N/A
N=31
Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
Smoking · Nicotine
Bottom Line
View on ClinicalTrials.gov: NCT05317195 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Background-corrected Maximum Plasma Concentration [Cmax] — 8.109; 11.48; 2.629; 3.464 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NP-1 (Other); NP-2 (Other); NP-3 (Other); NP-4 (Other); Velo-NP (Other); Zyn-NP (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Background-corrected Maximum Plasma Concentration [Cmax] |
8.109; 11.48; 2.629; 3.464; 11.32; 9.257 | — |
| PRIMARY Background-corrected Time to the Maximum Concentration [Tmax] |
35.70; 34.80; 34.89; 34.98; 33.99; 34.95 | — |
| PRIMARY Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity) |
128.2; 217.3; 41.35; 49.30; 201.3; 136.0 | — |
| SECONDARY Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment |
61.0; 62.6; 64.3; 67.4; 68.6; 68.9 | — |
| SECONDARY Score of "in the Moment" Product Liking by the VAS-liking Assessment |
49.7; 55.8; 50.1; 48.2; 51.7; 60.2 | — |
| SECONDARY Score of Overall Product Liking by the VAS-liking Assessment |
56.5; 53.2; 49.0; 49.5; 49.9; 52.3 | — |
| SECONDARY Score of Product Satisfaction by the VAS-satisfaction Assessment |
52.5; 51.5; 45.8; 50.2; 48.4; 55.8 | — |
| SECONDARY Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment |
51.3; 52.0; 46.7; 48.3; 55.3; 57.9 | — |
Summary
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).
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT05317195). 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.