N/A
Completed N=25
Nicotine Pharmacokinetic Study of Heated Tobacco and Heated Herbal Products
Healthy Volunteers
Source: ClinicalTrials.gov NCT06093659 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Nicotine Cmax — 13.00; 12.97; 6.00; 6.87 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nicotine Cmax |
13.00; 12.97; 6.00; 6.87; 18.51 | — |
| PRIMARY Nicotine AUCt |
716.3; 777.0; 363.9; 382.5; 1144.0 | — |
| SECONDARY Urge to Smoke Pre-use |
93.6; 94.0; 92.9; 91.9; 90.0 | — |
| SECONDARY Urge to Smoke Post-use |
91.4; 90.7; 88.7; 88.3; 87.6 | — |
| SECONDARY Urge to Smoke Emax |
56.0; 64.4; 43.0; 44.3; 69.2 | — |
| SECONDARY Puff Count |
30.3; 22.4; 32.4; 31.9; 20.2 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT06093659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.