Smoking Clinical Trial
Official title:
A Single-center, Randomized, Controlled, Open-label Study to Investigate the Nicotine Pharmacokinetic Profiles and Subjective Effects of Four Variants of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
Verified date | August 2022 |
Source | Philip Morris Products S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition, pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch 1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6 sequences in a Williams design (cross-over).
Status | Completed |
Enrollment | 24 |
Est. completion date | August 18, 2022 |
Est. primary completion date | May 7, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Main Inclusion Criteria: - Subject has smoked continuously for at least the last 3 years prior to the Screening visit. - Subject has smoked = 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission. Smoking status will be verified based on a urinary cotinine test (cotinine = 500 ng/mL). - Subject does not plan to quit using tobacco and/or nicotine products within the next 3 months. - Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period. Main Exclusion Criteria: - As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical. - Subject is legally incompetent, or physically or mentally incapable of giving consent. - Subject has a clinically relevant disease that requires medication, which as per the judgment of the Investigator would jeopardize the safety of the subject. - Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit. - Subject has a BMI < 18.5 kg/m2 or > 32.0 kg/m2 (Europe) or > 35.0 kg/m2 (USA). - For women only: subject is pregnant (does not have negative pregnancy test at Screening Visit and at Admission) or is breastfeeding. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Celerion | Belfast | Northern Ireland |
Lead Sponsor | Collaborator |
---|---|
Philip Morris Products S.A. |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Background-corrected maximum plasma concentration [Cmax] | To measure the background-corrected maximum plasma concentration [Cmax] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period. | Measured at baseline (day 1), day 2, and day 3 | |
Primary | Background-corrected time to the maximum concentration [Tmax] | To measure the background-corrected time to the maximum concentration [Tmax] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period. | Measured at baseline (day 1), day 2, and day 3 | |
Primary | Area under the background-corrected concentration-time curve (AUC) from start of product use | To measure the area under the background-corrected concentration-time curve (AUC) from start of product use of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period. | Measured at baseline (day 1), day 2, and day 3 | |
Secondary | Score of cigarette craving by the visual analog sale (VAS)-craving assessment | To measure cigarette craving by the visual analog sale (VAS)-craving assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. | Measured at baseline (day 1), day 2, and day 3 | |
Secondary | Score of "in the moment" product liking by the VAS-liking assessment | To measure "in the moment" product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. | Measured at baseline (day 1), day 2, and day 3 | |
Secondary | Score of overall product liking by the VAS-liking assessment | To measure overall product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. | Measured at baseline (day 1), day 2, and day 3 | |
Secondary | Score of product satisfaction by the VAS-satisfaction assessment | To measure product satisfaction by the VAS-satisfaction assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. | Measured at baseline (day 1), day 2, and day 3 | |
Secondary | Score of product intention to use again by the VAS-intention to use again assessment | To measure intention to use product again by the VAS-intention to use again assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. | Measured at baseline (day 1), day 2, and day 3 |
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