Tobacco Use DisorderPhase 1NCT02688374

A Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Healthy Adult Smokers

A Phase 1 study testing Treatment A: Nicorette 2 mg coated mint gum, Treatment B: Nicotinell 2 mg coated mint gum and Treatment C: Nicotinell 2 mg coated fruit flavor gum in people with Tobacco Use Disorder, run by GlaxoSmithKline at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Tobacco Use Disorder
What is being tested?: Treatment A: Nicorette 2 mg coated mint gum, Treatment B: Nicotinell 2 mg coated mint gum and Treatment C: Nicotinell 2 mg coated fruit flavor gum
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteChina
Study dates: 11 Mar 2016to 12 Jun 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments and the study.
Chinese male participants between 18 and 45 years of age (inclusive) in general good physical health as judged by the Investigator.
Normal vital signs as follows:
Oral body temperature between 35.0 and 37.5 ºC (95 and 99.5 F) inclusive
Supine systolic blood pressure between 90 and 140 mmHg inclusive
Supine diastolic blood pressure between 55 and 90 mmHg inclusive

Show all 10Show fewer

Pulse rate between 50 and 100 beats per minute (bpm) inclusive
History of cigarette smoking of at least 10 cigarettes per day continuously for the past 3 months prior to screening.
Body weight ≥ 50 kg, Body Mass Index (BMI) between 19 and 28 at screening.
Ability to communicate and comply with all study requirements including the study specific chewing and swallowing procedures.

Who cannot join

Use of other investigational drugs within 30 days or 10 half-lives of enrollment, whichever is longer.
History of or known hypersensitivity to the study drug or excipients.
Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.
Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance.
History of malignancy or neoplastic disease of any organ system treated or untreated, orthostatic hypotension, cardiovascular disease, stroke, TIA, fainting or blackouts, clinically significant metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders.. within the past 5 years prior to screening.
Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, autoimmune, neurological, psychiatric, other diseases or other clinically significant laboratory findings at screening.

Show all 15Show fewer

Participant has used any medication within two weeks before first scheduled study drug administration or within less than 10 times the elimination half-life of the respective drug.
Unable to comply with the chewing and/or swallowing rhythm requirements (> 5% deviation of the total counts over 30 minutes) after trying either one of the two training sessions for 3 times.
CO > 12 ppm after at least 38 hours confinement period in clinics prior to first dosing.
Participants reports consumption of any drug metabolizing enzyme inducing or inhibiting aliments, evidence of current alcohol abuse or reports consumption exceeding 35 g of pure alcohol per day.
Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis, positive results in any of the virology tests for Human immunodeficiency virus (HIV)-Ab, Hepatitis C virus (HCV)-Ab, Surface antigen of the hepatitis B virus (HBs-Ag), and Tp-Ab.
Participation in a previous clinical study with or without another investigational product and with ~470 ml blood drawn, or blood donation within the last 3 months prior to screening or previous enrollment into the current study.
Vulnerable individual
Inability to be venipuncture and/or tolerate venous access, unwilling to accept slight irritation of the throat and increased salivation due to nicotine gum administration.
Unable or unwilling to discontinue the use or consumption of cigarette smoking, any nicotine containing products, Oral, local or topical pharmaceutical agents, consumption of caffeine/theophylline - containing products, grapefruit, Seville orange, orange, lemon, lime, apple, and pineapple, performance of unaccustomed strenuous physical exercise.

Trial locations and contacts

1 site in 1 country.

China1 site

GSK Investigational Site
Beijing, 100032

Other trials in China

About this study

Official title: A Single-Dose, Open-Label, Three-way Crossover Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Chinese Male Healthy Adult Smokers

This is a randomized, open-label, single-dose, three-period, crossover, single-center comparative bioavailability (BA) study under fasting condition in Chinese healthy male adult participants with a history of cigarette smoking. The participants will be admitted to the investigational clinic at least 38 hours before dosing and will remain domiciled until the completion of all study procedures at approximately 24 hours after dosing. Three toothpastes (one is commercial non-medicated non-nicotine containing chewing gum and other two are nicotine containing gums) will be provided across the 3 treatment periods. During each of the 3 treatment periods, participants will be under supervision in a non-smoking area and will abstain from smoking.There will be a total of at least 7 days and not more than 10 days (clinical furlough period) between treatment periods. Twenty (20) blood samples will be collected for pharmacokinetic (PK) analysis at baseline and multiple time points following study drug administration. The trial duration will be approximately 49 days and up to 55 days from screening to study end including the screening period.

Conditions: Tobacco Use Disorder
Being tested: Treatment A: Nicorette 2 mg coated mint gum, Treatment B: Nicotinell 2 mg coated mint gum, Treatment C: Nicotinell 2 mg coated fruit flavor gum
Medical subject headings: Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A: Nicorette 2 mg coated mint gumOther
Participants will be administered with 2 mg coated mint gum of Nicorette
Treatment B: Nicotinell 2 mg coated mint gumOther
Participants will be administered with 2 mg coated mint gum of Nicotinell
Treatment C: Nicotinell 2 mg coated fruit flavor gumOther
Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell

Study groups in NCT02688374
Study group	Role	What they receive
Treatment A:Treatment B:Treatment C	Other	Participants will be administered with Treatment A(Nicorette 2 mg coated mint gum) followed by Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days. Receives: Other: Treatment A: Nicorette 2 mg coated mint gum; Other: Treatment B: Nicotinell 2 mg coated mint gum; Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Treatment B:Treatment C:Treatment A	Other	Participants will be administered with Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment A(Nicorette 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days. Receives: Other: Treatment A: Nicorette 2 mg coated mint gum; Other: Treatment B: Nicotinell 2 mg coated mint gum; Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Treatment C:Treatment A:Treatment B	Other	Participants will be administered with Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment A(Nicorette 2 mg coated mint gum) followed by Treatment B (Nicotinell 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days. Receives: Other: Treatment A: Nicorette 2 mg coated mint gum; Other: Treatment B: Nicotinell 2 mg coated mint gum; Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Treatment A: Treatment C:Treatment B	Other	Participants will be administered with Treatment A (Nicorette 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment B (Nicotinell 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days. Receives: Other: Treatment A: Nicorette 2 mg coated mint gum; Other: Treatment B: Nicotinell 2 mg coated mint gum; Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Treatment B:Treatment A: Treatment C	Other	Participants will be administered with Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment A (Nicorette 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days. Receives: Other: Treatment A: Nicorette 2 mg coated mint gum; Other: Treatment B: Nicotinell 2 mg coated mint gum; Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum
Treatment C:Treatment B:Treatment A	Other	Participants will be administered with Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment A (Nicorette 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days. Receives: Other: Treatment A: Nicorette 2 mg coated mint gum; Other: Treatment B: Nicotinell 2 mg coated mint gum; Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the curve from time zero to last sampling time [AUC(0-t)]
AUC(0-t) will be calculated using the trapezoidal rule. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Measured: 2 days
Area under the curve from time zero extrapolated to infinity [AUC(0-inf)]
The area under the plasma concentration versus time curve will be calculated from time 0 to infinity where AUC = AUClast + Clast/λz Clast is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Measured: 2 days
Maximum plasma concentration (Cmax)
Cmax will be obtained graphically from the plasma concentration over time profile. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Measured: 2 days
Time to reach maximum plasma concentration (Tmax)
Tmax will be obtained graphically from the plasma concentration over time profile. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Measured: 2 days
Termination rate constant (Lambda_z)
Lambda_z will be computed as the slope of the regression line of ln (C(t)) on time. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Measured: 2 days
Elimination half life (t1/2)
T1/2 will be computed as T1/2 = 0.693/ λz. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Measured: 2 days
Systemic clearance (CL/F)
CL/F will be calculated as the Dose/AUCinf, where Dose is the actual nicotine dose released. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Measured: 2 days
Apparent volume of distribution (Vd/F)
Vd/F will be determined by the following equation: Vz/F = Dose/(lambda_z · AUCinf), where Dose is the actual nicotine dose released. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 201612 Jun 2016

First posted23 Feb 2016 (estimated)
Study start11 Mar 2016
Primary completion12 Jun 2016
Study completion12 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02688374
Sponsor's protocol ID: 204979
Status last verified: Dec 2017
First submitted: 18 Feb 2016
Last updated: 19 Dec 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Tobacco Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Open-Label, Three-way Crossover Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Chinese Male Healthy Adult Smokers
ClinicalTrials.gov ID: NCT02688374
Acronym / sponsor ID: 204979
Conditions: Tobacco Use Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 11 Mar 2016 (actual)
Primary completion: 12 Jun 2016 (actual)
Study completion: 12 Jun 2016 (actual)
First posted: 23 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment A:Treatment B:Treatment C	Other	Other: Treatment A: Nicorette 2 mg coated mint gum, Other: Treatment B: Nicotinell 2 mg coated mint gum, Other: Treatment C: Nicotinell 2 mg coated fruit flavor gumParticipants will be administered with Treatment A(Nicorette 2 mg coated mint gum) followed by Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Treatment B:Treatment C:Treatment A	Other	Other: Treatment A: Nicorette 2 mg coated mint gum, Other: Treatment B: Nicotinell 2 mg coated mint gum, Other: Treatment C: Nicotinell 2 mg coated fruit flavor gumParticipants will be administered with Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment A(Nicorette 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Treatment C:Treatment A:Treatment B	Other	Other: Treatment A: Nicorette 2 mg coated mint gum, Other: Treatment B: Nicotinell 2 mg coated mint gum, Other: Treatment C: Nicotinell 2 mg coated fruit flavor gumParticipants will be administered with Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment A(Nicorette 2 mg coated mint gum) followed by Treatment B (Nicotinell 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Treatment A: Treatment C:Treatment B	Other	Other: Treatment A: Nicorette 2 mg coated mint gum, Other: Treatment B: Nicotinell 2 mg coated mint gum, Other: Treatment C: Nicotinell 2 mg coated fruit flavor gumParticipants will be administered with Treatment A (Nicorette 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment B (Nicotinell 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Treatment B:Treatment A: Treatment C	Other	Other: Treatment A: Nicorette 2 mg coated mint gum, Other: Treatment B: Nicotinell 2 mg coated mint gum, Other: Treatment C: Nicotinell 2 mg coated fruit flavor gumParticipants will be administered with Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment A (Nicorette 2 mg coated mint gum) followed by Treatment C (Nicotinell 2 mg coated fruit flavor gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.
Treatment C:Treatment B:Treatment A	Other	Other: Treatment A: Nicorette 2 mg coated mint gum, Other: Treatment B: Nicotinell 2 mg coated mint gum, Other: Treatment C: Nicotinell 2 mg coated fruit flavor gumParticipants will be administered with Treatment C (Nicotinell 2 mg coated fruit flavor gum) followed by Treatment B (Nicotinell 2 mg coated mint gum) followed by Treatment A (Nicorette 2 mg coated mint gum). Administration of each treatment will be separated by clinical furlough period of at least 7 days and not more than 10 days.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments and the study.
Chinese male participants between 18 and 45 years of age (inclusive) in general good physical health as judged by the Investigator.
Normal vital signs as follows:
Oral body temperature between 35.0 and 37.5 ºC (95 and 99.5 F) inclusive
Supine systolic blood pressure between 90 and 140 mmHg inclusive

Key exclusion criteria (15 listed)

Use of other investigational drugs within 30 days or 10 half-lives of enrollment, whichever is longer.
History of or known hypersensitivity to the study drug or excipients.
Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.
Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance.
History of malignancy or neoplastic disease of any organ system treated or untreated, orthostatic hypotension, cardiovascular disease, stroke, TIA, fainting or blackouts, clinically significant metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders.. within the past 5 years prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment A: Nicorette 2 mg coated mint gumParticipants will be administered with 2 mg coated mint gum of Nicorette	Other	Treatment A: Treatment C:Treatment B, Treatment A:Treatment B:Treatment C, Treatment B:Treatment A: Treatment C, Treatment B:Treatment C:Treatment A, Treatment C:Treatment A:Treatment B, Treatment C:Treatment B:Treatment A
Treatment B: Nicotinell 2 mg coated mint gumParticipants will be administered with 2 mg coated mint gum of Nicotinell	Other	Treatment A: Treatment C:Treatment B, Treatment A:Treatment B:Treatment C, Treatment B:Treatment A: Treatment C, Treatment B:Treatment C:Treatment A, Treatment C:Treatment A:Treatment B, Treatment C:Treatment B:Treatment A
Treatment C: Nicotinell 2 mg coated fruit flavor gumParticipants will be administered with 2 mg coated fruit flavor gum of Nicotinell	Other	Treatment A: Treatment C:Treatment B, Treatment A:Treatment B:Treatment C, Treatment B:Treatment A: Treatment C, Treatment B:Treatment C:Treatment A, Treatment C:Treatment A:Treatment B, Treatment C:Treatment B:Treatment A

Primary outcome

Area under the curve from time zero to last sampling time [AUC(0-t)]
Time frame: 2 days
AUC(0-t) will be calculated using the trapezoidal rule. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Area under the curve from time zero extrapolated to infinity [AUC(0-inf)]
Time frame: 2 days
The area under the plasma concentration versus time curve will be calculated from time 0 to infinity where AUC = AUClast + Clast/λz Clast is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Maximum plasma concentration (Cmax)
Time frame: 2 days
Cmax will be obtained graphically from the plasma concentration over time profile. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Time to reach maximum plasma concentration (Tmax)
Time frame: 2 days
Tmax will be obtained graphically from the plasma concentration over time profile. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Termination rate constant (Lambda_z)
Time frame: 2 days
Lambda_z will be computed as the slope of the regression line of ln (C(t)) on time. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Elimination half life (t1/2)
Time frame: 2 days
T1/2 will be computed as T1/2 = 0.693/ λz. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Systemic clearance (CL/F)
Time frame: 2 days
CL/F will be calculated as the Dose/AUCinf, where Dose is the actual nicotine dose released. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.
Apparent volume of distribution (Vd/F)
Time frame: 2 days
Vd/F will be determined by the following equation: Vz/F = Dose/(lambda_z · AUCinf), where Dose is the actual nicotine dose released. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve from time zero to last sampling time [AUC(0-t)] (time frame: 2 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688374.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.