Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

Philip Morris Products S.A.56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Smoking

Interventions

CHTP 1.1 MOTHER

Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)

mCCOTHER

Single use of subject's own menthol conventional cigarette (mCC)

Eligibility

Sex: ALLMin age: 23 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ageo Medical Clinic

Saitama, Japan

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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