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