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 Nasal Spray

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967719
• Other study ID #: ZRHM-PK-06-US
• Secondary ID: ZRHM-PK-06-US
• Status: Completed
• Phase: N/A
• Start date: October 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 the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject is aged from 22 to 65 years (inclusive).

• Smoking, healthy subject as judged by the Investigator.

• Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.

• Subject has smoked for at least the last 3 consecutive years.

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• mTHS 2.2
Single use of mTHS 2.2
• mCC
Single use of subject's own mCC
• NNS
Single administration of 1 mg of nicotine

Locations

Country	Name	City	State
United States	Central Kentucky Research Associates	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC 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 (geometric LS) means are provided.	3 days
Primary	Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC 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