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

Not Applicable

Completed

Conditions: Healthy Volunteers

Interventions: Other: Heated tobacco device Intense (Product A)
Other: Heated tobacco device Regular (Product B)
Other: Heated tobacco device Menthol (Product C)
Other: Combustible cigarette (Product D)

Registration Number: NCT05459857

Lead Sponsor: Imperial Brands PLC

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Product sequence ABCD	Combustible cigarette (Product D)	Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4
Product sequence ABCD	Heated tobacco device Intense (Product A)	Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4
Product sequence ABCD	Heated tobacco device Menthol (Product C)	Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4
Product sequence CADB	Heated tobacco device Regular (Product B)	Subjects 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	Heated tobacco device Regular (Product B)	Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4
Product sequence DCBA	Heated tobacco device Menthol (Product C)	Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4
Product sequence DCBA	Combustible cigarette (Product D)	Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4
Product sequence ABCD	Heated tobacco device Regular (Product B)	Subjects 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	Heated tobacco device Intense (Product A)	Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4
Product sequence BDAC	Heated tobacco device Regular (Product B)	Subjects use Product B on Day 1, Product D on Day 2, Product A on Day 3 and Product C on Day 4
Product sequence BDAC	Combustible cigarette (Product D)	Subjects 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	Heated tobacco device Menthol (Product C)	Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4
Product sequence BDAC	Heated tobacco device Menthol (Product C)	Subjects 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	Heated tobacco device Intense (Product A)	Subjects use Product C on Day 1, Product A on Day 2, Product D on Day 3 and Product B on Day 4
Product sequence CADB	Combustible cigarette (Product D)	Subjects 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	Heated tobacco device Intense (Product A)	Subjects use Product D on Day 1, Product C on Day 2, Product B on Day 3 and Product A on Day 4

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, baseline-adjusted
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, baseline-adjusted

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: "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'extreme'.
Urge to Smoke Post-Use	At 240 min following the start of study product use	The subjects self-assess their urge to smoke by answering the question: "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'extreme'.
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	The subjects self-assess their urge to smoke at defined time points by answering the question: "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale (VAS), with scores of 0 to 100, with 0 being 'not at all' and 100 being 'extreme'. Emax is calculated as the maximum absolute value of change from baseline (i.e., the maximum response) in VAS scores.