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CompletedNCT02532374Updated Feb 24, 2020Results posted

Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L

An interventional study of Nicorette® inhalator and P3L in Smoking, sponsored by Philip Morris Products S.A.. Completed at 1 site in New Zealand. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-24.

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

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Smoking

Keywords

  • nicotine absorption
  • nicotine containing product
  • adult smoker
  • Nicorette
  • nicotine delivery system
03

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.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Nicorette® inhalator then P3L

    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.

    Other: Nicorette® inhalator · Other: P3L

Interventions

  • OtherNicorette® inhalator

    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).

  • OtherP3L

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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).

    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.

  6. 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).

    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.

  7. 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).

    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.

  8. 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).

    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.

  9. 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.

    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.

  10. 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.

    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.

  11. 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.

    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.

  12. 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.

    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.

  13. 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.

    Time frame: Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.

  14. 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.

    Time frame: Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.

  15. 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.

    Time frame: Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.

  16. 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.

    Time frame: Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.

07

Results

Posted Jun 15, 2017

Participant flow

Study initiated (1st subject screened): 07 October 2015 At admission, all the subjects were to try the P3L (50 μg/puff) and Nicorette® inhalator. Smoking or use of any tobacco/nicotine-containing products or electronic cigarettes, apart from product use assigned on the assessment days, was not allowed during the visits on site.

Participant flow — Overall Study
MilestoneNicorette® Inhalator Then P3L
Started16
Nicorette inhalator (visit 3)15
P3l 50 μg/puff (visit 4)15
P3l 80 μg/puff (visit 5)14
P3l150 μg/puff (visit 6)14
Completed14
Not completed2
Withdrew: Withdrawal by subject1
Withdrew: Physician decision1

Outcome measures

PrimaryMaximum 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.

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.
Reported as:
Least squares mean · ng/mL
Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator
ng/mLNicorette® Inhalator
Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator6.095 (4.243 to 8.755)
PrimaryMaximum 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.

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.
Reported as:
Least squares mean · ng/mL
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff
ng/mLP3L 50 µg/Puff
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff9.659 (6.724 to 13.874)
PrimaryMaximum 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.

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.
Reported as:
Least squares mean · ng/mL
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff
ng/mLP3L 80 µg/Puff
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff11.145 (7.701 to 16.128)
PrimaryMaximum 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.

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.
Reported as:
Least squares mean · ng/mL
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff
ng/mLP3L 150 µg/Puff
Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff9.805 (6.775 to 14.189)
PrimaryTime 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).

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.
Reported as:
Median · minutes
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator
minutesNicorette® Inhalator
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator30.0 (20.0 to 40.0)
PrimaryTime 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).

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.
Reported as:
Median · minutes
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff
minutesP3L 50 µg/Puff
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff7.0 (4.0 to 7.0)
PrimaryTime 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).

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.
Reported as:
Median · minutes
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff
minutesP3L 80 µg/Puff
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff7.0 (7.0 to 7.0)
PrimaryTime 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).

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.
Reported as:
Median · minutes
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff
minutesP3L 150 µg/Puff
Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff7.0 (4.0 to 7.0)
PrimaryArea 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.

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.
Reported as:
Least squares mean · h*ng/mL
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
h*ng/mLNicorette® Inhalator
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® Inhalator12.323 (9.251 to 16.415)
PrimaryArea 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.

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.
Reported as:
Least squares mean · h*ng/mL
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
h*ng/mLP3L 50 µg/Puff
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/Puff9.943 (7.465 to 13.245)
PrimaryArea 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.

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.
Reported as:
Least squares mean · h*ng/mL
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
h*ng/mLP3L 80 µg/Puff
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/Puff10.259 (7.644 to 13.770)
PrimaryArea 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.

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.
Reported as:
Least squares mean · h*ng/mL
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
h*ng/mLP3L 150 µg/Puff
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/Puff9.983 (7.438 to 13.399)
PrimaryArea 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.

Time frame:
Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Reported as:
Least squares mean · h*ng/mL
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
h*ng/mLNicorette® Inhalator
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® Inhalator0.124 (0.077 to 0.200)
PrimaryArea 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.

Time frame:
Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Reported as:
Least squares mean · h*ng/mL
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
h*ng/mLP3L 50 µg/Puff
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/Puff1.028 (0.640 to 1.650)
PrimaryArea 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.

Time frame:
Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Reported as:
Least squares mean · h*ng/mL
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
h*ng/mLP3L 80 µg/Puff
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/Puff1.157 (0.714 to 1.874)
PrimaryArea 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.

Time frame:
Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Reported as:
Least squares mean · h*ng/mL
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
h*ng/mLP3L 150 µg/Puff
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/Puff1.040 (0.642 to 1.684)

Adverse events

Collected over 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. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enrolment Period—0/16 (0%)7/16 (43.8%)
Nicorette® Inhalator Period—0/15 (0%)3/15 (20%)
P3L 50 µg/Puff Period—0/15 (0%)4/15 (26.7%)
P3L 80 µg/Puff Period—0/14 (0%)4/14 (28.6%)
P3L 150 µg/Puff Period—0/14 (0%)8/14 (57.1%)
Safety Follow-up Period—0/16 (0%)2/16 (12.5%)
Most frequent other events
Showing 10 of 16
Most frequent other events
EventEnrolment PeriodNicorette® Inhalator PeriodP3L 50 µg/Puff PeriodP3L 80 µg/Puff PeriodP3L 150 µg/Puff PeriodSafety Follow-up Period
Blood Albumin DecreasedInvestigations0/160/150/150/144/140/16
DizzinessNervous system disorders0/161/153/153/144/140/16
Blood Glucose DecreasedInvestigations0/160/150/150/142/140/16
HeadacheNervous system disorders0/162/150/150/140/140/16
Blood Triglycerides IncreasedInvestigations2/160/150/150/141/141/16
Blood Glucose IncreasedInvestigations2/160/150/150/140/140/16
Blood Bilirubin IncreasedInvestigations0/160/150/150/141/140/16
Blood Creatinine IncreasedInvestigations0/160/150/150/141/140/16
SyncopeNervous system disorders0/160/150/151/140/140/16
NauseaGastrointestinal disorders0/160/150/150/141/141/16

Baseline characteristics

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. No subjects were excluded due to major protocol deviations impacting the evaluation of the results. 1 subject withdrew after the product test at the admission visit.

Age, Continuous
Age, Continuous(years)Nicorette® Inhalator Then P3L
Mean39.8 ± 13.83
Sex: Female, Male
Sex: Female, Male(Participants)Nicorette® Inhalator Then P3L
Female7
Male8
Daily CC consumption at Screening
Daily CC consumption at Screening(Participants)Nicorette® Inhalator Then P3L
10 to 19 cig/day9
> 19 cig/day6
08

Study locations

1 site
  • Christchurch Clinical Studies Trust Ltd (CCST)
    Christchurch, 8011, New Zealand
09

References and documents

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 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02532374
Lead sponsor
Philip Morris Products S.A.
Responsible party
Sponsor
First posted
Aug 25, 2015
Start date
Oct 2015
Primary completion
Oct 2015
Completion
Feb 2016
Results posted
Jun 15, 2017
Last update
Feb 24, 2020

Study contacts

Christelle Haziza, PhD
study chair · Philip Morris Products S.A.
Chris Wynne, MD
principal investigator · Christchurch Clinical Studies Trust Ltd (CCST)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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