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

Smoking Clinical Trial

Official title:

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of THS 2.2 Following Single Use in Healthy Smokers Compared to Conventional Cigarettes and Nicotine Gum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959607
• Other study ID #: ZRHR-PK-02-JP
• Secondary ID: ZRHR-PK-02-JP
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: June 29, 2015
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine gum in a Japanese population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• THS 2.2
Single use of the Tobacco Heating System 2.2 (THS 2.2)
• CC
Single use of subject's own conventional cigarette (CC)
• NRT Gum
Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette ® 2mg)

Locations

Country	Name	City	State
Japan	Koganeibashi Sakura Clinic, 2-11-25, Sakuracho, Koganei-shi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of the Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2 and CC (Group 1)	Based on the primary outcome, only the ratio THS 2.2:CC is presented.; The ratio THS 2.2:CC of Cmax takes into consideration the blood measurements taken at both Day 1 (THS 2.2) and Day 3 (CC) for the sequence "THS 2.2 then CC", and Day 1 (CC) and Day 3 (THS 2.2) for the sequence "CC then THS 2.2".	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)	No
Primary	Ratio of the Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2 and CC (Group 1)	Based on the primary outcome, only the ratio THS 2.2:CC is presented.; The ratio THS 2.2:CC of AUC(0-last) takes into consideration the blood measurements taken at both Day 1 (THS 2.2) and Day 3 (CC) for the sequence "THS 2.2 then CC", and Day 1 (CC) and Day 3 (THS 2.2) for the sequence "CC then THS 2.2".	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)	No