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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05317195
Other study ID # P5-PK-01-EXP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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