Tobacco UseNCT06171490
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)
A study testing NP2-4mg, NP2-6 mg and Loz-4mg in people with Tobacco Use, run by Philip Morris Products S.A. at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- NP2-4mg, NP2-6 mg and Loz-4mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Oct 2023to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 23Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Syneos Health Clinique Inc.
Québec, G1P 0A2
Pharma Medica Research Inc.
Toronto, Ontario, M1S 3V6
About this study
Official title: A Multi-center, Randomized, Controlled, Partially Blinded Study to Assess the Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of Nicotine Pouch 2.0 (NP2), 4mg and 6mg, Compared to Nicotine Lozenge 4mg and Nicotine Gum 4mg in Adult Cigarette Smokers
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
- Tobacco Use
- Being tested
- NP2-4mg, NP2-6 mg, Loz-4mg, Gum-4mg
- Keywords
- Nicotine, Nicotine-containing products, Tobacco, Pharmacokinetics
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP2-4mgOther
NP2-4 mg is a new product containing tobacco-derived nicotine.
NP2-6 mgOther
NP2-6 mg is a new product containing tobacco-derived nicotine.
Loz-4mgOther
The Loz-4mg reference product is a commercially available 4mg nicotine lozenge.
Gum-4mgOther
The Gum-4mg reference product is a commercially available 4mg nicotine gum.
| Study group | Role | What they receive |
|---|---|---|
| Product Sequence 1 | Active comparator | 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 Receives: Other: NP2-4mg; Other: NP2-6 mg; Other: Loz-4mg; Other: Gum-4mg |
| Product Sequence 2 | Active comparator | 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 Receives: Other: NP2-4mg; Other: NP2-6 mg; Other: Loz-4mg; Other: Gum-4mg |
| Product Sequence 3 | Active comparator | 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 Receives: Other: NP2-4mg; Other: NP2-6 mg; Other: Loz-4mg; Other: Gum-4mg |
| Product Sequence 4 | Active comparator | 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 Receives: Other: NP2-4mg; Other: NP2-6 mg; Other: Loz-4mg; Other: Gum-4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [Cmax]
To measure Cmax following use of the investigational products and reference products
Measured: 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
Measured: 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]
Measured: 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)
Measured: 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
Measured: 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
Measured: Measured from start of product use to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start20 Oct 2023
- Primary completion14 Jan 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be conducted with 4 periods and 4 sequences in a Williams design (crossover).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christelle Haziza, PhD, Study chair, Philip Morris Products S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171490
- Sponsor's protocol ID
- PZ-PK-03-CAN
- Status last verified
- Aug 2024
- First submitted
- 6 Dec 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled, Partially Blinded Study to Assess the Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of Nicotine Pouch 2.0 (NP2), 4mg and 6mg, Compared to Nicotine Lozenge 4mg and Nicotine Gum 4mg in Adult Cigarette Smokers
- ClinicalTrials.gov ID
- NCT06171490
- Acronym / sponsor ID
- PZ-PK-03-CAN
- Conditions
- Tobacco Use
- Keywords
- Nicotine, Nicotine-containing products, Tobacco, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The study will be conducted with 4 periods and 4 sequences in a Williams design (crossover).
| Arm | Type | Receives |
|---|---|---|
| Product Sequence 1 | Active comparator | Other: NP2-4mg, Other: NP2-6 mg, Other: Loz-4mg, Other: Gum-4mgFrom 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 |
| Product Sequence 2 | Active comparator | Other: NP2-4mg, Other: NP2-6 mg, Other: Loz-4mg, Other: Gum-4mgFrom 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 |
| Product Sequence 3 | Active comparator | Other: NP2-4mg, Other: NP2-6 mg, Other: Loz-4mg, Other: Gum-4mgFrom 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 |
| Product Sequence 4 | Active comparator | Other: NP2-4mg, Other: NP2-6 mg, Other: Loz-4mg, Other: Gum-4mgFrom 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP2-4mgNP2-4 mg is a new product containing tobacco-derived nicotine. | Other | Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4 |
| NP2-6 mgNP2-6 mg is a new product containing tobacco-derived nicotine. | Other | Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4 |
| Loz-4mgThe Loz-4mg reference product is a commercially available 4mg nicotine lozenge. | Other | Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4 |
| Gum-4mgThe Gum-4mg reference product is a commercially available 4mg nicotine gum. | Other | Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4 |
Primary outcome
Maximum Plasma Concentration [Cmax]
Time frame: Measured from start of product use to 24 hours
To measure Cmax following use of the investigational products and reference products
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]
Time frame: Measured from start of product use (T0) to 2 minutes, to 4 minutes, to 10 hours, to time of last quantifiable concentration.
To measure the area under the background-corrected concentration-time curve (AUC) from start of product use
Ratio of [AUC0-last] and [AUC0-infinity]
Time frame: Measured from start of product use to 24 hours
To measure the ratio of [AUC0-last] and [AUC0-infinity]
Time to the observed maximum concentration [Tmax]
Time frame: Measured from start of product use to 24 hours
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)
Elimination rate constant [kel]
Time frame: Measured from start of product use to 24 hours
To measure the fraction of nicotine eliminated per unit of time, following use of the investigational products and reference products
Half-life of nicotine [t1/2]
Time frame: Measured from start of product use to 24 hours
To measure the half-life of nicotine, following use of the investigational products and reference products
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Haziza, PhD study chair
Philip Morris Products S.A.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NP2-4mg, NP2-6 mg and Loz-4mg in people with Tobacco Use, run by Philip Morris Products S.A. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration [Cmax] (time frame: Measured from start of product use to 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.