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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05459857
• Other study ID #: NER01/0004
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2022
• Source: Imperial Brands PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Celerion	Belfast	Nothern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
Imperial Brands PLC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nicotine Cmax	Maximum measured plasma nicotine concentration	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
Primary	Nicotine AUCt	The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration	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	Smoking urges Emax	The maximum change from baseline Visual Analog Scale (VAS) score (VASpre-use - VASpost-use). Subjects answer the question "How strong is your urge to smoke right now?" on a VAS: from Not at all on the left (0%) to Extreme on the right (100%).	10 minutes prior to the start of the product use session, and at 4, 8, 15, 45, 60, 210 and 240 following the start of study product use minutes