Healthy VolunteersNCT03272295
A Nicotine Pharmacokinetics and Smoking Behaviour Study Examining Cigarette Ingredients
A study testing Reference cigarette, Cigarette with carob bean extract and Cigarette with cocoa powder in people with Healthy Volunteers and Smoking, run by British American Tobacco (Investments) Limited at 1 site in United Kingdom.
Trial summary
This study will compare nicotine delivery and smoking behaviour in healthy subjects using several combustible cigarette prototypes containing different ingredients which are commonly used in the European Union. 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, Smoking
- What is being tested?
- Reference cigarette, Cigarette with carob bean extract and Cigarette with cocoa powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Sep 2017to 8 Dec 2017
- Phase
- Interventional
- 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
- Subjects will be:
- 1.1. males or females 1.2. 21 to 55 years of age, inclusive, demonstrated by appropriate proof of identification.
- Subjects will have a:
- 2.1. BMI of 18.5 to 30.0 kg/m2, inclusive 2.2. body weight exceeding 52 kg (males) or 45 kg (females)
- Subjects will be in good health, as judged by the PI or the appropriately qualified designee based on:
- 3.1. medical history 3.2. physical examination 3.3. vital signs assessment 3.4. 12-lead ECG 3.5. clinical laboratory evaluations 3.6. lung function tests
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- Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions.
- Subjects must demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the PI or the appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the PI or the appropriately qualified designee.
- Subjects will be willing to refrain from consuming alcohol within 24 hours prior to Admission.
- Subjects will be regular smokers of factory made, non-menthol cigarettes whose chosen brand is within the ISO tar bands 6 to 10 mg, inclusive and should not change their usual brand cigarette for the duration of the study.
- Subjects will have smoked their chosen brand for a minimum of 6 months and will have smoked for at least 3 years prior to Screening, and will typically smoke at least 10 and a maximum of 30 CPD.
- Subjects must have a urine cotinine level >200 ng/mL and an ECO measurement of >10 ppm at Screening.
- Subjects will be willing to use the study products and smoke only the study products provided to them during clinical confinement and to abstain from smoking when required.
Who cannot join
- Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception (i.e., a condom with spermicide) in addition to a second highly effective method of contraception used by their female partners or to refrain from donating sperm from Admission for Visit 1 until 5-7 days after Discharge.
- Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (i.e., a condom with spermicide) from the time of signing the ICF until 5-7 days after Discharge.
- Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and at each Admission. Any female subject who becomes pregnant during this study will be withdrawn.
- Subjects who have donated:
- 4.1. ≥450 mL of blood within 90 days prior to Admission 4.2. plasma in the 7 days prior to Admission 4.3. platelets in the 6 weeks prior to Admission
- Subjects who have an acute illness (e.g., upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to Admission.
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- Subjects who have used any nicotine or tobacco product other than commercially manufactured non-menthol, filter cigarettes within 14 days of Screening.
- Subjects who are self-reported non-inhalers (smokers who draw smoke from the cigarette into the mouth and throat but who do not inhale). Subjects who are determined as non-inhalers at Screening will be excluded.
- Subjects who, prior to enrolment, are planning to quit smoking in the next 12 months of Screening. All subjects will be informed that they are free to quit smoking and withdraw from the study at any time. Any subject who decides to quit smoking will be directed to appropriate stop smoking services
- Subjects who have a significant history of alcoholism or drug/chemical abuse within 24 months prior to Screening, as determined by the PI or the appropriately qualified designee.
- Subjects who have a positive urine drugs of abuse or alcohol screen (confirmed by repeat) at Screening or Admission.
- Subjects who:
- 11.1. have serum hepatitis 11.2. are carriers of the hepatitis B surface antigen (HBsAg) 11.3. are carriers of the hepatitis C antibody 11.4. have a positive result for the test for human immunodeficiency virus (HIV) antibodies.
- Subjects who have used prescription or OTC bronchodilator medication (e.g., inhaled or oral β-adrenergic agonists) to treat a chronic condition within the 12 months prior to the first Admission (Visit 1) and throughout the study.
- Subjects who have received any medications or substances (other than tobacco) which:
- 13.1. are known to be strong inducers or inhibitors of CYP enzymes within 14 days or 5 half-lives of the drug (whichever is longer) prior to the first Admission (Visit 1) and throughout the study.
- Subjects who are planning to undergo significant lifestyle changes during the study e.g., big change in exercise levels.
- Subjects who are unable to communicate effectively with the PI/study staff (i.e., language problem, poor mental development, or impaired cerebral function).
- Subjects who are unwilling or unable to comply with the study requirements.
- Employees, and immediate relatives, of the tobacco industry or the clinical site.
- Subjects who are still participating in another clinical study (e.g., attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first Admission (Visit 1).
- Subjects who have any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests (forced expiratory volume in 1 second/ forced vital capacity [FEV1/FVC]), or clinical laboratory panel, unless deemed not clinically significant by the PI or the appropriately qualified designee.
- Subjects who have, or who have had a history of, any clinically significant neurological, gastrointestinal, renal (including urinary tract infection or nephrolithiasis), hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the PI or the appropriately qualified designee, would jeopardise the safety of the subject or impact on the validity of the study results.
- Subjects who have previously been diagnosed with any form of malignancy.
- Subjects who have any clinically significant abnormal laboratory safety findings at Screening and prior to first product use, as determined by the PI or the appropriately qualified designee (1 repeat assessment is acceptable).
- Subjects who have previously been randomised into or withdrawn from this study.
- Subjects who, in the opinion of the PI or the appropriately qualified designee, should not participate in this study.
- Compliance with all inclusion and exclusion criteria will be reaffirmed at each study Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled, Double-Blind Study to Examine Nicotine Pharmacokinetics and Smoking Behaviour in Healthy Smokers When Smoking Cigarettes Containing Different Commonly Used Ingredients
This study will compare nicotine delivery and smoking behaviour in healthy subjects using several combustible cigarette prototypes containing different ingredients which are commonly used in the European Union.
- Conditions
- Healthy Volunteers, Smoking
- Being tested
- Reference cigarette, Cigarette with carob bean extract, Cigarette with cocoa powder, Cigarette with fenugreek extract, Cigarette with fig juice
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference cigaretteOther
The reference product is based on a commercially-available king-size cigarette design (length 83 mm, circumference 24.6 mm) with a single segment cellulose acetate filter and tobacco blend recipe without ingredients.
Cigarette with carob bean extractOther
Based on reference cigarette with added ingredient
Cigarette with cocoa powderOther
Based on reference cigarette with added ingredient
Cigarette with fenugreek extractOther
Based on reference cigarette with added ingredient
Cigarette with fig juiceOther
Based on reference cigarette with added ingredient
Cigarette with glycerolOther
Based on reference cigarette with added ingredient
Cigarette with guaiacolOther
Based on reference cigarette with added ingredient
Cigarette with liquorice extract powderOther
Based on reference cigarette with added ingredient
Cigarette plus I-mentholOther
Based on reference cigarette with added ingredient
Cigarette with propylene glycolOther
Based on reference cigarette with added ingredient
Cigarette with sorbitolOther
Based on reference cigarette with added ingredient
Cigarette with multiple ingredientsOther
Based on reference cigarette plus propylene glycol, glycerol, liquorice extract powder, cocoa powder, carob bean extract, fig juice concentrate, maltol, guaiacol, geraniol, fenugreek extract.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Reference product (product 1) x 2, Single ingredients products 2, 3, 4, 5, 6 and Multiple ingredient product (product 12). Single cigarette each for nicotine PK assessment and smoking behaviour assessment. Receives: Other: Reference cigarette; Other: Cigarette with carob bean extract; Other: Cigarette with cocoa powder; Other: Cigarette with fenugreek extract; Other: Cigarette with fig juice; Other: Cigarette with glycerol; Other: Cigarette with multiple ingredients |
| Arm B | Experimental | Reference product (product 1), Single ingredients products 7, 8, 9, 10, 11 and Multiple ingredient product (product 12). Single cigarette each for nicotine PK assessment and smoking behaviour assessment. Receives: Other: Reference cigarette; Other: Cigarette with guaiacol; Other: Cigarette with liquorice extract powder; Other: Cigarette plus I-menthol; Other: Cigarette with propylene glycol; Other: Cigarette with sorbitol; Other: Cigarette with multiple ingredients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
To assess the maximum nicotine concentration when subjects smoke a single cigarette
Measured: -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff
Secondary outcomes (7)
AUC0-last
To assess the area under the concentration curve from time 0 to last the time-point when subjects smoke a single cigarette
Measured: -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff
Tmax
To assess the time to maximum nicotine concentration when subjects smoke a single cigarette
Measured: -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff
Puff Volume
To assess puff volume when subjects smoke a single cigarette
Measured: During the time required to smoke a single cigarette (up to 8 minutes)
Puff duration
To assess puff duration when subjects smoke a single cigarette
Measured: During the time required to smoke a single cigarette (up to 8 minutes)
Number of puffs
To assess number of puffs when subjects smoke a single cigarette
Measured: During the time required to smoke a single cigarette (up to 8 minutes)
Inhalation volume
To assess inhalation volume when subjects smoke a single cigarette
Measured: During the time required to smoke a single cigarette (up to 8 minutes)
Exhalation volume
To assess exhalation volume when subjects smoke a single cigarette
Measured: During the time required to smoke a single cigarette (up to 8 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start12 Sep 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- British American Tobacco (Investments) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philip Morris Products S.A., Imperial Brands PLC, Japan Tobacco Inc., Korea Ginseng Corporation
- Responsible party
- Sponsor
- Investigators
- Johnston Stewart, MB, Principal investigator, Celerion GB Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272295
- Sponsor's protocol ID
- BAT1117009
- Other IDs
- CA21208
- Status last verified
- Dec 2022
- First submitted
- 15 Aug 2017
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Double-Blind Study to Examine Nicotine Pharmacokinetics and Smoking Behaviour in Healthy Smokers When Smoking Cigarettes Containing Different Commonly Used Ingredients
- ClinicalTrials.gov ID
- NCT03272295
- Acronym / sponsor ID
- BAT1117009
- Conditions
- Healthy Volunteers, Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- British American Tobacco (Investments) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Philip Morris Products S.A., Imperial Brands PLC, Japan Tobacco Inc., Korea Ginseng Corporation
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 5 Sep 2017 (actual)
- 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 and smoking behaviour in healthy subjects using several combustible cigarette prototypes containing different ingredients which are commonly used in the European Union.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: Reference cigarette, Other: Cigarette with carob bean extract, Other: Cigarette with cocoa powder, Other: Cigarette with fenugreek extract, Other: Cigarette with fig juice, Other: Cigarette with glycerol, Other: Cigarette with multiple ingredientsReference product (product 1) x 2, Single ingredients products 2, 3, 4, 5, 6 and Multiple ingredient product (product 12). Single cigarette each for nicotine PK assessment and smoking behaviour assessment. |
| Arm B | Experimental | Other: Reference cigarette, Other: Cigarette with guaiacol, Other: Cigarette with liquorice extract powder, Other: Cigarette plus I-menthol, Other: Cigarette with propylene glycol, Other: Cigarette with sorbitol, Other: Cigarette with multiple ingredientsReference product (product 1), Single ingredients products 7, 8, 9, 10, 11 and Multiple ingredient product (product 12). Single cigarette each for nicotine PK assessment and smoking behaviour assessment. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects will be:
- 1.1. males or females 1.2. 21 to 55 years of age, inclusive, demonstrated by appropriate proof of identification.
- Subjects will have a:
- 2.1. BMI of 18.5 to 30.0 kg/m2, inclusive 2.2. body weight exceeding 52 kg (males) or 45 kg (females)
- Subjects will be in good health, as judged by the PI or the appropriately qualified designee based on:
Key exclusion criteria (28 listed)
- Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception (i.e., a condom with spermicide) in addition to a second highly effective method of contraception used by their female partners or to refrain from donating sperm from Admission for Visit 1 until 5-7 days after Discharge.
- Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (i.e., a condom with spermicide) from the time of signing the ICF until 5-7 days after Discharge.
- Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening and at each Admission. Any female subject who becomes pregnant during this study will be withdrawn.
- Subjects who have donated:
- 4.1. ≥450 mL of blood within 90 days prior to Admission 4.2. plasma in the 7 days prior to Admission 4.3. platelets in the 6 weeks prior to Admission
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 |
|---|---|---|
| Reference cigaretteThe reference product is based on a commercially-available king-size cigarette design (length 83 mm, circumference 24.6 mm) with a single segment cellulose acetate filter and tobacco blend recipe without ingredients. | Other | Arm A, Arm B |
| Cigarette with carob bean extractBased on reference cigarette with added ingredient | Other | Arm A |
| Cigarette with cocoa powderBased on reference cigarette with added ingredient | Other | Arm A |
| Cigarette with fenugreek extractBased on reference cigarette with added ingredient | Other | Arm A |
| Cigarette with fig juiceBased on reference cigarette with added ingredient | Other | Arm A |
| Cigarette with glycerolBased on reference cigarette with added ingredient | Other | Arm A |
| Cigarette with guaiacolBased on reference cigarette with added ingredient | Other | Arm B |
| Cigarette with liquorice extract powderBased on reference cigarette with added ingredient | Other | Arm B |
| Cigarette plus I-mentholBased on reference cigarette with added ingredient | Other | Arm B |
| Cigarette with propylene glycolBased on reference cigarette with added ingredient | Other | Arm B |
| Cigarette with sorbitolBased on reference cigarette with added ingredient | Other | Arm B |
| Cigarette with multiple ingredientsBased on reference cigarette plus propylene glycol, glycerol, liquorice extract powder, cocoa powder, carob bean extract, fig juice concentrate, maltol, guaiacol, geraniol, fenugreek extract. | Other | Arm A, Arm B |
Primary outcome
Cmax
Time frame: -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff
To assess the maximum nicotine concentration when subjects smoke a single cigarette
7 secondary outcomes
AUC0-last
Time frame: -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff
Tmax
Time frame: -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff
Puff Volume
Time frame: During the time required to smoke a single cigarette (up to 8 minutes)
Puff duration
Time frame: During the time required to smoke a single cigarette (up to 8 minutes)
Number of puffs
Time frame: During the time required to smoke a single cigarette (up to 8 minutes)
Inhalation volume
Time frame: During the time required to smoke a single cigarette (up to 8 minutes)
Exhalation volume
Time frame: During the time required to smoke a single cigarette (up to 8 minutes)
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 7 Dec 2022.
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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.
Johnston Stewart, MB principal investigator
Celerion GB Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reference cigarette, Cigarette with carob bean extract and Cigarette with cocoa powder in people with Healthy Volunteers and Smoking, run by British American Tobacco (Investments) Limited 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 13 inclusion and 28 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 7 Dec 2022. 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.
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?
Cmax (time frame: -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff). 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 7 Dec 2022; AzTrials last refreshed its copy on 2 Nov 2026.