SmokingNCT02532374

Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L

A study testing Nicorette® inhalator and P3L in people with Smoking, run by Philip Morris Products S.A. at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid (P3L) system at three different nicotine levels in smoking healthy subjects in relation to… Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking
What is being tested?: Nicorette® inhalator and P3L
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteNew Zealand
Study dates: Oct 2015to Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject is Caucasian
Smoking, healthy subject as judged by the Investigator
Subject smoked at least 10 commercially available non-menthol cigarettes (CCs) per day for the last 4 weeks
Subject has smoked for at least the last 3 years prior to screening
Subject does not plan to quit smoking in the next 3 months

Who cannot join

As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason)
Subject has donated or been in receipt of whole blood or blood products within 3 months prior to Admission Visit
Female subject is pregnant or breast feeding
Female subject does not agree to use an acceptable method of effective contraception
Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

Christchurch Clinical Studies Trust Ltd (CCST)
Christchurch, 8011

Other trials in New Zealand

About this study

Official title: A Single-center, Open-label, Ascending Nicotine Levels Study to Investigate the Nicotine Pharmacokinetic and Pharmacodynamics Profiles, Safety and Tolerability of P3L in Smoking Healthy Subjects in Relation to Nicorette® Inhalator

Read the detailed description

The entire study will last between 16 to 49 days per subject. This includes :

a screening period of up to 4 weeks prior to admission,
1 day of admission (Visit 2): after all inclusion/exclusion criteria are checked, all eligible subjects will be enrolled and perform a product test, first with P3L (at nicotine dose levels of approximately 50 μg/puff) and subsequently with Nicorette® inhalator (3 to 5 inhalations for each product).
4 days of on-site product use (one day with Nicorette® inhalator [Visit 3] and three days with P3L [Visit 4, Visit 5 and Visit 6]),
1 to 3 days between each product use and
a 7-day safety follow-up period (discharge + 7 days), during which there are no scheduled investigational visits, and during which adverse events (AEs) and serious adverse events (SAEs) can be spontaneously reported by the subjects and the follow-up of AEs/SAEs will be conducted by the study investigational site.

Subjects will come to the investigational site the night before each assessment day, at least 12 hours prior to the product use, on Visit 4, Visit 5, and Visit 6. Subjects will stay overnight at the investigational site between the admission visit (Visit 2) and Visit 3. Smoking or use of any tobacco/nicotine-containing products or electronic cigarettes, apart from product use assigned on the assessment days, will not be allowed during their stay at the investigational site. Smoking will be allowed once the subjects have left the investigational site.

The maximum concentration of nicotine (Cmax) and the area under the concentration-time curve from start of product use to the last quantifiable time point (AUC0-last) will be derived from multiple blood sampling pre- and post-product use, and corrected for baseline nicotine concentration.

Conditions: Smoking
Being tested: Nicorette® inhalator, P3L
Keywords: nicotine absorption, nicotine containing product, adult smoker, Nicorette, nicotine delivery system
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nicorette® inhalatorOther
Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
P3LOther
Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).

Study groups in NCT02532374
Study group	Role	What they receive
Nicorette® inhalator then P3L	Experimental	Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively. Receives: Other: Nicorette® inhalator; Other: P3L

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Measured: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Measured: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Measured: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Measured: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff
T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Geometric Least Squares (geometric LS) means are provided.
Measured: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Feb 2016

First posted25 Aug 2015 (estimated)
Study startOct 2015
Primary completionOct 2015
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02532374
Sponsor's protocol ID: P3L-PK-01-NZ
Other IDs: P3L-PK-01-NZ
Status last verified: Feb 2020
First submitted: 21 Aug 2015
Last updated: 24 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Teichert A, Brossard P, Felber Medlin L, Sandalic L, Franzon M, Wynne C, Laugesen M, Ludicke F. Evaluation of Nicotine Pharmacokinetics and Subjective Effects following Use of a Novel Nicotine Delivery System. Nicotine Tob Res. 2018 Mar 6;20(4):458-465. doi: 10.1093/ntr/ntx093.
PubMed 28482017

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, Ascending Nicotine Levels Study to Investigate the Nicotine Pharmacokinetic and Pharmacodynamics Profiles, Safety and Tolerability of P3L in Smoking Healthy Subjects in Relation to Nicorette® Inhalator
ClinicalTrials.gov ID: NCT02532374
Acronym / sponsor ID: P3L-PK-01-NZ
Conditions: Smoking
Keywords: nicotine absorption, nicotine containing product, adult smoker, Nicorette, nicotine delivery system
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Oct 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 25 Aug 2015 (estimated)
Results: Posted 15 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The entire study will last between 16 to 49 days per subject. This includes :

a screening period of up to 4 weeks prior to admission,
1 day of admission (Visit 2): after all inclusion/exclusion criteria are checked, all eligible subjects will be enrolled and perform a product test, first with P3L (at nicotine dose levels of approximately 50 μg/puff) and subsequently with Nicorette® inhalator (3 to 5 inhalations for each product).
4 days of on-site product use (one day with Nicorette® inhalator [Visit 3] and three days with P3L [Visit 4, Visit 5 and Visit 6]),
1 to 3 days between each product use and
a 7-day safety follow-up period (discharge + 7 days), during which there are no scheduled investigational visits, and during which adverse events (AEs) and serious adverse events (SAEs) can be spontaneously reported by the subjects and the follow-up of AEs/SAEs will be conducted by the study investigational site.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nicorette® inhalator then P3L	Experimental	Other: Nicorette® inhalator, Other: P3LEach subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject is Caucasian
Smoking, healthy subject as judged by the Investigator
Subject smoked at least 10 commercially available non-menthol cigarettes (CCs) per day for the last 4 weeks
Subject has smoked for at least the last 3 years prior to screening
Subject does not plan to quit smoking in the next 3 months

Key exclusion criteria (5 listed)

As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason)
Subject has donated or been in receipt of whole blood or blood products within 3 months prior to Admission Visit
Female subject is pregnant or breast feeding
Female subject does not agree to use an acceptable method of effective contraception
Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy

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
Nicorette® inhalatorSubjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).	Other	Nicorette® inhalator then P3L
P3LSubjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).	Other	Nicorette® inhalator then P3L

Primary outcome

Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator
Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff
Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff
Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff
Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator
Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff
Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff
Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff
Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator
Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff
Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff
Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff
Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator
Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff
Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff
Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff
Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
T0 = start of product use. Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use). Geometric Least Squares (geometric LS) means are provided.

Results and safety

Results posted to the registry on 15 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nicorette® Inhalator Then P3L	16	14

Primary outcome: Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator

Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.. Least squares mean (95% Confidence Interval). Unit: ng/mL

Measure	Nicorette® Inhalator n = 15
Value	6.095 (4.243 to 8.755)

Population analysed: PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived. =\> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects

Primary outcome: Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff

Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.. Least squares mean (95% Confidence Interval). Unit: ng/mL

Measure	P3L 50 µg/Puff n = 15
Value	9.659 (6.724 to 13.874)

Primary outcome: Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff

Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.. Least squares mean (95% Confidence Interval). Unit: ng/mL

Measure	P3L 80 µg/Puff n = 14
Value	11.145 (7.701 to 16.128)

Primary outcome: Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff

Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.. Least squares mean (95% Confidence Interval). Unit: ng/mL

Measure	P3L 150 µg/Puff n = 14
Value	9.805 (6.775 to 14.189)

Adverse events

Time frame: From the informed consent form (ICF) signature until the end of the safety follow-up period, up to 49 days (see the section "Detailed Description" for information on the study duration). The adverse events were tabulated for the safety population for: * Enrolment period (product test period, from enrolment to admission) * Nicorette® inhalator period * P3L 50 μg/puff period * P3L 80 μg/puff period * P3L 150 μg/puff period * Safety follow-up period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enrolment Period	0 of 16 (0%)	7 of 16 (43.8%)	Not reported
Nicorette® Inhalator Period	0 of 15 (0%)	3 of 15 (20%)	Not reported
P3L 50 µg/Puff Period	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
P3L 80 µg/Puff Period	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
P3L 150 µg/Puff Period	0 of 14 (0%)	8 of 14 (57.1%)	Not reported
Safety Follow-up Period	0 of 16 (0%)	2 of 16 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28482017Teichert A, Brossard P, Felber Medlin L, Sandalic L, Franzon M, Wynne C, Laugesen M, Ludicke F. Evaluation of Nicotine Pharmacokinetics and Subjective Effects following Use of a Novel Nicotine Delivery System. Nicotine Tob Res. 2018 Mar 6;20(4):458-465. doi: 10.1093/ntr/ntx093.
Individual participant dataSharing planned: No

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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.

Chris Wynne, MD principal investigator

Christchurch Clinical Studies Trust Ltd (CCST)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nicorette® inhalator and P3L in people with Smoking, run by Philip Morris Products S.A. at 1 site in New Zealand.

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 5 inclusion and 5 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. 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?

Yes. Results are posted in the registry (first posted 15 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator (time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02532374, which also lists 1 linked publication.

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 24 Feb 2020.