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

N/ACompletedNCT01967706

Philip Morris Products S.A.73 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Smoking

Interventions

mTHSOTHER

Single use of Tobacco Heating System 2.2 Menthol (mTHS)

mCCOTHER

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

NRTOTHER

Single administration of 2 mg gum (Nicorette® 2mg)

Eligibility

Sex: ALLMin age: 23 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ageo Medical Clinic, 3133 Haraichi, Ageo-shi

Saitama, Japan

Outcomes

Primary Outcomes

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.

Time frame: 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-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT

Time frame: 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

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.