A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
1 other identifier
interventional
24
1 country
1
Brief Summary
This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes. The study investigates combustible and heated tobacco (HT) products in a cross-over design, including pharmacokinetic evaluation, subjective questionnaire assessments, as well as safety evaluation. Subjects will perform a screening visit and a 5-day confinement period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started Oct 2021
Shorter than P25 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedFirst Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedResults Posted
Study results publicly available
February 3, 2025
CompletedFebruary 3, 2025
January 1, 2025
2 months
July 6, 2022
August 30, 2024
January 6, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Nicotine Cmax
Maximum measured plasma nicotine concentration, baseline-adjusted
5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
Nicotine AUCt
The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, baseline-adjusted
5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
Secondary Outcomes (3)
Urge to Smoke Pre-Use
10 minutes prior to the start of the product use session
Urge to Smoke Post-Use
At 240 min following the start of study product use
Smoking Urges Emax
10 minutes prior to the start of the product use session, and at 4, 8, 15, 45, 60, 210 and 240 minutes following the start of study product use
Study Arms (4)
Product sequence ABCD
EXPERIMENTALSubjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4
Product sequence BDAC
EXPERIMENTALSubjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4
Product sequence CADB
EXPERIMENTALSubjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4
Product sequence DCBA
EXPERIMENTALSubjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4
Interventions
Heated tobacco (HT) device with Intense HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Heated tobacco (HT) device with Regular HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Heated tobacco (HT) device with Menthol HT sticks, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Subject's own brand combustible cigarette, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Eligibility Criteria
You may qualify if:
- Reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to Screening
- Has a positive urine cotinine (\>500 ng/mL) at Screening
- Has an exhaled carbon monoxide \>10 ppm at Screening
- A female subject of childbearing potential must use contraception
- Male subject must use contraception
You may not qualify if:
- Has a history or presence of clinically significant disease or condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results.
- Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening
- Has a fever (\>38.05°C) at Screening or check-in
- Has a history or presence of drug or alcohol abuse within 24 months of Check-in
- Pregnant or lactating females
- Has used any prescription smoking cessation treatments within 3 months prior to Check-in
- Is planning to quit smoking during the study or within the next 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion
Belfast, Nothern Ireland, BT9 6AD, United Kingdom
MeSH Terms
Interventions
Results Point of Contact
- Title
- Libby Clarke
- Organization
- Imperial Brands PLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2022
First Posted
July 15, 2022
Study Start
October 1, 2021
Primary Completion
November 30, 2021
Study Completion
November 30, 2021
Last Updated
February 3, 2025
Results First Posted
February 3, 2025
Record last verified: 2025-01