A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 (THS 2.2) Following Single Use in Smoking, Healthy Subjects Compared to Conventional Cigarettes and Nicotine Nasal Spray.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Philip Morris Products S.A.
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS
Study Overview
Brief Summary
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).
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 is Caucasian
- •Smoking, healthy subject as judged by the Investigator.
- •Subject has smoked at least 10 commercially available non menthol CCs per day (no brand restrictions) for the last 4 weeks.
- •Subject has smoked for at least the last 3 consecutive years.
- •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.
Arms & Interventions
THS 2.2 then CC
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of THS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of CC).
Intervention: THS 2.2 (Other)
CC then THS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of CC)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of THS 2.2).
Intervention: THS 2.2 (Other)
THS 2.2 then NNS
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of THS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single administration of NNS)
Intervention: THS 2.2 (Other)
THS 2.2 then NNS
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of THS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single administration of NNS)
Intervention: NNS (Other)
NNS then THS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single administration of NNS)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of THS 2.2).
Intervention: THS 2.2 (Other)
NNS then THS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single administration of NNS)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of THS 2.2).
Intervention: NNS (Other)
CC then THS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of CC)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of THS 2.2).
Intervention: CC (Other)
THS 2.2 then CC
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of THS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of CC).
Intervention: CC (Other)
Outcomes
Primary Outcomes
Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC 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.
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 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.
Secondary Outcomes
No secondary outcomes reported