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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: THS 2.2; Other: NNS; Other: CC

• Registration Number: NCT01967732
• 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 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Study Start: 2013-11
• Primary Completion: 2013-12
• Study Completion: 2014-07
• Results First Submitted: 2016-01-26
• Results First Submitted QC: 2016-07-01
• Results First Posted: 2016-08-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
THS 2.2 then NNS	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 THS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NNS)
NNS then THS 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 THS 2.2).
NNS then THS 2.2	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).
THS 2.2 then CC	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 THS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of CC).
CC then THS 2.2	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).
THS 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 THS 2.2) * Day 2 = wash-out * Day 3 = 2nd intervention (single administration of NNS)
THS 2.2 then CC	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).
CC then THS 2.2	CC	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).

Primary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC 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.
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	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)

Celerion GB Ltd, 22-24 Lisburn Road; 🇬🇧 Belfast, United Kingdom