Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: mTHS 2.2; Other: NNS; Other: mCC

• Registration Number: NCT01967719
• Lead Sponsor: Philip Morris Products S.A.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-23
• Primary Completion: 2013-11
• Study Completion: 2014-05
• Results First Submitted: 2016-02-05
• Results First Submitted QC: 2016-12-14
• Results First Posted: 2017-02-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
mTHS 2.2 then NNS	mTHS 2.2	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NNS)
mTHS 2.2 then NNS	NNS	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NNS)
NNS then mTHS 2.2	NNS	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 mTHS 2.2).
mTHS 2.2 then mCC	mTHS 2.2	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC).
mCC then mTHS 2.2	mCC	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mCC) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS 2.2).
NNS then mTHS 2.2	mTHS 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 mTHS 2.2).
mTHS 2.2 then mCC	mCC	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC).
mCC then mTHS 2.2	mTHS 2.2	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mCC) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS 2.2).

Primary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS	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	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.

Trial Locations

Locations (1)

Central Kentucky Research Associates; 🇺🇸 Lexington, Kentucky, United States