Smoking CessationPhase 1NCT01536704

Nicotine Lozenge Bioequivalence Study

A Phase 1 study testing Nicotine (2 mg) and Nicotine (4 mg) in people with Smoking Cessation, run by GlaxoSmithKline at 1 site in United States.

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

To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Smoking Cessation
What is being tested?: Nicotine (2 mg) and Nicotine (4 mg)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Aug 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
Body Mass Index within the range 19-27 kilograms/meters^2

Who cannot join

Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion NEBRASKA
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges

To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.

Conditions: Smoking Cessation
Being tested: Nicotine (2 mg), Nicotine (4 mg)
Keywords: nicotine lozenge, nicotine, nicotine replacement therapy
Medical subject headings: Smoking Cessation

What participants receive

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

Nicotine (2 mg)Drug
2 mg nicotine lozenge in two formulations
Nicotine (4 mg)Drug
4 mg nicotine lozenge in two formulations

Study groups in NCT01536704
Study group	Role	What they receive
Test nicotine lozenge (2 mg)	Experimental	2 mg test nicotine lozenge to be chewed. Receives: Drug: Nicotine (2 mg)
Test nicotine lozenge (4 mg)	Experimental	4 mg test nicotine lozenge to be chewed. Receives: Drug: Nicotine (4 mg)
Reference nicotine lozenge (2 mg)	Active comparator	2 mg reference nicotine lozenge to be chewed. Receives: Drug: Nicotine (2 mg)
Reference nicotine lozenge (4 mg)	Active comparator	4 mg reference nicotine lozenge to be chewed. Receives: Drug: Nicotine (4 mg)

What is being measured

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

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]
AUC(0-t) was evaluated using the trapezoid rule.
Measured: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Maximum Observed Plasma Concentration [Cmaximum (Max)]
Cmax was depicted from plasma concentration of nicotine.
Measured: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Secondary outcomes (4)

AUC [0-infinity (Inf)]
AUC (0-inf) was evaluated using the trapezoid rule.
Measured: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Time to Reach Maximum Plasma Nicotine Concentration (Tmax)
Tmax was time at which Cmax of nicotine was reached.
Measured: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Apparent Elimination Half-life of Nicotine T(1/2)
T(1/2) was calculated using plasma time-concentration values.
Measured: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Elimination Rate Constant for Plasma Nicotine: K (el)
Kel was calculated with the help of plasma time concentration values.
Measured: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Timeline

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

Jul 2011Aug 2011

First posted22 Feb 2012 (estimated)
Study startJul 2011
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Smoking CessationStudies 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: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01536704
Sponsor's protocol ID: S6491365
Status last verified: Mar 2013
First submitted: 15 Dec 2011
Last updated: 26 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Bioequivalence Study of 2 Different Doses of Mini Cherry Nicotine Lozenges
ClinicalTrials.gov ID: NCT01536704
Acronym / sponsor ID: S6491365
Conditions: Smoking Cessation
Keywords: nicotine lozenge, nicotine, nicotine replacement therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 22 Feb 2012 (estimated)
Results: Posted 26 Apr 2013

Clinical summary

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

To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Test nicotine lozenge (2 mg)	Experimental	Drug: Nicotine (2 mg)2 mg test nicotine lozenge to be chewed.
Test nicotine lozenge (4 mg)	Experimental	Drug: Nicotine (4 mg)4 mg test nicotine lozenge to be chewed.
Reference nicotine lozenge (2 mg)	Active comparator	Drug: Nicotine (2 mg)2 mg reference nicotine lozenge to be chewed.
Reference nicotine lozenge (4 mg)	Active comparator	Drug: Nicotine (4 mg)4 mg reference nicotine lozenge to be chewed.

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
Body Mass Index within the range 19-27 kilograms/meters^2

Key exclusion criteria (1 listed)

Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit

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
Nicotine (2 mg)2 mg nicotine lozenge in two formulations	Drug	Reference nicotine lozenge (2 mg), Test nicotine lozenge (2 mg)
Nicotine (4 mg)4 mg nicotine lozenge in two formulations	Drug	Reference nicotine lozenge (4 mg), Test nicotine lozenge (4 mg)

Primary outcome

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]
Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
AUC(0-t) was evaluated using the trapezoid rule.
Maximum Observed Plasma Concentration [Cmaximum (Max)]
Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Cmax was depicted from plasma concentration of nicotine.

4 secondary outcomes

AUC [0-infinity (Inf)]
Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Time to Reach Maximum Plasma Nicotine Concentration (Tmax)
Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Apparent Elimination Half-life of Nicotine T(1/2)
Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours
Elimination Rate Constant for Plasma Nicotine: K (el)
Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Results and safety

Results posted to the registry on 26 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2 Milligram (mg) Cherry Lozenge	12	12
2mg Mint Lozenge	12	12
4mg Cherry Lozenge	13	13
4mg Mint Lozenge	13	13

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]

Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours. Mean (Standard Deviation). Unit: nanogram (ng).hour (hr)/millilitre (mL)

Measure	2mg Cherry Lozenge n = 47	2mg Mint Lozenge n = 45	4mg Cherry Lozenge n = 45	4mg Mint Lozenge n = 47
Value	18.84 (7.07)	20.71 (7.42)	34.71 (14.48)	33.68 (12.17)

2mg Cherry Lozenge vs 2mg Mint Lozenge: Geometric Mean Ratio: 0.91 (90% CI 0.88 to 0.94), Wilcoxon Signed Rank Test
4mg Cherry Lozenge vs 4mg Mint Lozenge: Geometric Mean Ratio: 1.02 (90% CI 0.98 to 1.05), Wilcoxon Signed Rank test

Population analysed: Analysis was done per intention to treat (ITT) population.

Primary outcome: Maximum Observed Plasma Concentration [Cmaximum (Max)]

Time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	2mg Cherry Lozenge n = 47	2mg Mint Lozenge n = 45	4mg Cherry Lozenge n = 45	4mg Mint Lozenge n = 47
Value	5.67 (1.53)	6.35 (1.43)	9.37 (2.63)	9.72 (2.70)

2mg Cherry Lozenge vs 2mg Mint Lozenge: Geometric Mean Ratio: 0.89 (90% CI 0.85 to 0.94), Wilcoxon Signed Rank Test
4mg Cherry Lozenge vs 4mg Mint Lozenge: Geometric Mean Ratio: 0.97 (90% CI 0.93 to 1.02), Wilcoxon Signed Rank Test

Population analysed: Analysis was done per intention to treat (ITT) population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the starting time of the investigational product, and until 5 days following last administration of the investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2mg Cherry Lozenge	0 of 47 (0%)	6 of 47 (12.8%)	Not reported
2mg Mint Lozenge	0 of 46 (0%)	9 of 46 (19.6%)	Not reported
4mg Cherry Lozenge	0 of 45 (0%)	13 of 45 (28.9%)	Not reported
4mg Mint Lozenge	1 of 47 (2.1%)	15 of 47 (31.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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?

A Phase 1 study testing Nicotine (2 mg) and Nicotine (4 mg) in people with Smoking Cessation, run by GlaxoSmithKline at 1 site in United States.

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 2 inclusion and 1 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 26 Apr 2013. 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 United States. 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?

Yes. Results are posted in the registry (first posted 26 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] (time frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours). The study lists 2 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 NCT01536704.

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 26 Apr 2013.