Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products

Not Applicable

Completed

Conditions: Healthy Volunteers

Interventions: Other: Pulze device with heated tobacco sticks (Product A)
Other: Pulze device with heated tobacco sticks (Product B)
Other: Pulze device with nicotine-infused heated herbal sticks (Product C)
Other: Pulze device with nicotine-infused heated herbal sticks (Product D)
Other: Conventional Cigarette (Product E)

Registration Number: NCT06093659

Lead Sponsor: Imperial Brands PLC

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Product use sequence BCADE	Pulze device with nicotine-infused heated herbal sticks (Product C)	Subjects 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 BCADE	Pulze device with heated tobacco sticks (Product A)	Subjects 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	Pulze device with nicotine-infused heated herbal sticks (Product C)	Subjects 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 CDBEA	Conventional Cigarette (Product E)	Subjects 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 EADBC	Conventional Cigarette (Product E)	Subjects 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.
Product use sequence ABECD	Pulze device with heated tobacco sticks (Product A)	Subjects 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 ABECD	Pulze device with nicotine-infused heated herbal sticks (Product D)	Subjects 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 CDBEA	Pulze device with heated tobacco sticks (Product A)	Subjects 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 ABECD	Pulze device with heated tobacco sticks (Product B)	Subjects 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 ABECD	Pulze device with nicotine-infused heated herbal sticks (Product C)	Subjects 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 ABECD	Conventional Cigarette (Product E)	Subjects 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	Pulze device with heated tobacco sticks (Product B)	Subjects 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 BCADE	Pulze device with nicotine-infused heated herbal sticks (Product D)	Subjects 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 BCADE	Conventional Cigarette (Product E)	Subjects 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	Pulze device with heated tobacco sticks (Product B)	Subjects 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 CDBEA	Pulze device with nicotine-infused heated herbal sticks (Product D)	Subjects 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	Pulze device with nicotine-infused heated herbal sticks (Product D)	Subjects 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	Pulze device with nicotine-infused heated herbal sticks (Product C)	Subjects 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.
Product use sequence DECAB	Pulze device with heated tobacco sticks (Product A)	Subjects 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 DECAB	Pulze device with nicotine-infused heated herbal sticks (Product C)	Subjects 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	Pulze device with heated tobacco sticks (Product A)	Subjects 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.
Product use sequence EADBC	Pulze device with heated tobacco sticks (Product B)	Subjects 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.
Product use sequence EADBC	Pulze device with nicotine-infused heated herbal sticks (Product D)	Subjects 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.
Product use sequence DECAB	Pulze device with heated tobacco sticks (Product B)	Subjects 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 DECAB	Conventional Cigarette (Product E)	Subjects 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.

Primary Outcome Measures

Name	Time	Method
Nicotine Cmax	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	Maximum measured plasma nicotine concentration, following the controlled product use session
Nicotine AUCt	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	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

Secondary Outcome Measures

Name	Time	Method
Urge to Smoke Pre-use	10 minutes prior to the start of the product use session	The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'.
Urge to Smoke Post-use	At 240 minutes following the start of study product use	The subjects self-assess their urge to smoke by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'a great deal'.
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.	The subjects self-assess their urge to smoke at defined time points by answering the question: "Right now, how much would you like to smoke a cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'A great deal'. Emax is calculated as the maximum absolute value of change from baseline (pre-use) (i.e., the maximum response) in VAS scores.
Puff Count	Hours 2-4 of the 4-hour ad libitum product use session	Number of puffs taken during last 2 hours of the 4-hour ad-libitum product use session