Smoking CessationPhase 2NCT01669122

Pharmacokinetic Study of 4 mg Nicotine Lozenge.

A Phase 2 study testing nicotine in people with Smoking Cessation, run by GlaxoSmithKline at 1 site in India.

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 yearsHealthy volunteers can take part
Conditions the study is for: Smoking Cessation
What is being tested?: nicotine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteIndia
Study dates: Jun 2012to Aug 2012
Phase: Phase 2
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.

Who cannot join

inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing

Trial locations and contacts

1 site in 1 country.

India1 site

Lambda Therapeutic Research Ltd
Ahmedabad, Gujarat, 380 061

Other trials in India

About this study

Official title: A Randomized, Cross-Over, Single Dose Pharmacokinetic Study of 4mg Nicotine Lozenges.

This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.

Conditions: Smoking Cessation
Being tested: nicotine
Medical subject headings: Smoking Cessation

What participants receive

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

nicotineDrug
4 mg nicotine lozenge experimental

Study groups in NCT01669122
Study group	Role	What they receive
Prototype 1	Experimental	4mg nicotine lozenge administered orally as a single dose treatment per subject Receives: Drug: nicotine
Prototype 2	Experimental	4mg nicotine lozenge administered orally as a single dose treatment per subject Receives: Drug: nicotine
Prototype 3	Experimental	4mg nicotine lozenge administered orally as a single dose treatment per subject Receives: Drug: nicotine
Reference Therapy	Active comparator	4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject. Receives: Drug: nicotine

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 t, AUC (0-t)
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Measured: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Maximum Plasma Concentration (Cmax)
Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.
Measured: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Secondary outcomes (4)

AUC(0-inf)
Area under the plasma nicotine concentration-time curve from zero extrapolated to infinity was determined. AUC(0-inf) was based on the baseline adjusted nicotine plasma concentration data.
Measured: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Time to Maximum Plasma Concentration (Tmax)
Tmax was determined from plasma concentration time profiles. Tmax was based on the baseline adjusted nicotine plasma concentration data.
Measured: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Rate of Elimination (Kel)
Elimination rate constant for nicotine was calculated. Kel was based on the baseline adjusted nicotine plasma concentration data.
Measured: Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Plasma Half Life (t1/2)
Half-life of elimination of nicotine was determined. t1/2 was based on the baseline adjusted nicotine plasma concentration data.
Measured: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Timeline

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

Jun 2012Aug 2012

First posted20 Aug 2012 (estimated)
Study startJun 2012
Primary completionAug 2012
Study completionAug 2012

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01669122
Sponsor's protocol ID: RH01333
Status last verified: Oct 2014
First submitted: 16 Aug 2012
Last updated: 22 Jan 2015
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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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Cross-Over, Single Dose Pharmacokinetic Study of 4mg Nicotine Lozenges.
ClinicalTrials.gov ID: NCT01669122
Acronym / sponsor ID: RH01333
Conditions: Smoking Cessation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 20 Aug 2012 (estimated)
Results: Posted 22 Jan 2015

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
Prototype 1	Experimental	Drug: nicotine4mg nicotine lozenge administered orally as a single dose treatment per subject
Prototype 2	Experimental	Drug: nicotine4mg nicotine lozenge administered orally as a single dose treatment per subject
Prototype 3	Experimental	Drug: nicotine4mg nicotine lozenge administered orally as a single dose treatment per subject
Reference Therapy	Active comparator	Drug: nicotine4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject.

Who may qualify

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

Key inclusion criteria (1 listed)

smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.

Key exclusion criteria (1 listed)

inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing

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
nicotine4 mg nicotine lozenge experimental	Drug	Prototype 1, Prototype 2, Prototype 3, Reference Therapy

Primary outcome

Area Under the Curve From Time 0 to t, AUC (0-t)
Time frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Maximum Plasma Concentration (Cmax)
Time frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.

4 secondary outcomes

AUC(0-inf)
Time frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Time to Maximum Plasma Concentration (Tmax)
Time frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Rate of Elimination (Kel)
Time frame: Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing
Plasma Half Life (t1/2)
Time frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Results and safety

Results posted to the registry on 22 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Participants	40	39

Primary outcome: Area Under the Curve From Time 0 to t, AUC (0-t)

Time frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing. Mean (Standard Deviation). Unit: nanograms (ng)*hours (h)/milliliter (mL)

Measure	Test Lozenge (A) n = 38	Test Lozenge (B) n = 37	Test Lozenge (C) n = 39	Reference Lozenge n = 38
Value	89.14 (44.777)	87.38 (42.816)	86.60 (36.191)	91.97 (45.601)

Test Lozenge (A) vs Reference Lozenge: Treatment Ratio: 0.96 (90% CI 0.93 to 0.99)
Test Lozenge (B) vs Reference Lozenge: Treatment Ratio: 0.96 (90% CI 0.93 to 0.99)
Test Lozenge (C) vs Reference Lozenge: Treatment Ratio: 0.94 (90% CI 0.91 to 0.97)

Population analysed: Per protocol (PP) population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing. Mean (Standard Deviation). Unit: ng/mL

Measure	Test Lozenge (A) n = 38	Test Lozenge (B) n = 37	Test Lozenge (C) n = 39	Reference Lozenge n = 38
Value	18.50 (5.626)	18.39 (5.099)	17.41 (4.796)	18.97 (6.001)

Test Lozenge (A) vs Reference Lozenge: Treatment Ratio: 0.97 (90% CI 0.93 to 1.02)
Test Lozenge (B) vs Reference Lozenge: Treatment Ratio: 0.99 (90% CI 0.94 to 1.03)
Test Lozenge (C) vs Reference Lozenge: Treatment Ratio: 0.92 (90% CI 0.88 to 0.96)

Population analysed: PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the start of the treatment, and until 7 days following administration of the last dose of investigational product.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Lozenge (A)	0 of 38 (0%)	0 of 38 (0%)	Not reported
Test Lozenge (B)	0 of 37 (0%)	0 of 37 (0%)	Not reported
Test Lozenge (C)	0 of 39 (0%)	0 of 39 (0%)	Not reported
Reference Lozenge	0 of 38 (0%)	0 of 38 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
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 2 study testing nicotine in people with Smoking Cessation, run by GlaxoSmithKline at 1 site in India.

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 1 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 22 Jan 2015. 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 India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Jan 2015). 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 t, AUC (0-t) (time frame: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing). 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 NCT01669122.

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 22 Jan 2015.