Healthy Volunteer SmokersPhase 1NCT00651352
A Single Dose Bioequivalence Study OfTwo Formulations Of Nicotine Lozenges
A Phase 1 study testing 4 mg nicotine lozenge, 2 mg nicotine lozenge and 2 mg nicotine prototype in people with Healthy Volunteer Smokers, run by GlaxoSmithKline.
Trial summary
Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated with a single dose or four study treatments in a randomized sequence. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Smokers
- What is being tested?
- 4 mg nicotine lozenge, 2 mg nicotine lozenge and 2 mg nicotine prototype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Mar 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is either male or female between 18 - 55 years of age inclusive.
- Subject has a BMI within the range 19-27 kg/m². [BMI = Weight (kg) ÷ Height (m)²].
- Subject admits to having smoked commercially-available cigarettes daily for the preceding 12 months and to routinely smoking his or her first cigarette within 30 minutes upon awakening.
- Subject is in good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities as assessed by medical history, physical examination, electrocardiogram (ECG) and clinical laboratory test results (hematology, biochemistry and urinalysis) are within normal limits.
- If female, subject of childbearing potential is practicing a reliable method of contraception in the opinion of the investigator.
- Subject understands and is willing, able, and likely to comply with all study procedures and restrictions.
- Subject demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.
Who cannot join
- If female, subject is pregnant, has a positive serum pregnancy test during screening, or is breast-feeding.
- Subject has a disease or condition that may interfere with the oral absorption of the study drugs.
- A medical history that, in the opinion of the investigator, might jeopardize the safety of the subject (e.g. rheumatoid arthritis, circulatory problems, recent myocardial infarction, cerebrovascular accident within 12 weeks prior to first study session, unstable or worsening angina pectoris, Prinzmetal's angina or severe cardiac arrhythmia).
- A medical history which, in the opinion of the investigator, might impact the validity of the study results and may require pharmacotherapy or prevent the subject from finishing the study.
- Oral surgery within 4 weeks of dosing, dental work or extractions within 2 weeks of dosing, or presence of any clinically significant (as determined by the principal investigator) oral pathology including lesions, sores or inflammation.
- Subject has used chewing tobacco or tobacco products other than cigarettes within 21 days of Visit 1.
Show all 18Show fewer
- Subject has abused alcohol or other substances within two years of screening. For the purposes of this study, alcohol abuse is defined as daily use of greater than two drinks per day.
- Subject has a positive urine drug screen for cannabinoids, amphetamine, cocaine, ecstasy, methamphetamine, or opiates.
- Subject has a positive serum hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) test result.
- Subject has known or suspected intolerance or hypersensitivity to any of the study materials or closely related compounds or any of their stated ingredients.
- Subject has a genetic deficiency with an inability to metabolize aspartame or phenylalanine, or has been diagnosed with phenylketonuria.
- Subject has participated in another clinical study or received an investigational drug within 30 days of the first study session or previously participated in this study.
- Subject has donated or experienced significant blood loss within 56 days of Visit 2, donated plasma within 7 days of Visit 2, or has a hemoglobin value of <12.0g/dL.
- Subject has been treated with any known enzyme-altering agents (e.g., barbiturates, phenothiazines, cimetidine, theophyllines) within 30 days prior to the first study session.
- Subject has used any nicotine replacement therapy within 21 days prior to the first study session.
- Subject has used any over-the-counter (OTC) medication or herbal supplements within 48 hours prior to administration of study treatment.
- Subject has used any prescription medication within 14 days prior to each study session, excluding hormonal contraceptive or hormone replacement therapy.
- Subject is a member of the study site staff or an employee of the sponsor.
About this study
Official title: A Single Dose Bioequivalence Study of 2mg and 4mg Nicotine Lozenges
Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated with a single dose or four study treatments in a randomized sequence.
- Conditions
- Healthy Volunteer Smokers
- Being tested
- 4 mg nicotine lozenge, 2 mg nicotine lozenge, 2 mg nicotine prototype, 4 mg nicotine prototype
- Keywords
- NRT, Bioequivalence, Nicotine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mg nicotine lozengeDrug
Also called Nicotine
marketed formulation
2 mg nicotine lozengeDrug
marketed formulation
2 mg nicotine prototypeDrug
2 mg
4 mg nicotine prototypeDrug
4 mg
| Study group | Role | What they receive |
|---|---|---|
| 2 mg nicotine prototype | Experimental | 2 mg nicotine prototype Receives: Drug: 2 mg nicotine prototype |
| 2 mg nicotine lozenge | Active comparator | marketed formulation Receives: Drug: 2 mg nicotine lozenge |
| 4 mg nicotine prototype | Experimental | 4 mg Receives: Drug: 4 mg nicotine prototype |
| 4 mg nicotine lozenge | Active comparator | 4 mg Receives: Drug: 4 mg nicotine lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise 4mg prototype lozenge to 4mg standard lozenge.
Measured: 12 hours
Secondary outcomes (2)
• To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise with the 4mg prototype lozenge to 4mg standard lozenge;
Measured: 12 hours
• To evaluate the safety of the 2mg and 4mg prototype lozenges.
Measured: Study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer SmokersStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651352
- Sponsor's protocol ID
- S3010567
- Status last verified
- Jun 2014
- First submitted
- 31 Mar 2008
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Bioequivalence Study of 2mg and 4mg Nicotine Lozenges
- ClinicalTrials.gov ID
- NCT00651352
- Acronym / sponsor ID
- S3010567
- Conditions
- Healthy Volunteer Smokers
- Keywords
- NRT, Bioequivalence, Nicotine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 2 Apr 2008 (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.
Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated with a single dose or four study treatments in a randomized sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 mg nicotine prototype | Experimental | Drug: 2 mg nicotine prototype2 mg nicotine prototype |
| 2 mg nicotine lozenge | Active comparator | Drug: 2 mg nicotine lozengemarketed formulation |
| 4 mg nicotine prototype | Experimental | Drug: 4 mg nicotine prototype4 mg |
| 4 mg nicotine lozenge | Active comparator | Drug: 4 mg nicotine lozenge4 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is either male or female between 18 - 55 years of age inclusive.
- Subject has a BMI within the range 19-27 kg/m². [BMI = Weight (kg) ÷ Height (m)²].
- Subject admits to having smoked commercially-available cigarettes daily for the preceding 12 months and to routinely smoking his or her first cigarette within 30 minutes upon awakening.
- Subject is in good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities as assessed by medical history, physical examination, electrocardiogram (ECG) and clinical laboratory test results (hematology, biochemistry and urinalysis) are within normal limits.
- If female, subject of childbearing potential is practicing a reliable method of contraception in the opinion of the investigator.
Key exclusion criteria (18 listed)
- If female, subject is pregnant, has a positive serum pregnancy test during screening, or is breast-feeding.
- Subject has a disease or condition that may interfere with the oral absorption of the study drugs.
- Subject has used chewing tobacco or tobacco products other than cigarettes within 21 days of Visit 1.
- Subject has abused alcohol or other substances within two years of screening. For the purposes of this study, alcohol abuse is defined as daily use of greater than two drinks per day.
- Subject has a positive urine drug screen for cannabinoids, amphetamine, cocaine, ecstasy, methamphetamine, or opiates.
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 |
|---|---|---|
| 4 mg nicotine lozengeAlso: Nicotinemarketed formulation | Drug | 4 mg nicotine lozenge |
| 2 mg nicotine lozengemarketed formulation | Drug | 2 mg nicotine lozenge |
| 2 mg nicotine prototype2 mg | Drug | 2 mg nicotine prototype |
| 4 mg nicotine prototype4 mg | Drug | 4 mg nicotine prototype |
Primary outcome
To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise 4mg prototype lozenge to 4mg standard lozenge.
Time frame: 12 hours
2 secondary outcomes
• To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise with the 4mg prototype lozenge to 4mg standard lozenge;
Time frame: 12 hours
• To evaluate the safety of the 2mg and 4mg prototype lozenges.
Time frame: Study period
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 24 Nov 2014.
Related trials for Healthy Volunteer Smokers
RecruitingPhase 1
Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease
Healthy, Healthy Smoker
Active, not recruiting
Physical Activity in Promoting Smoking Cessation in African Americans
Current Smoker, Healthy Subject
Active, not recruiting
Different Modes of Universal Adhesive in Smokers and Non-Smokers
Healthy Participant
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4 mg nicotine lozenge, 2 mg nicotine lozenge and 2 mg nicotine prototype in people with Healthy Volunteer Smokers, run by GlaxoSmithKline.
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 7 inclusion and 18 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 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise 4mg prototype lozenge to 4mg standard lozenge. (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2014.