Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products

Imperial Brands

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D); Other: Heated tobacco product with heated tobacco sticks (Product B); Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C); Other: Heated tobacco product with heated tobacco sticks (Product A); Other: Conventional Cigarette (Product E)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06093659

NER 01/005

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 5 patient groups

Product use sequence ABECD

Experimental group

Description:

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.

Treatment:

Other: Conventional Cigarette (Product E)

Other: Heated tobacco product with heated tobacco sticks (Product A)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)

Other: Heated tobacco product with heated tobacco sticks (Product B)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)

Product use sequence BCADE

Experimental group

Description:

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.

Treatment:

Other: Conventional Cigarette (Product E)

Other: Heated tobacco product with heated tobacco sticks (Product A)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)

Other: Heated tobacco product with heated tobacco sticks (Product B)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)

Product use sequence CDBEA

Experimental group

Description:

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.

Treatment:

Other: Conventional Cigarette (Product E)

Other: Heated tobacco product with heated tobacco sticks (Product A)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)

Other: Heated tobacco product with heated tobacco sticks (Product B)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)

Product use sequence DECAB

Experimental group

Description:

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.

Treatment:

Other: Conventional Cigarette (Product E)

Other: Heated tobacco product with heated tobacco sticks (Product A)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)

Other: Heated tobacco product with heated tobacco sticks (Product B)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)

Product use sequence EADBC

Experimental group

Description:

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.

Treatment:

Other: Conventional Cigarette (Product E)

Other: Heated tobacco product with heated tobacco sticks (Product A)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product C)

Other: Heated tobacco product with heated tobacco sticks (Product B)

Other: Heated herbal product with nicotine-infused heated herbal sticks (Product D)