Status:
COMPLETED
Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products
Lead Sponsor:
Imperial Brands PLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief 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 toba...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06093659
Start Date
July 7 2023
End Date
November 3 2023
Last Update
February 3 2025
Active Locations (1)
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1
Celerion
Belfast, United Kingdom