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Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it

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ClinicalTrials.gov Identifier: NCT03953183
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Brief Summary:
The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile, acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be investigated.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Other: P3P-1mg Other: P3P-2mg Not Applicable

Detailed Description:

This is a study of daily use of up to 15 P3P products over one month, including 2 confinement periods (2 overnight stays at the beginning of the study and 1 overnight stay at the end of the exposure period). During the confinement visits, nicotine PK from P3P exposure will be assessed as well as pharmacodynamic effects related to craving, sensory parameters, product experience, and product acceptance.

Between the two confinement periods, subjects will return to the investigational site for weekly ambulatory visits during which product will be resupplied and selected safety and other study assessments will be performed.

From the start of the exposure period onwards, subjects will be instructed not to smoke or use other tobacco or nicotine containing products and to use P3P exclusively.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blinded, 2-arm parallel groups, single center study
Masking: Double (Participant, Investigator)
Masking Description: Neither the site staff nor the subject will be informed about the product variant the subjects have been randomized to.
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blinded, 2-arm Parallel Groups, Single Center Study to Assess Product Use and Adaptation, Safety and Tolerability of P3P, a Novel Nicotine-containing Product, in Adult Healthy Cigarette Smokers Switching to One of Two P3P Variants for One Month.
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
P3P-1mg
Subjects randomized to exclusive use of P3P-1mg
Other: P3P-1mg
P3P-1mg (P3P product containing 1mg of nicotine.)

P3P-2mg
Subjects randomized to exclusive use of P3P-2mg
Other: P3P-2mg
P3P-2mg (P3P product containing 2mg of nicotine.)




Primary Outcome Measures :
  1. Plasma Nicotine Concentration-time Profile [ Time Frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30. ]
    To measure the plasma nicotine concentration-time profile

  2. Maximum Plasma Concentration [Cmax] [ Time Frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30. ]
    To measure the maximum nicotine plasma concentration [Cmax]

  3. Time to the Maximum Nicotine Concentration [Tmax] [ Time Frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30. ]
    To measure the time to maximum nicotine concentration [Tmax]

  4. Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [AUC(0-4h)] [ Time Frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30. ]
    To measure the area under the plasma concentration-time curve


Secondary Outcome Measures :
  1. Craving for a Cigarette [ Time Frame: Before, during and up to 4 hours post-product use on day 1 and day 30 ]
    Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).

  2. Sensory Parameters [ Time Frame: Within 60 minutes after product use on day 1 and day 30. ]
    Measured with a Sensory Questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).

  3. Product Experience [ Time Frame: Within 60 minutes after product use on day 1 and day 30. ]
    Measured with ABOUT[TM]-Product Experience questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).

  4. Tobacco Dependence [ Time Frame: Within 60 minutes after product use on day 1 and day 30. ]
    Measured with ABOUT[TM]-Dependence questionnaire. Response to each question is assessed on a 5-point scale, ranging from 1 (not at all/never) to 5 (extremely/all the time) or a 6-point scale ranging from 0 (more than 3 hours) to 5 (0-5 minutes).

  5. Product Acceptance [ Time Frame: Within 60 minutes after product use on day 1 and day 30. ]
    Measured with a Product Acceptance questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (most negative) to 7 (most positive) or as multiple choice questions.

  6. Puffing behavior of subject [ Time Frame: Evaluated by site staff on day 1 and day 30. Self-evaluated by subject on day 2, day 7, day 15, day 22, and day 29. ]
    To measure changes in subject puffing behavior. Evaluated by selection of one puffing behavior response out of three possible responses.

  7. Product Use [ Time Frame: Recorded daily by subject, in product use diary, from day 1 until day 30. ]
    To assess the number of any nicotine/tobacco products used on a daily basis.

  8. NEQ [ Time Frame: Measured at baseline, day 7, day 15, day 22, and day 29. ]
    To measure changes from baseline in Nicotine equivalents (NEQ) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.

  9. Total NNAL [ Time Frame: Measured at baseline, day 7, day 15, day 22, and day 29. ]
    To measure changes in Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.

  10. CEMA [ Time Frame: Measured at baseline, day 7, day 15, day 22, and day 29. ]
    To measure changes from baseline in 2-cyanoethylmercapturic acid (CEMA) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.

  11. CYP2A6 activity [ Time Frame: Measured before product use, on day 1 and day 30. ]
    To measure changes from baseline in CYP2A6 enzymatic activity, as measured by molar metabolic ratio of trans-3-hydroxy-cotinine/cotinine in plasma.

  12. Amount of powder extracted from P3P used for PK assessment. [ Time Frame: Before and after product use, on day 1 and day 30. ]
    Weight difference of P3P before and after use, to determine the amount of powder extracted from P3P.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has signed and dated the ICF and is able to understand the information provided in it.
  • Subject has been a smoker for at least the last 3 years prior to the Screening Visit and has smoked 5 to 15 commercially available cigarettes per day for the last 3 months prior to Screening.
  • Subject has a positive urinary cotinine test (cotinine ≥ 200 ng/mL).
  • Subject does not plan to quit smoking within 2 months.
  • Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
  • Ready to switch from smoking cigarettes to using P3P for the duration of the study.

Exclusion Criteria:

  • As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological and/or social reason).
  • Subject has a clinically relevant disease which requires medication or any other clinically significant medical condition, which as per the judgment of the Investigator would jeopardize the safety of the subject.
  • Subject has asthma condition (post-bronchodilator FEV1/FVC < 0.75 and reversibility in FEV1 ≥ 12% and > 200 mL from pre- to post-bronchodilator values).
  • Subject has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry.
  • Subject has a BMI < 18.5 kg/m2 or > 32.0 kg/m2.
  • Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer) which has an impact on CYP2A6 activity.
  • Subject has a positive serology test for HIV 1/2, Hepatitis B, or Hepatitis C.
  • Subject has a positive alcohol breath test and/or a history of alcohol disorder within the past 2 years.
  • Subject has a positive urine drug test.
  • Subject has participated in another clinical study within 3 months prior to the Screening Visit.
  • Subject has been previously screened or enrolled in this study.
  • For women only: subject is pregnant or is breastfeeding.
  • For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.

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): NCT03953183


Locations
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Russian Federation
LLC Scientific Research Center Eco-Safety
St. Petersburg, Russian Federation, 196143
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Christelle Haziza, PhD Philip Morris Products SA
Principal Investigator: Vasilyuk V Bogdanovich, MD LLC Scientific Research Center Eco-Safety

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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03953183     History of Changes
Other Study ID Numbers: P3P-SE-02-RU
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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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

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