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

NCT ID: NCT03953183

Last Updated: 2020-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2019-10-25

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.

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 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.

Conditions

Pharmacokinetics

Keywords

Nicotine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

P3P-1mg

Subjects randomized to exclusive use of P3P-1mg

Group Type: OTHER

P3P-1mg

Intervention Type: OTHER

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

P3P-2mg

Subjects randomized to exclusive use of P3P-2mg

Group Type: OTHER

P3P-2mg

Intervention Type: OTHER

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

Interventions

P3P-1mg

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

Intervention Type: OTHER

P3P-2mg

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philip Morris Products S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christelle Haziza, PhD

Role: STUDY_CHAIR

Philip Morris Products SA

Vasilyuk V Bogdanovich, MD

Role: PRINCIPAL_INVESTIGATOR

LLC Scientific Research Center Eco-Safety

Locations

LLC Scientific Research Center Eco-Safety

Saint Petersburg, , Russia

Countries

Russia

References

Chrea C, Acquadro C, Afolalu EF, Spies E, Salzberger T, Abetz-Webb L, Cano S, Arnould B, Mainy N, Rose J, Weitkunat R. Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT Toolbox initiative. F1000Res. 2018 Dec 2;7:1878. doi: 10.12688/f1000research.16810.1. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30906527 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P3P-SE-02-RU

Identifier Type: -

Identifier Source: org_study_id