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; Other: mCC; Other: NRT

• Registration Number: NCT01967706
• Lead Sponsor: Philip Morris Products S.A.

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 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• 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: 2015-06-10
• Results First Submitted QC: 2015-12-29
• Results First Posted: 2016-02-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Subject is Japanese.
• Smoking, healthy subject as judged by the Investigator.
• Subject has smoked at least 10 commercially available mCCs 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 medication (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
mCC then mTHS	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).
mTHS then NRT	NRT	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NRT)
NRT then mTHS	mTHS	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single administration of NRT) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS).
mTHS then mCC	mTHS	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC).
mTHS 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) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mCC).
mCC then mTHS	mTHS	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).
mTHS then NRT	mTHS	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single product use of mTHS) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NRT)
NRT then mTHS	NRT	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single administration of NRT) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of mTHS).

Primary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT	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.
Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT	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.

Trial Locations

Locations (1)

Ageo Medical Clinic, 3133 Haraichi, Ageo-shi; 🇯🇵 Saitama, Japan