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

Smoking Clinical Trial

Official title:

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967706
• Other study ID #: ZRHM-PK-05-JP
• Secondary ID: ZRHM-PK-05-JP
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2020
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS)
• mCC
Single use of subject's own menthol cigarette (mCC)
• NRT
Single administration of 2 mg gum (Nicorette® 2mg)

Locations

Country	Name	City	State
Japan	Ageo Medical Clinic, 3133 Haraichi, Ageo-shi	Saitama

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	Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT	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.	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
Primary	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	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.	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