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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02532374




Registration number
NCT02532374
Ethics application status
Date submitted
21/08/2015
Date registered
25/08/2015
Date last updated
23/01/2018

Titles & IDs
Public title
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
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
Secondary ID [1] 0 0
P3L-PK-01-NZ
Secondary ID [2] 0 0
P3L-PK-01-NZ
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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).

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
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.
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
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.
Primary outcome [5] 0 0
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).
Timepoint [5] 0 0
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.
Primary outcome [6] 0 0
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).
Timepoint [6] 0 0
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.
Primary outcome [7] 0 0
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).
Timepoint [7] 0 0
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.
Primary outcome [8] 0 0
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).
Timepoint [8] 0 0
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.
Primary outcome [9] 0 0
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.
Timepoint [9] 0 0
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.
Primary outcome [10] 0 0
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.
Timepoint [10] 0 0
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.
Primary outcome [11] 0 0
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.
Timepoint [11] 0 0
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.
Primary outcome [12] 0 0
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.
Timepoint [12] 0 0
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.
Primary outcome [13] 0 0
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.
Timepoint [13] 0 0
Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Primary outcome [14] 0 0
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.
Timepoint [14] 0 0
Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Primary outcome [15] 0 0
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.
Timepoint [15] 0 0
Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.
Primary outcome [16] 0 0
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.
Timepoint [16] 0 0
Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.

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
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Other
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Philip Morris Products S.A.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02532374
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christelle Haziza, PhD
Address 0 0
Philip Morris Products S.A.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications