Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products

Last updated: January 6, 2025
Sponsor: Imperial Brands PLC
Overall Status: Completed

Phase

N/A

Condition

Healthy Volunteers

Treatment

Conventional Cigarette (Product E)

Pulze device with heated tobacco sticks (Product A)

Heated tobacco product with heated tobacco sticks (Product A)

Clinical Study ID

NCT06093659
NER 01/005
  • Ages 21-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Reports smoking an average of at least 10 manufactured combustible (menthol ornon-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

Exclusion Criteria:

  • Has a history or presence of clinically significant disease or condition that, inthe opinion of the Investigator, would jeopardise the safety of the subject orimpact the validity of the study results.

  • Has a positive test for human immunodeficiency virus (HIV), hepatitis B surfaceantigen (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 toCheck-in Is planning to quit smoking during the study or within the next 3 months

Study Design

Total Participants: 25
Treatment Group(s): 9
Primary Treatment: Conventional Cigarette (Product E)
Phase:
Study Start date:
July 07, 2023
Estimated Completion Date:
November 03, 2023

Connect with a study center

  • Celerion

    Belfast,
    United Kingdom

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.