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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02532374
Registration number
NCT02532374
Ethics application status
Date submitted
21/08/2015
Date registered
25/08/2015
Titles & IDs
Public title
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
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Scientific 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
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Secondary ID [1]
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P3L-PK-01-NZ
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Secondary ID [2]
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P3L-PK-01-NZ
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Smoking
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nicorette® inhalator
Other interventions - P3L
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 interventions: 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).
Other interventions: 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).
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator
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Assessment method [1]
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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).
Geometric Least Squares (geometric LS) means are provided.
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Timepoint [1]
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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 outcome [2]
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Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff
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Assessment method [2]
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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.
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Timepoint [2]
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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 outcome [3]
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Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff
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Assessment method [3]
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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.
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Timepoint [3]
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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 outcome [4]
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Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff
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Assessment method [4]
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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.
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Timepoint [4]
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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 outcome [5]
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Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator
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Assessment method [5]
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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).
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Timepoint [5]
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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 outcome [6]
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Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff
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Assessment method [6]
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T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).
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Timepoint [6]
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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 outcome [7]
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Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff
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Assessment method [7]
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T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).
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Timepoint [7]
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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 outcome [8]
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Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff
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Assessment method [8]
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T0 = start of product use.
Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).
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Timepoint [8]
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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 outcome [9]
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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
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Assessment method [9]
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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).
Geometric Least Squares (geometric LS) means are provided.
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Timepoint [9]
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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 outcome [10]
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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
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Assessment method [10]
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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.
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Timepoint [10]
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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 outcome [11]
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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
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Assessment method [11]
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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.
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Timepoint [11]
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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 outcome [12]
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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
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Assessment method [12]
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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.
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Timepoint [12]
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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 outcome [13]
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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
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Assessment method [13]
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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).
Geometric Least Squares (geometric LS) means are provided.
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Timepoint [13]
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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 outcome [14]
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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
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Assessment method [14]
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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.
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Timepoint [14]
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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 outcome [15]
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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
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Assessment method [15]
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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.
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Timepoint [15]
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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 outcome [16]
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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
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Assessment method [16]
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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.
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Timepoint [16]
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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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Eligibility
Key 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
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2016
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Philip Morris Products S.A.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT02532374
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Christelle Haziza, PhD
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Address
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Philip Morris Products S.A.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Teichert A, Brossard P, Felber Medlin L, Sandalic ...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT02532374