N/A
N=24
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05459857 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Nicotine Cmax — 10.500; 7.539; 8.191; 21.680 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Product A (Other); Product B (Other); Product C (Other); Product D (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Imperial Brands PLC
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nicotine Cmax |
10.500; 7.539; 8.191; 21.680 | — |
| PRIMARY Nicotine AUCt |
746.00; 586.50; 585.00; 1514.00 | — |
| SECONDARY Urge to Smoke Pre-Use |
63.8; 57.8; 64.2; 62.8 | — |
| SECONDARY Urge to Smoke Post-Use |
61.4; 67.5; 71.3; 67.5 | — |
| SECONDARY Smoking Urges Emax |
40.30; 32.90; 39.70; 49.80 | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT05459857). 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.