Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers

Not Applicable

Completed

• Conditions: Nicotine; Smoking
• Interventions: Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP

• Registration Number: NCT05317195
• Lead Sponsor: Philip Morris Products S.A.

Brief 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).

Detailed Description

The purpose of the study is to evaluate the nicotine PK profiles of 4 variants of NP 1.0 versus Velo-NP and Zyn-NP following a 30-minute use period. In addition, PD, including subjective effects and related behavioral assessments will be evaluated, to provide further insights on NP 1.0 product acceptance and abuse liability. Safety will be assessed throughout the study.

The aim is to evaluate if NP 1.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for smokers who would otherwise continue smoking cigarettes.

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Primary Completion: 2022-05-07
• Status Verified: 2022-08
• Study Completion: 2022-08-18
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NP-3	NP-2	Nicotine Pouch 1.0 (variant NP-3)
NP-3	Velo-NP	Nicotine Pouch 1.0 (variant NP-3)
Zyn-NP	NP-2	Zyn® Cool Mint Mini Dry
Zyn-NP	Velo-NP	Zyn® Cool Mint Mini Dry
NP-1	NP-1	Nicotine Pouch 1.0 (variant NP-1)
NP-1	NP-3	Nicotine Pouch 1.0 (variant NP-1)
NP-1	Velo-NP	Nicotine Pouch 1.0 (variant NP-1)
Velo-NP	NP-1	Velo® Ice Cool
NP-3	NP-3	Nicotine Pouch 1.0 (variant NP-3)
NP-1	NP-4	Nicotine Pouch 1.0 (variant NP-1)
NP-1	Zyn-NP	Nicotine Pouch 1.0 (variant NP-1)
NP-2	NP-2	Nicotine Pouch 1.0 (variant NP-2)
NP-2	Zyn-NP	Nicotine Pouch 1.0 (variant NP-2)
Velo-NP	Zyn-NP	Velo® Ice Cool
Zyn-NP	NP-1	Zyn® Cool Mint Mini Dry
Zyn-NP	NP-4	Zyn® Cool Mint Mini Dry
NP-1	NP-2	Nicotine Pouch 1.0 (variant NP-1)
NP-2	NP-1	Nicotine Pouch 1.0 (variant NP-2)
NP-2	Velo-NP	Nicotine Pouch 1.0 (variant NP-2)
NP-3	NP-4	Nicotine Pouch 1.0 (variant NP-3)
NP-4	NP-1	Nicotine Pouch 1.0 (variant NP-4)
NP-2	NP-3	Nicotine Pouch 1.0 (variant NP-2)
NP-2	NP-4	Nicotine Pouch 1.0 (variant NP-2)
NP-4	NP-2	Nicotine Pouch 1.0 (variant NP-4)
NP-4	Velo-NP	Nicotine Pouch 1.0 (variant NP-4)
Velo-NP	NP-3	Velo® Ice Cool
Velo-NP	Velo-NP	Velo® Ice Cool
NP-3	NP-1	Nicotine Pouch 1.0 (variant NP-3)
NP-3	Zyn-NP	Nicotine Pouch 1.0 (variant NP-3)
NP-4	Zyn-NP	Nicotine Pouch 1.0 (variant NP-4)
Velo-NP	NP-4	Velo® Ice Cool
Zyn-NP	NP-3	Zyn® Cool Mint Mini Dry
NP-4	NP-3	Nicotine Pouch 1.0 (variant NP-4)
NP-4	NP-4	Nicotine Pouch 1.0 (variant NP-4)
Velo-NP	NP-2	Velo® Ice Cool
Zyn-NP	Zyn-NP	Zyn® Cool Mint Mini Dry

Primary Outcome Measures

Name	Time	Method
Background-corrected Maximum Plasma Concentration [Cmax]	T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).	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.
Background-corrected Time to the Maximum Concentration [Tmax]	T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).	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.
Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)	T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).	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.

Secondary Outcome Measures

Name	Time	Method
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving Assessment	Measured before, and up to 6 hours post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)	To measure cigarette craving by the visual analog scale (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. Craving was assessed at selected time points on a scale from "no craving" (0 mm) to "strong craving" (100 mm) by measuring the number of millimeters (0-100 mm) from the "no craving" point to the point at which the drawn line intersected the scale.
Score of "in the Moment" Product Liking by the VAS-liking Assessment	Measured up to 1 hour post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)	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. Product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.
Score of Overall Product Liking by the VAS-liking Assessment	Measured after 30 minutes product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)	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. Overall product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.
Score of Product Satisfaction by the VAS-satisfaction Assessment	Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)	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. Product satisfaction was was assessed at selected time points on a scale from "not at all" (0 mm) to "extremely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "not at all" point to the point at which the drawn line intersected the scale.
Score of Product Intention to Use Again by the VAS-intention to Use Again Assessment	Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)	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. Intention to use again was was assessed at selected time points on a scale from "very unlikely" (0 mm) to "very likely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "very unlikely" point to the point at which the drawn line intersected the scale.

Trial Locations

Locations (1)

Celerion; 🇬🇧 Belfast, Northern Ireland, United Kingdom