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

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.

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 Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: THS 2.2; Other: CC; Other: NNS

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT9 6AD
    • Celerion GB Ltd, 22-24 Lisburn Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: THS 2.2; Single use of the Tobacco Heating System 2.2 (THS 2.2); Other: CC; Single use of subject's own conventional cigarette (CC)
Active Comparator: 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).	Other: THS 2.2; Single use of the Tobacco Heating System 2.2 (THS 2.2); Other: CC; Single use of subject's own conventional cigarette (CC)
Active Comparator: 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)	Other: THS 2.2; Single use of the Tobacco Heating System 2.2 (THS 2.2); Other: NNS; Single administration of 1 mg of nicotine
Active Comparator: 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).	Other: THS 2.2; Single use of the Tobacco Heating System 2.2 (THS 2.2); Other: NNS; Single administration of 1 mg of nicotine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS	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.	3 days
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	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.	3 days

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.
• Investigators: Principal Investigator: Adrian Johnston Stewart, MD, Celerion GB Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Smoking; Modified risk tobacco product; Nicotine absorption; Nicotine replacement therapy; Conventional cigarette; Nicotine nasal spray
• Other Study ID Numbers: ZRHR-PK-01-EU (Other Identifier: Philip Morris Products S.A.); 2013-003097-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No