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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Sex
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
Not applicable
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
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
16
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Teichert A, Brossard P, Felber Medlin L, Sandalic ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02532374