A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of THS 2.2 Following Single Use in Healthy Smokers Compared to Conventional Cigarettes and Nicotine Gum
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking
- Sponsor
- Philip Morris Products S.A.
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NRT
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is Japanese.
- •Smoking, healthy subject as judged by the Investigator.
- •Subject smokes at least 10 commercially available CCs per day (no brand restrictions) for the last 4 weeks.
- •Subject does not plan to quit smoking in the next 3 months.
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
Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NRT
Time Frame: Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0
T0 = start of single product use. 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.
Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NRT
Time Frame: Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0
T0 = start of single product use. 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.