Healthy VolunteersEarly Phase 1NCT02474849
Pharmacokinetic Study Comparing Nicotine Delivery From E-cigarettes and a Conventional Cigarette in Healthy Subjects
A Early Phase 1 study testing Use electronic cigarette or smoke conventional cigarette in people with Healthy Volunteers, run by British American Tobacco (Investments) Limited at 1 site in United States.
Trial summary
This study will compare nicotine delivery, heart rate, puffing parameters and product satisfaction in healthy subjects either using several different types of electronic cigarettes or smoking a conventional cigarette. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Use electronic cigarette or smoke conventional cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2015
- Phase
- Early 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prior to study start, subjects must be daily users of newer generation e-cigarette devices which they have used regularly for a minimum of three months. The solutions used in their e-cigarettes must contain nicotine. Subjects must also be occasional smokers of combustible cigarettes (lower limit of 1 cigarette per month; upper limit of 5 cigarettes per week). Product use status will be confirmed with a urinary cotinine level of ≥200ng/ml (determined using NicAlert cotinine test kit) at screening.
- Subjects will be males or non-pregnant, non-lactating females, and between 21 and 55 years of age inclusive. Age verification will be performed by checking of Federal or state-issued ID (e.g. passport or driving licence) during screening.
- Women of child-bearing potential should be using one of the following acceptable methods of contraception : combined (oestrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception, either oral, injected or implanted, associated with inhibition of ovulation; progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide.
- Women of non-childbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year and must have a negative urine pregnancy test result during screening. Women who are surgically sterile must provide documentation of the procedure by an operative report.
- Male subjects must use an approved method of birth control during the entire study. These subjects must not donate sperm during this time.
- Subjects must be in good health as determined by medical history, vital signs, blood biochemistry, haematology, urinalysis and physical examination.
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- Subjects must have a body mass index (BMI) between 18 and 30 kg/m2 inclusive. Male subjects must have a weight between 60 and 120kg and female subjects between 50 and 100kg.
- No clinically significant abnormalities in blood pressure values.
- Subjects will have negative results for the urinary drug of abuse screening and ethanol test.
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
- To be confirmed during each clinic visit:
- 1. Abstinence from tobacco and nicotine products will be confirmed by an exhaled breath CO reading <10ppm.
Who cannot join
- Subjects who have a history of, or clinically active significant, neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological disease or other major disorders.
- Subjects with significant allergies who in the opinion of the Principal Investigator should not be included.
- Subjects who have been diagnosed with urticaria (hives) or asthma.
- Persons who have a history of urticaria (hives) in response to any product.
- Subjects with a recent history of or current drug or alcohol abuse who in the opinion of the Investigator should not be included. Excessive intake of alcohol within the last 6 months, defined as a regular maximum weekly intake of greater than 7 drinks for women or 14 drinks for men. One drink is defined as one pint of regular beer (5% alcohol), 200 ml of wine (12% alcohol), or 25 ml of distilled spirits (40% alcohol).
- Subjects with an inability to communicate well with the Investigator/study staff (i.e., language problem, poor mental development or impaired cerebral function).
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- Subjects who are participating in another clinical research study or who have participated in a clinical research study in the last 3 months.
- Subjects who have had treatment with prescription medications within 21 days or over-the-counter medication within 24 hours of the planned first product use occasion, except for those stated in the Inclusion Criteria. For all subjects, prescribed use of blood pressure (beta blockers) and lipid lowering (statin) medications are permitted.
- Subjects who have used any drugs or substances (except tobacco) known to be strong inducers or inhibitors of any CYP enzymes (formerly known as cytochrome P450 enzymes) within a 28 days period prior to first product administration. For a list of such drugs and substances, please refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/.
- Subjects who have had any treatment with smoking cessation medications (e.g. Bupropion, Chantix or any NRT) within 30 days of the planned first product use occasion.
- Subjects with any other clinically significant medical history, in the Investigator's opinion, including conditions which might affect drug absorption, metabolism or excretion.
- Female subjects, who are pregnant or become pregnant during the course of the study.
- Subjects who have lost or donated more than 450ml of blood within the 3 months preceding the first product administration.
- Subjects who are currently trying to stop smoking or to stop using e-cigarettes, or considering stopping in the next two months.
- Subjects who are unwilling or unable to comply with the study requirements.
- Subjects who in the opinion of the Investigator should not participate in the study for any other reason.
- To be re-confirmed during each clinic visit:
- Subject continues to meet all screening exclusion criteria.
- Receipt of any medication since screening visit that may have an impact on the safety and objectives of the study (at the Principal Investigator's discretion).
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Clinical Trials
Burbank, California, 91505
About this study
Official title: A Pharmacokinetic Study to Compare Nicotine Delivery From e Cigarettes and a Conventional Cigarette in Healthy Subjects During a Brief Period of ad Libitum Use
This study will compare nicotine delivery, heart rate, puffing parameters and product satisfaction in healthy subjects either using several different types of electronic cigarettes or smoking a conventional cigarette.
- Conditions
- Healthy Volunteers
- Being tested
- Use electronic cigarette or smoke conventional cigarette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use electronic cigarette or smoke conventional cigaretteOther
Use of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period
| Study group | Role | What they receive |
|---|---|---|
| Conventional cigarette | Active comparator | Not described Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| First-generation e-cigarette | Experimental | Not described Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| Rechargeable cig-like e-cigarette | Experimental | Not described Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| Closed modular system e-cigarette A | Experimental | Not described Receives: Other: Use electronic cigarette or smoke conventional cigarette |
| Closed modular system e-cigarette B | Experimental | Not described Receives: Other: Use electronic cigarette or smoke conventional cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nicotine concentration (Cmax)
Nicotine pharmacokinetics
Measured: -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Plasma nicotine concentration (Tmax)
Nicotine pharmacokinetics
Measured: -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Plasma nicotine concentration (AUC0-60)
Nicotine pharmacokinetics
Measured: -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Secondary outcomes (4)
Change in heart rate
Pharmacodynamics
Measured: 5 minutes before, during, and 5 minutes after puffing period
Number of puffs taken
Measured: During 5 minute ad libitum puffing period
Duration of puffs taken
Measured: During 5 minute ad libitum puffing period
Subjective measurement of product satisfaction
Measured: After 5 minute product use period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- British American Tobacco (Investments) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LA Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Mitchell Nides, PhD, Principal investigator, Los Angeles Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474849
- Sponsor's protocol ID
- BAT4215006
- Status last verified
- Sep 2015
- First submitted
- 11 Jun 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study to Compare Nicotine Delivery From e Cigarettes and a Conventional Cigarette in Healthy Subjects During a Brief Period of ad Libitum Use
- ClinicalTrials.gov ID
- NCT02474849
- Acronym / sponsor ID
- BAT4215006
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- British American Tobacco (Investments) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- LA Clinical Trials
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Jun 2015 (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.
This study will compare nicotine delivery, heart rate, puffing parameters and product satisfaction in healthy subjects either using several different types of electronic cigarettes or smoking a conventional cigarette.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Conventional cigarette | Active comparator | Other: Use electronic cigarette or smoke conventional cigarette |
| First-generation e-cigarette | Experimental | Other: Use electronic cigarette or smoke conventional cigarette |
| Rechargeable cig-like e-cigarette | Experimental | Other: Use electronic cigarette or smoke conventional cigarette |
| Closed modular system e-cigarette A | Experimental | Other: Use electronic cigarette or smoke conventional cigarette |
| Closed modular system e-cigarette B | Experimental | Other: Use electronic cigarette or smoke conventional cigarette |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Prior to study start, subjects must be daily users of newer generation e-cigarette devices which they have used regularly for a minimum of three months. The solutions used in their e-cigarettes must contain nicotine. Subjects must also be occasional smokers of combustible cigarettes (lower limit of 1 cigarette per month; upper limit of 5 cigarettes per week). Product use status will be confirmed with a urinary cotinine level of ≥200ng/ml (determined using NicAlert cotinine test kit) at screening.
- Subjects will be males or non-pregnant, non-lactating females, and between 21 and 55 years of age inclusive. Age verification will be performed by checking of Federal or state-issued ID (e.g. passport or driving licence) during screening.
- Women of child-bearing potential should be using one of the following acceptable methods of contraception : combined (oestrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception, either oral, injected or implanted, associated with inhibition of ovulation; progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide.
- Women of non-childbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year and must have a negative urine pregnancy test result during screening. Women who are surgically sterile must provide documentation of the procedure by an operative report.
- Male subjects must use an approved method of birth control during the entire study. These subjects must not donate sperm during this time.
Key exclusion criteria (19 listed)
- Subjects who have a history of, or clinically active significant, neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological disease or other major disorders.
- Subjects with significant allergies who in the opinion of the Principal Investigator should not be included.
- Subjects who have been diagnosed with urticaria (hives) or asthma.
- Persons who have a history of urticaria (hives) in response to any product.
- Subjects with a recent history of or current drug or alcohol abuse who in the opinion of the Investigator should not be included. Excessive intake of alcohol within the last 6 months, defined as a regular maximum weekly intake of greater than 7 drinks for women or 14 drinks for men. One drink is defined as one pint of regular beer (5% alcohol), 200 ml of wine (12% alcohol), or 25 ml of distilled spirits (40% alcohol).
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 |
|---|---|---|
| Use electronic cigarette or smoke conventional cigaretteUse of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period | Other | Closed modular system e-cigarette A, Closed modular system e-cigarette B, Conventional cigarette, First-generation e-cigarette, Rechargeable cig-like e-cigarette |
Primary outcome
Plasma nicotine concentration (Cmax)
Time frame: -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Nicotine pharmacokinetics
Plasma nicotine concentration (Tmax)
Time frame: -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Nicotine pharmacokinetics
Plasma nicotine concentration (AUC0-60)
Time frame: -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette
Nicotine pharmacokinetics
4 secondary outcomes
Change in heart rate
Time frame: 5 minutes before, during, and 5 minutes after puffing period
Number of puffs taken
Time frame: During 5 minute ad libitum puffing period
Duration of puffs taken
Time frame: During 5 minute ad libitum puffing period
Subjective measurement of product satisfaction
Time frame: After 5 minute product use 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 15 Sep 2015.
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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.
Mitchell Nides, PhD principal investigator
Los Angeles Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Use electronic cigarette or smoke conventional cigarette in people with Healthy Volunteers, run by British American Tobacco (Investments) Limited 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 12 inclusion and 19 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 15 Sep 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Plasma nicotine concentration (Cmax) (time frame: -5, 1, 3, 5, 6, 7, 9, 15, 40, and 60 minutes relative to the first puff on the cigarette/e-cigarette). The study lists 3 primary outcomes in all. 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 15 Sep 2015.