Smoking CessationPhase 1NCT01847443

Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

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 Kingdom.

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

The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers. Read more about this study

Who is it for?: Ages 18 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: 84 participants
Where: 1 siteUnited Kingdom
Study dates: May 2013to Jun 2013
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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

BMI within the range of 19 to 30 kilograms/meters^2
Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Who cannot join

Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
Treatment with known hepatic enzyme altering agents

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Celerion - BELFAST
Belfast, Northern Ireland, BT9 6AD

Other trials in United Kingdom

About this study

Official title: A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design

Conditions: Smoking Cessation
Being tested: Nicotine (2 mg), Nicotine (4 mg)
Keywords: nicotine, nicotine replacement therapy, nicotine gum
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 gum in two formulations
Nicotine (4 mg)Drug
4 mg nicotine gum in two formulations

Study groups in NCT01847443
Study group	Role	What they receive
Test nicotine gum (2 mg)	Experimental	A single dose of Nicotine Mint Gum (2 mg) to be chewed. Receives: Drug: Nicotine (2 mg)
Test nicotine gum (4 mg)	Experimental	A single dose of Nicotine Mint Gum (4 mg) to be chewed. Receives: Drug: Nicotine (4 mg)
Reference nicotine gum (2 mg)	Active comparator	A single dose of reference nicotine gum (2 mg) to be chewed. Receives: Drug: Nicotine (2 mg)
Reference nicotine gum (4 mg)	Active comparator	A single dose of reference nicotine gum (4 mg) 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 Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
Measured: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) of Nicotine 4 mg Test and Reference Product
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Measured: Blood samples to be collected from baseline to 12 hours post dose
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
Cmax for 2 mg test was compared with 2 mg reference gum
Measured: Blood samples to be collected from baseline to 12 hours post dose
Cmax of Nicotine 4 mg Test and Reference Product
Cmax for 4 mg test was compared with 4 mg reference gum
Measured: Blood samples to be collected from baseline to 12 hours post-dose

Secondary outcomes (4)

Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Measured: Blood samples to be collected from baseline to 12 hours post dose
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Measured: Blood samples to be collected from baseline to 12 hours post dose
Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Measured: Blood samples to be collected from baseline to 12 hours post dose
Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Measured: Blood samples to be collected from baseline to 12 hours post dose

Timeline

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

May 2013Jun 2013

First posted6 May 2013 (estimated)
Study startMay 2013
Primary completionJun 2013
Study completionJun 2013

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.
Publications (1)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01847443
Sponsor's protocol ID: RH01705
Status last verified: Jan 2014
First submitted: 2 May 2013
Last updated: 11 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Du D. A Single-Dose, Crossover-Design Bioequivalence Study Comparing Two Nicotine Gum Formulations in Healthy Subjects. Adv Ther. 2018 Aug;35(8):1169-1180. doi: 10.1007/s12325-018-0752-7. Epub 2018 Jul 19.
PubMed 30027479

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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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetic Study Comparing Two Nicotine Gum Formulations in a Single Dose Design
ClinicalTrials.gov ID: NCT01847443
Acronym / sponsor ID: RH01705
Conditions: Smoking Cessation
Keywords: nicotine, nicotine replacement therapy, nicotine gum
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 6 May 2013 (estimated)
Results: Posted 11 Apr 2014

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

Arm	Type	Receives
Test nicotine gum (2 mg)	Experimental	Drug: Nicotine (2 mg)A single dose of Nicotine Mint Gum (2 mg) to be chewed.
Test nicotine gum (4 mg)	Experimental	Drug: Nicotine (4 mg)A single dose of Nicotine Mint Gum (4 mg) to be chewed.
Reference nicotine gum (2 mg)	Active comparator	Drug: Nicotine (2 mg)A single dose of reference nicotine gum (2 mg) to be chewed.
Reference nicotine gum (4 mg)	Active comparator	Drug: Nicotine (4 mg)A single dose of reference nicotine gum (4 mg) to be chewed.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

BMI within the range of 19 to 30 kilograms/meters^2
Current cigarette smokers who have smoked daily for at least a year, and smoke their first cigarette within 30 minutes of waking up

Key exclusion criteria (2 listed)

Participants who have attempted to quit smoking in the last 12 months, are currently attempting to quit smoking or reduce the number of cigarettes they smoke, or are intending to quit smoking in the next 3 months, with or without use of smoking cessation aids
Treatment with known hepatic enzyme altering agents

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

Primary outcome

Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
Time frame: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
AUC(0-t) of Nicotine 4 mg Test and Reference Product
Time frame: Blood samples to be collected from baseline to 12 hours post dose
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
Time frame: Blood samples to be collected from baseline to 12 hours post dose
Cmax for 2 mg test was compared with 2 mg reference gum
Cmax of Nicotine 4 mg Test and Reference Product
Time frame: Blood samples to be collected from baseline to 12 hours post-dose
Cmax for 4 mg test was compared with 4 mg reference gum

4 secondary outcomes

Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time frame: Blood samples to be collected from baseline to 12 hours post dose
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time frame: Blood samples to be collected from baseline to 12 hours post dose
Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time frame: Blood samples to be collected from baseline to 12 hours post dose
Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
Time frame: Blood samples to be collected from baseline to 12 hours post dose

Results and safety

Results posted to the registry on 11 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum	21	21
4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum	21	20
2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum	21	21
4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum	21	21

Primary outcome: Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product

Time frame: Blood samples to be collected from baseline to 12 hours post dose. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	Test Nicotine Gum (2 mg) n = 62	Reference Nicotine Gum (2 mg) n = 62
Value	11.49 (4.224)	10.24 (3.768)

Test Nicotine Gum (2 mg) vs Reference Nicotine Gum (2 mg): Ratio of Geometric means: 1.107 (90% CI 1.070 to 1.147), ANOVA

Population analysed: Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.

Primary outcome: AUC(0-t) of Nicotine 4 mg Test and Reference Product

Time frame: Blood samples to be collected from baseline to 12 hours post dose. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	Test Nicotine Gum (4 mg) n = 73	Reference Nicotine Gum (4 mg) n = 73
Value	23.44 (7.593)	21.50 (6.874)

Test Nicotine Gum (4 mg) vs Reference Nicotine Gum (4 mg): Ratio of Geometric means: 1.098 (90% CI 1.061 to 1.137), ANOVA

Population analysed: Bioequivalence evaluable subjects' population: participants randomized to 1of 4 treatment sequences; took atleast one dose of study medication (both test and ref) in 2 mg dose and/or in 4 mg doses; did not have any AE assimilated to vomiting in first 4h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.

Primary outcome: Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product

Time frame: Blood samples to be collected from baseline to 12 hours post dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Test Nicotine Gum (2 mg) n = 62	Reference Nicotine Gum (2 mg) n = 62
Value	3.93 (1.232)	3.72 (1.289)

Test Nicotine Gum (2 mg) vs Reference Nicotine Gum (2 mg): Ratio of Geometric means: 1.044 (90% CI 1.002 to 1.089), ANOVA

Primary outcome: Cmax of Nicotine 4 mg Test and Reference Product

Time frame: Blood samples to be collected from baseline to 12 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Test Nicotine Gum (4 mg) n = 73	Reference Nicotine Gum (4 mg) n = 73
Value	7.49 (1.720)	6.98 (1.777)

Test Nicotine Gum (4 mg) vs Reference Nicotine Gum (4 mg): Ratio of Geometric means: 1.071 (90% CI 1.028 to 1.116), ANOVA

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Nicotine Gum (2 mg)	0 of 82 (0%)	11 of 82 (13.4%)	Not reported
Reference Nicotine Gum (2 mg)	0 of 77 (0%)	12 of 77 (15.6%)	Not reported
Test Nicotine Gum (4 mg)	0 of 79 (0%)	12 of 79 (15.2%)	Not reported
Reference Nicotine Gum (4 mg)	0 of 81 (0%)	11 of 81 (13.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30027479Du D. A Single-Dose, Crossover-Design Bioequivalence Study Comparing Two Nicotine Gum Formulations in Healthy Subjects. Adv Ther. 2018 Aug;35(8):1169-1180. doi: 10.1007/s12325-018-0752-7. Epub 2018 Jul 19.

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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 Kingdom.

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 2 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 11 Apr 2014. 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 Kingdom. 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 11 Apr 2014). 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 Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product (time frame: Blood samples to be collected from baseline to 12 hours post dose). The study lists 4 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 NCT01847443, which also lists 1 linked publication.

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 11 Apr 2014.