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

N/ACompletedNCT01959607

Philip Morris Products S.A.65 enrolled

Overview

The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Smoking

Interventions

THS 2.2OTHER

Single use of the Tobacco Heating System 2.2 (THS 2.2)

CCOTHER

Single use of subject's own cigarette (CC)

NRT GumOTHER

Single administration of the nicotine replacement therapy (NRT) 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 smokes at least 10 commercially available CCs per day (no brand restrictions) for the last 4 weeks. * 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 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)

Koganeibashi Sakura Clinic, 2-11-25, Sakuracho, Koganei-shi

Tokyo, Japan

Outcomes

Primary Outcomes

Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC 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 THS 2.2, CC 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

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