Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093659
• Other study ID #: NER 01/005
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Imperial Brands PLC
• Contact: Alvaro-Flavio Marinas Lacasta
• Phone: +44 117 3322447
• Email: alvaro-flavio.marinaslacasta[@]uk.imptob.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• 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
• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Pulze device with heated tobacco sticks (Product A)
Product A, 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), followed by an ad-libitum, 4-hour product use session on the same day.
• Pulze device with heated tobacco sticks (Product B)
Product B, 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), followed by an ad-libitum, 4-hour product use session on the same day.
• Pulze device with nicotine-infused heated herbal sticks (Product C)
Product C, 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), followed by an ad-libitum, 4-hour product use session on the same day.
• Pulze device with nicotine-infused heated herbal sticks (Product D)
Product D, 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), followed by an ad-libitum, 4-hour product use session on the same day.
• Conventional Cigarette (Product E)
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), followed by an ad-libitum, 4-hour product use session on the same day.

Locations

Country	Name	City	State
United Kingdom	Celerion	Belfast

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, for the controlled product use session	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, for the controlled product use session	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 "Right now, how much would you like to smoke a cigarette?" on a VAS: from Not at all on the left (0%) to A great deal on the right (100%), for the controlled product use session.	10 minutes prior to the start of the product use session, and at 4, 8, 15, 45, 60, 120 and 240 following the start of study product use minutes
Secondary	Puff count	Number of puffs taken during 2 hours of the 4-hour ad-libitum product use session	2 hours