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

NCT05317195 | Completed Results

• 1 other identifier: P5-PK-01-EXP
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking; Nicotine

Keywords

Nicotine-containing products; Nicotine delivery

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

• 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.

  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).

• Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)

  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.

  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).

Secondary Outcomes (5)

• 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)

• 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)

• 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)

• Score of Product Satisfaction by the VAS-satisfaction Assessment

  Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)

• 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)

Study Arms (6)

NP-1

EXPERIMENTAL

Nicotine Pouch 1.0 (variant NP-1)

Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP

NP-2

EXPERIMENTAL

Nicotine Pouch 1.0 (variant NP-2)

Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP

NP-3

EXPERIMENTAL

Nicotine Pouch 1.0 (variant NP-3)

Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP

NP-4

EXPERIMENTAL

Nicotine Pouch 1.0 (variant NP-4)

Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP

Velo-NP

ACTIVE COMPARATOR

Velo® Ice Cool

Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP

Zyn-NP

ACTIVE COMPARATOR

Zyn® Cool Mint Mini Dry

Other: NP-1; Other: NP-2; Other: NP-3; Other: NP-4; Other: Velo-NP; Other: Zyn-NP

Interventions

NP-1 OTHER

NP-1; 8.4 mg nicotine; pH 8.0; moisture 30

NP-1; NP-2; NP-3; NP-4; Velo-NP; Zyn-NP

NP-2 OTHER

NP-2; 8.4 mg nicotine; pH 9.0; moisture 30

NP-1; NP-2; NP-3; NP-4; Velo-NP; Zyn-NP

NP-3 OTHER

NP-3; 3.6 mg nicotine; pH 8.0; moisture 15

NP-1; NP-2; NP-3; NP-4; Velo-NP; Zyn-NP

NP-4 OTHER

NP-4; 3.6 mg nicotine; pH 8.0; moisture 30

NP-1; NP-2; NP-3; NP-4; Velo-NP; Zyn-NP

Velo-NP OTHER

Velo-NP; 10 mg nicotine;

NP-1; NP-2; NP-3; NP-4; Velo-NP; Zyn-NP

Zyn-NP OTHER

Zyn-NP; 3 mg nicotine;

NP-1; NP-2; NP-3; NP-4; Velo-NP; Zyn-NP

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Celerion

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle Haziza, Global Head Clinical Research and Execution
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Rajkumar Chetty, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: March 15, 2022
• Primary Completion: May 7, 2022
• Study Completion: August 18, 2022
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-09

Locations

GB (1)