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

NCT05789420 | Completed Results

• 1 other identifier: P1-PK-12
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking, Tobacco

Keywords

Nicotine; Nicotine-containing products; Heated tobacco; Smoking; Tobacco; Tobacco Heating System; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration [Cmax]

  To measure Cmax from the single use of THS with either a regular or a menthol stick or of a single cigarette.

  Measured from start of product use to 24 hours

• Time to the Maximum Concentration [Tmax]

  To measure Tmax from the single use of THS with either a regular or a menthol stick or of a single cigarette.

  Measured from start of product use to 24 hours

• Area Under the Curve of Nicotine Plasma Concentration-time Computed From T0 to T=24 Hours [AUC0-24h]

  To measure AUC0-24h from the single use of THS with either a regular or a menthol stick or of a single cigarette.

  Measured from start of product use to 24 hours

• Area Under the Curve of Nicotine Plasma Concentration-time Computed From T0 to the Subject-specific Time of Maximum Nicotine Concentration [AUC0-t']

  To measure the area under the curve of nicotine plasma concentration-time computed from T0 to the subject-specific time of maximum nicotine concentration \[AUC0-t'\], from the single use of THS with either a regular or a menthol stick or from a single cigarette. (AUC0-Tmax)

  Measured from start of product use to 24 hours

Study Arms (6)

Product Sequence 1

ACTIVE COMPARATOR

After at least 23 hours of abstinence from any Tobacco or Nicotine Product (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 performed 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: P1R; P1M; CIG / P1R; CIG; P1M / P1M; P1R; CIG / P1M; CIG; P1R / CIG; P1R; P1M / CIG; P1M; P1R

Other: P1R stick; Other: P1M stick; Other: CIG

Product Sequence 2

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 performed 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: P1R; P1M; CIG / P1R; CIG; P1M / P1M; P1R; CIG / P1M; CIG; P1R / CIG; P1R; P1M / CIG; P1M; P1R

Other: P1R stick; Other: P1M stick; Other: CIG

Product Sequence 3

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 performed 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: P1R; P1M; CIG / P1R; CIG; P1M / P1M; P1R; CIG / P1M; CIG; P1R / CIG; P1R; P1M / CIG; P1M; P1R

Other: P1R stick; Other: P1M stick; Other: CIG

Product Sequence 4

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 performed 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: P1R; P1M; CIG / P1R; CIG; P1M / P1M; P1R; CIG / P1M; CIG; P1R / CIG; P1R; P1M / CIG; P1M; P1R

Other: P1R stick; Other: P1M stick; Other: CIG

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: P1R; P1M; CIG / P1R; CIG; P1M / P1M; P1R; CIG / P1M; CIG; P1R / CIG; P1R; P1M / CIG; P1M; P1R

Other: P1R stick; Other: P1M stick; Other: CIG

Product Sequence 6

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: P1R; P1M; CIG / P1R; CIG; P1M / P1M; P1R; CIG / P1M; CIG; P1R / CIG; P1R; P1M / CIG; P1M; P1R

Other: P1R stick; Other: P1M stick; Other: CIG

Interventions

P1R stick OTHER

Regular flavor tobacco stick

Product Sequence 1; Product Sequence 2; Product Sequence 3; Product Sequence 4; Product Sequence 5; Product Sequence 6

P1M stick OTHER

Mentholated flavor tobacco stick

Product Sequence 1; Product Sequence 2; Product Sequence 3; Product Sequence 4; Product Sequence 5; Product Sequence 6

CIG OTHER

Subjects' preferred brand of commercially available, regular or mentholated cigarettes

Product Sequence 1; Product Sequence 2; Product Sequence 3; Product Sequence 4; Product Sequence 5; Product Sequence 6

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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/m2.
• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Celerion

Belfast, BT9 6AD, United Kingdom

Location

MeSH Terms

Conditions

Tobacco Smoking; Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Limitations and Caveats

This was a single product use study, in which participants had no previous experience with the product. Therefore, it did not allow subjects to get familiar with the product.

Results Point of Contact

• Title: Xavier Jaumont, Global Head of Clinical Development and Operations
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41582421111

Study Officials

• Xavier Jaumont, MD

  Philip Morris Products S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: February 16, 2023
• Primary Completion: April 2, 2023
• Study Completion: May 5, 2023
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)