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Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02532374
Recruitment Status : Completed
First Posted : August 25, 2015
Results First Posted : June 15, 2017
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

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.

Condition or disease Intervention/treatment Phase
Smoking Other: Nicorette® inhalator Other: P3L Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Study Start Date : October 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
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
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: 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).




Primary Outcome Measures :
  1. Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator [ 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. ]

    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.


  2. Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff [ 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. ]

    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.


  3. Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff [ 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. ]

    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.


  4. Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff [ 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. ]

    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.


  5. Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator [ 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. ]

    T0 = start of product use.

    Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).


  6. Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff [ 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. ]

    T0 = start of product use.

    Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).


  7. Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff [ 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. ]

    T0 = start of product use.

    Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).


  8. Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff [ 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. ]

    T0 = start of product use.

    Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).


  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 [ 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. ]

    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.


  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 [ 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. ]

    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.


  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 [ 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. ]

    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.


  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 [ 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. ]

    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.


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

    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.


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

    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.


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

    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.


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

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532374


Locations
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New Zealand
Christchurch Clinical Studies Trust Ltd (CCST)
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Chris Wynne, MD Christchurch Clinical Studies Trust Ltd (CCST)
Publications of Results:
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02532374    
Other Study ID Numbers: P3L-PK-01-NZ
P3L-PK-01-NZ ( Other Identifier: Philip Morris Products S.A )
First Posted: August 25, 2015    Key Record Dates
Results First Posted: June 15, 2017
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Morris Products S.A.:
nicotine absorption
nicotine containing product
adult smoker
Nicorette
nicotine delivery system
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action