A Nicotine Pharmacokinetics and Smoking Behaviour Study Examining Cigarette Ingredients

NCT03272295 | Completed

• 2 other identifiers: BAT1117009CA21208
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Smoking

Outcome Measures

Primary Outcomes (1)

• Cmax

  To assess the maximum nicotine concentration when subjects smoke a single cigarette

  -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

  -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff

• Tmax

  -5, 1, 2, 3, 4, 5, 6, 7, 8, 15, 60, 120, 180 and 240 minutes in relation to the first puff

• Puff Volume

  During the time required to smoke a single cigarette (up to 8 minutes)

• Puff duration

  During the time required to smoke a single cigarette (up to 8 minutes)

• Number of puffs

  During the time required to smoke a single cigarette (up to 8 minutes)

Study Arms (2)

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.

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.

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

Interventions

Reference cigarette OTHER

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.

Arm A; Arm B

Cigarette with carob bean extract OTHER

Based on reference cigarette with added ingredient

Arm A

Cigarette with cocoa powder OTHER

Based on reference cigarette with added ingredient

Arm A

Cigarette with fenugreek extract OTHER

Based on reference cigarette with added ingredient

Arm A

Cigarette with fig juice OTHER

Based on reference cigarette with added ingredient

Arm A

Cigarette with glycerol OTHER

Based on reference cigarette with added ingredient

Arm A

Cigarette with guaiacol OTHER

Based on reference cigarette with added ingredient

Arm B

Cigarette with liquorice extract powder OTHER

Based on reference cigarette with added ingredient

Arm B

Cigarette plus I-menthol OTHER

Based on reference cigarette with added ingredient

Arm B

Cigarette with propylene glycol OTHER

Based on reference cigarette with added ingredient

Arm B

Cigarette with sorbitol OTHER

Based on reference cigarette with added ingredient

Arm B

Cigarette with multiple ingredients OTHER

Based on reference cigarette plus propylene glycol, glycerol, liquorice extract powder, cocoa powder, carob bean extract, fig juice concentrate, maltol, guaiacol, geraniol, fenugreek extract.

Arm A; Arm B

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be:
• males or females 1.2. 21 to 55 years of age, inclusive, demonstrated by appropriate proof of identification.
• Subjects will have a:
• 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:
• 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
• 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.

You may not qualify if:

• 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:
• ≥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.
• 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:
• 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:

Sponsors & Collaborators

• British American Tobacco (Investments) Limited: lead
• Philip Morris Products S.A.: collaborator
• Imperial Brands PLC: collaborator
• Japan Tobacco Inc.: collaborator
• Korea Ginseng Corporation: collaborator

Study Sites (1)

Celerion

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

MeSH Terms

Conditions

Smoking

Interventions

Tobacco Products; Chocolate; fenugreek seed meal; Glycerol; Guaiacol; Propylene Glycol; Sorbitol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Methyl Ethers; Ethers; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Propylene Glycols; Glycols

Study Officials

• Johnston Stewart, MB

  Celerion GB Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A double-blind study in respect of the site (except pharmacy) and subjects.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: September 5, 2017
• Study Start: September 12, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 8, 2017
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

GB (1)