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| ID | Type | Description | Link |
|---|---|---|---|
| P3L-PK-01-NZ | Other Identifier | Philip Morris Products S.A |
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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.
The entire study will last between 16 to 49 days per subject. This includes :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicorette® inhalator | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Chris Wynne, MD | Christchurch Clinical Studies Trust Ltd (CCST) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch Clinical Studies Trust Ltd (CCST) | Christchurch | 8011 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28482017 | Result | 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. |
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Enrolled population = 16 subjects
All enrolled subjects met all of the inclusion and none of the exclusion criteria for the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Nicorette® 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). P3L: 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Nicorette® 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). P3L: 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). |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | 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. |
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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
The safety was assessed in the safety population, consisting of all subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator.
Safety population = 16 subjects.
It should be noted that the assessment of clinical chemistry parameters occurred only at admission and Visit 6/early termination. Consequently, all safety laboratories occurring with product use where reported as pertaining to the last exposure period, i.e. P3L 150 μg/puff period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolment Period | All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator. Product test period - from enrolment to admission. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Albumin Decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Loyse Felber Medlin | Philip Morris Products S.A. | +41 (58) 242 2686 | Loyse.FelberMedlin@pmi.com |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| P3L | Other | 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). |
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T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).
| 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Daily CC consumption at Screening | Count of Participants | Participants |
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| Primary | 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | 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. |
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| Primary | 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. | 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 - 1 subject discontinued by the Principal Investigator = 14 subjects | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | 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. |
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| Primary | 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. | 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 - 1 subject discontinued by the Principal Investigator = 14 subjects | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | 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. |
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| Primary | 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). | 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 | Posted | Median | Inter-Quartile Range | minutes | 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. |
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| Primary | 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). | 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 | Posted | Median | Inter-Quartile Range | minutes | 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. |
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| Primary | 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). | 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 - 1 subject discontinued by the Principal Investigator = 14 subjects | Posted | Median | Inter-Quartile Range | minutes | 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. |
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| Primary | 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). | 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 - 1 subject discontinued by the Principal Investigator = 14 subjects | Posted | Median | Inter-Quartile Range | minutes | 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. |
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| Primary | 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | 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. |
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| Primary | 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | 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. |
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| Primary | 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. | 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 - 1 subject discontinued by the Principal Investigator = 14 subjects | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | 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. |
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| Primary | 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. | 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 - 1 subject discontinued by the Principal Investigator = 14 subjects | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | 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. |
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| Primary | 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. |
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| Primary | 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. | 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 | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. |
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| Primary | 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. | 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 - 1 subject discontinued by the Principal Investigator = 14 subjects | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. |
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| Primary | 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. | 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 - 1 subject discontinued by the Principal Investigator = 14 subjects | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0. |
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| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | Nicorette® Inhalator Period | Subjects inhaled 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). | 0 | 15 | 3 | 15 |
| EG002 | P3L 50 µg/Puff Period | Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total). | 0 | 15 | 4 | 15 |
| EG003 | P3L 80 µg/Puff Period | Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total). | 0 | 14 | 4 | 14 |
| EG004 | P3L 150 µg/Puff Period | Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total). | 0 | 14 | 8 | 14 |
| EG005 | Safety Follow-up Period | All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator entered a 7-day safety follow-up period during which (serious) adverse events can be spontaneously reported by the subjects. | 0 | 16 | 2 | 16 |
| Blood Triglycerides Increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
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| Blood Glucose Decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
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| Blood Glucose Increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood Cholesterol Increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Blood Sodium Increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.
The Intellectual Property rights and research results from the present study belong to the Sponsor.