NCT05789420CompletedNot Applicable

A Single-center, Randomized, Controlled, Open-label Study in Smoking Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles Following Single Use of Tobacco Heating System (THS) With a Regular or a Menthol Stick, Compared to Smoking of a Single Combustible Cigarette (CIG)

Philip Morris Products S.A.1 site in 1 country31 target enrollmentStarted: February 16, 2023Last updated: November 22, 2024

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Philip Morris Products S.A.
Enrollment: 31
Locations: 1
Primary Endpoint: Maximum Plasma Concentration [Cmax]

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The purpose of this study was to describe the nicotine pharmacokinetic (PK) profile during and after single use of THS (Induction heating technology, with either a regular or menthol stick) compared to singular CIG smoking in healthy adult subjects. In addition, pharmacodynamic effects (subjective effects) were evaluated to provide further insights on product acceptance and likelihood to use the THS again. Safety was assessed throughout the study.

Detailed Description

General information about the research:

Study Title:

Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG

Who carried out the research? This research was sponsored and funded by Philip Morris Products S.A.

What public involvement there was in the study? Thirty-one healthy, currently smoking, adults participated in this study.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Other
Masking: None

Eligibility Criteria

Ages: 21 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Subject has signed the ICF and is able to understand the information provided in the ICF.
•Subject has been a smoker for ≥3 years prior to the screening visit (smoking cessation attempts during this period, if any, did not last > 6 months in total).
•Subject has continuously smoked on average ≥10 commercially available regular CIG/day over the last 4 weeks. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
•Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history).
•Subject does not plan to quit smoking within the next three months.

Exclusion Criteria

•As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological, social reason).
•Subject is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners).
•Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or any other medical condition (including safety laboratory), which as per the judgment of the Investigator would jeopardize the safety of the subject.
•Subject experienced within 30 days prior to screening/admission a body temperature >37.5°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.) or the subject has a confirmed or suspected active COVID-19 infection (based on the signs and symptoms observed at the time of assessment)
•As per the Investigator's judgment, the subject has medical conditions which do or will require a medical intervention (e.g., start of treatment, surgery, hospitalization) during the study participation, which may interfere with the study participation and/or study results.
•Subject has relevant history of, or current asthma condition or COPD condition, and/or clinically significant findings.
•Subject has donated blood or received whole blood or blood products within 3 months.
•BMI < 18.5 kg/m2 or ≥ 32.0 kg/m
•Positive serology test for HIV 1/2, HBV, or HCV.
•Subject has a positive alcohol breath test and/or has a history of alcohol disorder that could interfere with their participation in the study.
•The subject has a positive urine drug test.
•Subject or one of their family members is a current or former employee of the tobacco or e-cigarette industry.
•Subject or one of their family members is an employee of the investigational site or of any other parties involved in the study.
•Subject has participated in another clinical study within 3 months.
•Subject has been previously screened or enrolled in this study.
•Subject is pregnant (does not have negative pregnancy tests at Screening and at Baseline) or is breastfeeding.
•For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.

Arms & Interventions

Product Sequence 5

Active Comparator

After at least 23 hours of abstinence from any TNP on Day 1, and after at least 23 hrs of former IP use on Day 2 and Day 3 (nicotine wash-out), subjects smoked a single CIG or perform a single use of a THS either with a regular or a menthol THS stick, according to randomized product use sequence.

The list of possible sequences are: