A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Nasal Spray
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking
- Sponsor
- Philip Morris Products S.A.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is aged from 22 to 65 years (inclusive).
- •Smoking, healthy subject as judged by the Investigator.
- •Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
- •Subject has smoked for at least the last 3 consecutive years.
Exclusion Criteria
- •As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
- •Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
- •Female subject is pregnant or breast feeding.
- •Female subject does not agree to use an acceptable method of effective contraception.
Outcomes
Primary Outcomes
Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS
Time Frame: 3 days
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS
Time Frame: 3 days
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use). Geometric Least Squares means are provided.