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: CC; Other: NRT Gum

• Registration Number: NCT01959607
• Lead Sponsor: Philip Morris Products S.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Primary Completion: 2013-11
• Study Completion: 2014-04
• Results First Submitted: 2015-04-24
• Results First Submitted QC: 2015-06-29
• Results First Posted: 2015-07-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
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).
NRT then THS 2.2	NRT Gum	Each subject will follow the below study design: * Day 0 = Wash-out (1 day) * Day 1 = 1st intervention (single administration of NRT gum \[Nicorette® 2mg\]) * 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).
NRT 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 NRT gum \[Nicorette® 2mg\]) * Day 2 = wash-out * Day 3 = 2nd intervention (single product use of THS 2.2).
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	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 NRT	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 NRT gum \[Nicorette® 2mg\]).
THS 2.2 then NRT	NRT Gum	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 NRT gum \[Nicorette® 2mg\]).

Primary Outcome Measures

Name	Time	Method
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	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	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)

Koganeibashi Sakura Clinic, 2-11-25, Sakuracho, Koganei-shi; 🇯🇵 Tokyo, Japan