SmokingPhase 1NCT01702519

A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

A Phase 1 study testing nicotine in people with Smoking, 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.

Trial summary

Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: nicotine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Mar 2012to Mar 2012
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

BMI 19-27 kg/m2
smokes >10 cigarettes per day for preceeding 6 months

Who cannot join

inability to stop smoking during study

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

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

What participants receive

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

nicotineDrug
nicotine transdermal patch

Study groups in NCT01702519
Study group	Role	What they receive
Reference	Active comparator	nicotine transdermal patch with the existing polyisobutylene adhesive Receives: Drug: nicotine
Treatement	Active comparator	nicotine transdermal patch with the alternate polyisobutylene adhesive 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 the Last Quantifiable Sample, AUC(0-t)
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Measured: Baseline to 32 hours
Maximum Measured Plasma Concentration (Cmax)
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.
Measured: Baseline to 32 hours

Secondary outcomes (4)

Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma nicotine concentration time curve from zero extrapolated to infinity was determined by plasma concentration time profile of nicotine. Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -inf) was based on the baseline adjusted nicotine plasma concentration data.
Measured: Baseline to 32 hours
Time to Maximum Plasma Concentration (Tmax)
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Time to Maximum Plasma Concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points; immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application of the patch. Patch was then removed after the collection of 24 hour blood sample. Tmax was based on the baseline adjusted nicotine plasma concentration data.
Measured: Baseline to 32 hours
Plasma Half-life (t1/2)
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. The elimination half-life of nicotine was determined by from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Plasma half-life (t1/2) was based on the baseline adjusted nicotine plasma concentration data
Measured: Baseline to 32 hours
Rate of Elimination (Kel)
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Elimination rate constant for nicotine was determined from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Elimination rate constant for nicotine was based on the baseline adjusted nicotine plasma concentration data.
Measured: Baseline to 32 hours

Timeline

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

Mar 2012Mar 2012

First posted8 Oct 2012 (estimated)
Study startMar 2012
Primary completionMar 2012
Study completionMar 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 SmokingStudies 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
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01702519
Sponsor's protocol ID: RH01418
Status last verified: Feb 2015
First submitted: 4 Oct 2012
Last updated: 20 Mar 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 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
ClinicalTrials.gov ID: NCT01702519
Acronym / sponsor ID: RH01418
Conditions: Smoking
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 8 Oct 2012 (estimated)
Results: Posted 11 Feb 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

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Reference	Active comparator	Drug: nicotinenicotine transdermal patch with the existing polyisobutylene adhesive
Treatement	Active comparator	Drug: nicotinenicotine transdermal patch with the alternate polyisobutylene adhesive

Who may qualify

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

Key inclusion criteria (2 listed)

BMI 19-27 kg/m2
smokes >10 cigarettes per day for preceeding 6 months

Key exclusion criteria (1 listed)

inability to stop smoking during study

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
nicotinenicotine transdermal patch	Drug	Reference, Treatement

Primary outcome

Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)
Time frame: Baseline to 32 hours
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Maximum Measured Plasma Concentration (Cmax)
Time frame: Baseline to 32 hours
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.

4 secondary outcomes

Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)
Time frame: Baseline to 32 hours
Time to Maximum Plasma Concentration (Tmax)
Time frame: Baseline to 32 hours
Plasma Half-life (t1/2)
Time frame: Baseline to 32 hours
Rate of Elimination (Kel)
Time frame: Baseline to 32 hours

Results and safety

Results posted to the registry on 11 Feb 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
Test Then Reference Patch	20	20
Reference Then Test Patch	20	20

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

Time frame: Baseline to 32 hours. Mean (Standard Deviation). Unit: nanogram (ng)*hour (hr)/milliliter (mL)

Measure	Test Patch n = 38	Reference Patch n = 38
Value	494.54 (115.075)	528.43 (129.762)

Test Patch vs Reference Patch: Treatment Ratio: 0.946 (90% CI 0.912 to 0.982), Treatment Ratio

Population analysed: Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.

Primary outcome: Maximum Measured Plasma Concentration (Cmax)

Time frame: Baseline to 32 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Test Patch n = 38	Reference Patch n = 38
Value	22.31 (4.986)	23.50 (5.917)

Test Patch vs Reference Patch: Treatment Ratio: 0.962 (90% CI 0.92 to 1.00), Treatment Ratio

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Patch	0 of 38 (0%)	22 of 38 (57.9%)	Not reported
Reference Patch	0 of 39 (0%)	26 of 39 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 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 1 study testing nicotine in people with Smoking, 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 20 Mar 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 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 11 Feb 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 the Last Quantifiable Sample, AUC(0-t) (time frame: Baseline to 32 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 NCT01702519.

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 20 Mar 2015.