg per system of 22 centimeter square (cm\^2) surface area will be placed topically.

Test Product

NicoDerm CQ (Alza) DRUG

A single patch of a NicoDerm CQ (Alza) 21 mg/system of 22 cm\^2 surface area will be placed topically.

Reference Product

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

GSK Investigational Site

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+44 7880 182593

Study Officials

• GSK ClinicalTrials

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: September 1, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: March 21, 2024
• Results First Posted: March 21, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (1)