Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

Smoking Clinical Trial

Official title:

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466412
• Other study ID #: P2M-PK-04-JP
• Secondary ID: P2M-PK-04-JP
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: May 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 of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years and older

Eligibility

Inclusion Criteria:

• Subject is Japanese.

• Subject is at a minimum 23 years of age.

• Smoking, healthy subject as judged by the Investigator.

• Subject has smoked for at least the last 3 years

• Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

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:
• CHTP 1.1 M
Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)
• mCC
Single use of subject's own menthol conventional cigarette (mCC)

Locations

Country	Name	City	State
Japan	Ageo Medical Clinic	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 CHTP 1.1 M and mCC	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 (LS) means are provided.	Day 3: 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 Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC	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.	Day 3: 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.