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 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05317195
• Other study ID #: P5-PK-01-EXP
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 18, 2022

Study information

• Verified date: August 2022
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Nicotine
• Smoking

Intervention

Other:
• NP-1
NP-1; 8.4 mg nicotine; pH 8.0; moisture 30
• NP-2
NP-2; 8.4 mg nicotine; pH 9.0; moisture 30
• NP-3
NP-3; 3.6 mg nicotine; pH 8.0; moisture 15
• NP-4
NP-4; 3.6 mg nicotine; pH 8.0; moisture 30
• Velo-NP
Velo-NP; 10 mg nicotine;
• Zyn-NP
Zyn-NP; 3 mg nicotine;

Locations

Country	Name	City	State
United Kingdom	Celerion	Belfast	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

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