Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: CHTP 1.1 M; Other: mCC

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Saitama, Japan, 362-0021
    • Ageo Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CHTP 1.1 M then mCC; Each subject will follow the below study design: Day -1 = Wash-out (1 day); Day 1 = 1st intervention (single product use of CHTP 1.1 M); Day 2 = Wash-out; Day 3 = 2nd intervention (single product use of mCC).	Other: CHTP 1.1 M; Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M); Other: mCC; Single use of subject's own menthol conventional cigarette (mCC)
Active Comparator: mCC then CHTP 1.1 M; Each subject will follow the below study design: Day -1 = Wash-out (1 day); Day 1 = 1st intervention (single product use of mCC); Day 2 = Wash-out; Day 3 = 2nd intervention (single product use of CHTP 1.1 M).	Other: CHTP 1.1 M; Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M); Other: mCC; Single use of subject's own menthol conventional cigarette (mCC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.
• Investigators: Principal Investigator: Fumimasa Nobuoka, MD, Ageo Medical Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: smoking; cigarette; nicotine absorption; Carbon Heated Tobacco Product; potential modified risk tobacco product
• Other Study ID Numbers: P2M-PK-04-JP (Other Identifier: Philip Morris Products S.A.)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No