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

Philip Morris Products S.A.60 enrolled

Overview

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.

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 P3P 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Pharmacokinetics

Interventions

P3P-1mgOTHER

P3P-1mg (P3P product containing 1mg of nicotine.)

P3P-2mgOTHER

P3P-2mg (P3P product containing 2mg of nicotine.)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

LLC Scientific Research Center Eco-Safety

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Plasma Nicotine Concentration-time Profile

To measure the plasma nicotine concentration-time profile following correction of baseline nicotine levels.

Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

Maximum Nicotine Concentration [cCmax]

To measure the maximum plasma nicotine concentration \[cCmax\] following correction of baseline nicotine levels.

Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

Time to the Maximum Nicotine Concentration [cTmax]

To measure the time to maximum nicotine concentration \[cTmax\] following correction of baseline nicotine levels.

Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)]

To measure the area under the plasma concentration-time curve \[cAUC(0-4h)\] following correction of baseline nicotine levels.

Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

Secondary Outcomes

Craving for a Cigarette

Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving). Over time results calculated as area under curve mm\*hour.

Time frame: Before, during and up to 4 hours post-product use on day 1 and day 30

Sensory Parameters

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).

Data from ClinicalTrials.gov

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