Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco and Heated Herbal Products Compared With Combustible Cigarettes
1 other identifier
interventional
25
1 country
1
Brief Summary
This is a randomised, cross-over, open-label, confinement study conducted in 25 adult male or female smokers of combustible cigarettes (CCs). The study investigates combustible cigarettes, heated tobacco products (HTPs), and Heated Herbal Products (HHPs), with endpoints including pharmacokinetic evaluation, and subjective effects. Subjects will perform a Screening Visit and one Study Visit, including a 6-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 Jul 2023
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
July 7, 2023
CompletedFirst Submitted
Initial submission to the registry
October 10, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2023
CompletedResults Posted
Study results publicly available
February 3, 2025
CompletedFebruary 3, 2025
January 1, 2025
4 months
October 10, 2023
May 23, 2024
January 6, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Nicotine Cmax
Maximum measured plasma nicotine concentration, following the controlled product use session
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, following the controlled product use session
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 (4)
Urge to Smoke Pre-use
10 minutes prior to the start of the product use session
Urge to Smoke Post-use
At 240 minutes following the start of study product use
Urge to Smoke Emax
10 minutes prior to the start of the product use session and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use.
Puff Count
Hours 2-4 of the 4-hour ad libitum product use session
Study Arms (5)
Product use sequence ABECD
EXPERIMENTALSubjects use Product A on Day 1, Product B on Day 2, Product E on Day 3 and Product C on Day 4 and Product D on Day 5.
Product use sequence BCADE
EXPERIMENTALSubjects use Product B on Day 1, Product C on Day 2, Product A on Day 3 and Product D on Day 4 and Product E on Day 5.
Product use sequence CDBEA
EXPERIMENTALSubjects use Product C on Day 1, Product D on Day 2, Product B on Day 3 and Product E on Day 4 and Product A on Day 5.
Product use sequence DECAB
EXPERIMENTALSubjects use Product D on Day 1, Product E on Day 2, Product C on Day 3 and Product A on Day 4 and Product B on Day 5.
Product use sequence EADBC
EXPERIMENTALSubjects use Product E on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4 and Product C on Day 5.
Interventions
Product A, 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), followed by an ad-libitum, 4-hour product use session on the same day.
Product B, 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), followed by an ad-libitum, 4-hour product use session on the same day.
Product C, 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), followed by an ad-libitum, 4-hour product use session on the same day.
Product D, 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), followed by an ad-libitum, 4-hour product use session on the same day.
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), followed by an ad-libitum, 4-hour product use session on the same day.
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
- Female subjects of childbearing potential must use contraception
- Male subjects 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 body mass index (BMI) \> 30.0 kg/m\^2 or \< 18.0 kg/m\^2 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, United Kingdom
Results Point of Contact
- Title
- Tasnim Abusalem
- 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
October 10, 2023
First Posted
October 23, 2023
Study Start
July 7, 2023
Primary Completion
November 3, 2023
Study Completion
November 3, 2023
Last Updated
February 3, 2025
Results First Posted
February 3, 2025
Record last verified: 2025-01