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

P

Philip Morris

Status

Completed

Conditions

Nicotine
Smoking

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05317195
P5-PK-01-EXP

Details and patient eligibility

About

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).

Full 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.

Enrollment

24 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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 < 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

24 participants in 6 patient groups

NP-1
Experimental group
Description:
Nicotine Pouch 1.0 (variant NP-1)
Treatment:
Other: NP-4
Other: Velo-NP
Other: NP-1
Other: NP-2
Other: Zyn-NP
Other: NP-3
NP-2
Experimental group
Description:
Nicotine Pouch 1.0 (variant NP-2)
Treatment:
Other: NP-4
Other: Velo-NP
Other: NP-1
Other: NP-2
Other: Zyn-NP
Other: NP-3
NP-3
Experimental group
Description:
Nicotine Pouch 1.0 (variant NP-3)
Treatment:
Other: NP-4
Other: Velo-NP
Other: NP-1
Other: NP-2
Other: Zyn-NP
Other: NP-3
NP-4
Experimental group
Description:
Nicotine Pouch 1.0 (variant NP-4)
Treatment:
Other: NP-4
Other: Velo-NP
Other: NP-1
Other: NP-2
Other: Zyn-NP
Other: NP-3
Velo-NP
Active Comparator group
Description:
Velo® Ice Cool
Treatment:
Other: NP-4
Other: Velo-NP
Other: NP-1
Other: NP-2
Other: Zyn-NP
Other: NP-3
Zyn-NP
Active Comparator group
Description:
Zyn® Cool Mint Mini Dry
Treatment:
Other: NP-4
Other: Velo-NP
Other: NP-1
Other: NP-2
Other: Zyn-NP
Other: NP-3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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