CompletedNCT06171490Updated Aug 13, 2024

Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of NP2, NP2-4mg and NP2-6mg, Compared to Nicotine Lozenge 4mg (Loz-4mg) and Nicotine Gum 4mg (Gum-4mg)

An interventional study of NP2-4mg and NP2-6 mg in Tobacco Use, sponsored by Philip Morris Products S.A.. Completed at 2 sites in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Philip Morris Products S.A. · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 56
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This is a multi-center, randomized, controlled, partially blinded study to assess the pharmacokinetics and comparative bioavailability of nicotine from two variants of NP2 (4 and 6 mg) in comparison with Loz-4mg and Gum-4mg in adult cigarette smokers. The subjects will be blinded to the randomized sequence and will be blinded to the variants of NP2 they will receive. The study will be conducted with 4 periods and 4 sequences in a Williams design (crossover).

Conditions studied

Tobacco Use

Keywords

Nicotine
Nicotine-containing products
Tobacco
Pharmacokinetics

In context

Lead sponsor

Philip Morris Products S.A. is the lead sponsor of 46 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subject has signed the ICF and is able to understand the information provided in the ICF.
Subject has smoked on a daily basis for at least the last 18 months prior to the Screening visit.
Subject has smoked on average ≥10 commercially available regular CIG/day over the last 4 weeks. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history).

Exclusion criteria

Exclusion Criteria:

Subject has reasons other than medical (e.g., psychological, social reason) not to be part of the study, as determined by the Investigator.
Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners).
Subject has a clinically relevant disease which requires medication or any other medical condition including abnormal spirometry, safety laboratory, as determined by the Investigator.
Subject presents difficulty with venipuncture and/or poor venous access.
Subject has an oromucosal or dental condition, which may affect the use of the investigational products, as determined by the Investigator or subject has orthodontic braces and retention wire (could likely interfere with the gum dosing).
Subject has medical conditions which require, or will require during the study, a medical intervention (e.g., start of treatment, surgery, hospitalization).
Presence of fever (body temperature >37.5°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
Subject has a Hemoglobin level \< 11.0 g/dL for females and \< 12.0 g/dL for males at the Screening.
Subject uses medication or any substance that aids in smoking cessation.
Subject postponed the decision to quit using tobaccoor nicotine-containing products in order to participate in this study.
Subject previously attempted to quit using tobacco- or nicotine-containing products within 28 days prior to the first study product administration.
Subject has donated plasma within seven days prior to Screening or has donated or lost 450 mL or more of whole blood within 8 weeks prior to Screening for males, and in the 12 weeks prior to Screening for females.
Subject has a known sensitivity or allergy to any of the investigational products, or ingredients.
Subject has a positive serology test for HIV 1/2, Hepatitis B, Hepatitis C.
Subject has a history of alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
Subject has a positive urine drug test. Investigator will assess whether THC positive subjects are eligible for participation in the study.
Subject has a positive alcohol breath test.
Subject or one of their family members is a current or former employee of the tobacco industry.
Subject or one of their family members a is an employee of the investigational site or of any other parties involved in the study.
Subject has participated in another clinical study within 30 days prior to the Screening Visit or concomitantly participates in an investigational study involving no drug or device administration.
Subject has been previously screened or enrolled in this study (except alternate subjects).
For women only: subject is pregnant (does not have negative pregnancy tests at Screening Visit and at Admission) or is a lactating female.
For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 56 participants (actual)

Study arms

Active comparator
Product Sequence 1
From Day 1 to Day 4, after at least 23 hours of abstinence from any nicotine/tobacco containing products, subjects will use one of the four investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: NP2-4mg; NP2-6mg; Loz-4mg; Gum-4mg / NP2-6mg; Gum-4mg; NP2-4mg; Loz-4mg / Gum-4mg; Loz-4mg; NP2-6mg; NP2-4mg / Loz-4mg; NP2-4mg; Gum-4mg; NP2-6mg
Other: NP2-4mg · Other: NP2-6 mg · Other: Loz-4mg · Other: Gum-4mg
Active comparator
Product Sequence 2
From Day 1 to Day 4, after at least 23 hours of abstinence from any nicotine/tobacco containing products, subjects will use one of the four investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: NP2-4mg; NP2-6mg; Loz-4mg; Gum-4mg / NP2-6mg; Gum-4mg; NP2-4mg; Loz-4mg / Gum-4mg; Loz-4mg; NP2-6mg; NP2-4mg / Loz-4mg; NP2-4mg; Gum-4mg; NP2-6mg
Other: NP2-4mg · Other: NP2-6 mg · Other: Loz-4mg · Other: Gum-4mg
Active comparator
Product Sequence 3
From Day 1 to Day 4, after at least 23 hours of abstinence from any nicotine/tobacco containing products, subjects will use one of the four investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: NP2-4mg; NP2-6mg; Loz-4mg; Gum-4mg / NP2-6mg; Gum-4mg; NP2-4mg; Loz-4mg / Gum-4mg; Loz-4mg; NP2-6mg; NP2-4mg / Loz-4mg; NP2-4mg; Gum-4mg; NP2-6mg
Other: NP2-4mg · Other: NP2-6 mg · Other: Loz-4mg · Other: Gum-4mg
Active comparator
Product Sequence 4
From Day 1 to Day 4, after at least 23 hours of abstinence from any nicotine/tobacco containing products, subjects will use one of the four investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: NP2-4mg; NP2-6mg; Loz-4mg; Gum-4mg / NP2-6mg; Gum-4mg; NP2-4mg; Loz-4mg / Gum-4mg; Loz-4mg; NP2-6mg; NP2-4mg / Loz-4mg; NP2-4mg; Gum-4mg; NP2-6mg
Other: NP2-4mg · Other: NP2-6 mg · Other: Loz-4mg · Other: Gum-4mg

Interventions

OtherNP2-4mg
NP2-4 mg is a new product containing tobacco-derived nicotine.
OtherNP2-6 mg
NP2-6 mg is a new product containing tobacco-derived nicotine.
OtherLoz-4mg
The Loz-4mg reference product is a commercially available 4mg nicotine lozenge.
OtherGum-4mg
The Gum-4mg reference product is a commercially available 4mg nicotine gum.

What researchers measure

Primary outcomes

Maximum Plasma Concentration [Cmax]
To measure Cmax following use of the investigational products and reference products
Time frame: Measured from start of product use to 24 hours
Area under the observed concentration-time curve (AUC) from start of product use (T0) to timepoint of last quantifiable concentration [AUC0-last] and extrapolated to infinity [AUC0-infinity]
To measure the area under the background-corrected concentration-time curve (AUC) from start of product use
Time frame: Measured from start of product use (T0) to 2 minutes, to 4 minutes, to 10 hours, to time of last quantifiable concentration.
Ratio of [AUC0-last] and [AUC0-infinity]
To measure the ratio of \[AUC0-last\] and \[AUC0-infinity\]
Time frame: Measured from start of product use to 24 hours
Time to the observed maximum concentration [Tmax]
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)
Time frame: Measured from start of product use to 24 hours
Elimination rate constant [kel]
To measure the fraction of nicotine eliminated per unit of time, following use of the investigational products and reference products
Time frame: Measured from start of product use to 24 hours
Half-life of nicotine [t1/2]
To measure the half-life of nicotine, following use of the investigational products and reference products
Time frame: Measured from start of product use to 24 hours

Study locations

2 sites

Pharma Medica Research Inc.
Toronto, Ontario M1S 3V6, Canada
Syneos Health Clinique Inc.
Québec, G1P 0A2, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06171490
Lead sponsor: Philip Morris Products S.A.
Responsible party: Sponsor
First posted: Dec 14, 2023
Start date: Oct 20, 2023
Primary completion: Jan 14, 2024
Completion: Mar 20, 2024
Last update: Aug 13, 2024

Study contacts

Christelle Haziza, PhD

study chair · Philip Morris Products S.A.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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