A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes

Imperial Brands

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Product B; Other: Product D; Other: Product A; Other: Product C

Study type: Interventional

Funder types: Industry

Identifiers

NCT05459857

NER01/0004

Details and patient eligibility

About

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.

Enrollment: 24 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
• A female subject of childbearing potential must use contraception
• Male subject 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 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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24 participants in 4 patient groups

Product sequence ABCD

Experimental group

Description:

Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4

Treatment:

Other: Product C

Other: Product A

Other: Product D

Other: Product B

Product sequence BDAC

Experimental group

Description:

Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4

Treatment:

Other: Product C

Other: Product A

Other: Product D

Other: Product B

Product sequence CADB

Experimental group

Description:

Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4

Treatment:

Other: Product C

Other: Product A

Other: Product D

Other: Product B

Product sequence DCBA

Experimental group

Description:

Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4

Treatment:

Other: Product C

Other: Product A

Other: Product D

Other: Product B