Exploratory THS 2.1 Nicotine Pharmacokinetics and Safety Study

Philip Morris Products S.A.33 enrolled

Overview

The main goal of this exploratory study is to evaluate the pharmacokinetic profile of nicotine for the candidate modified risk tobacco product THS 2.1 and for conventional cigarettes (CC).

This 2-period 2-sequence cross-over clinical study intends to explore the profile of nicotine uptake (rate and extent of nicotine absorbed and associated variability) in healthy smokers switching from (CC) to THS 2.1 (single or ad libitum use) compared to smokers continuing to use CC, as a comparator. This study will serve to optimize blood sampling schedules and sample size estimation for further studies. This study will also provide preliminary information on the relationship between nicotine absorption and urge to smoke/withdrawal symptoms when using THS 2.1 as compared to CC, as well as the safety profile, which is related to the use of THS 2.1. After screening, enrolled subjects will be admitted to the clinic for 8 days. This study duration includes 2 consecutive periods. Each period consists of 1 day for single use of the product preceded by a 24-hour nicotine deprivation, and 1 day for ad libitum product use. After leaving the clinic, the subjects will be followed up for safety over a period of 7 days. This clinical study will be conducted in compliance with International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH Good Clinical Practice), the Declaration of Helsinki as amended in 2008, and the applicable regulatory requirements.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Smoking

Interventions

Conventional cigarettes (CC)OTHER

Subjects are randomized in a 1:1 fashion to be assigned to one of the 2 sequences, either A) CC and then THS 2.1, or B) THS 2.1 and then CC.

THS 2.1OTHER

Subjects are randomized in a 1:1 fashion to be assigned in one of the sequences, either A) CC and then THS 2.1, or B) THS 2.1 and then CC

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has signed an informed consent form before commencement of study procedures * Healthy Caucasian aged between 23 to 65 years * Subject is current smoker for at least 3 years (based on self-reporting and biochemically verified), who, for the last 4 weeks, had smoked at least 10 commercially available non-mentholated CC per day, and is not planning to make a quit attempt within the next 3 months Exclusion Criteria: * As per Investigator judgment, the subject should not participate in the study for any reason (e.g. medical, psychiatric and/or social reason) * The subject has a medical condition requiring smoking cessation, or has a clinically relevant disease / condition which could interfere with the study participation and/or study results * The subject has participated in a clinical study within 3 months prior to the Screening Visit * Pregnant or lactating woman, and for woman of childbearing potential, absence / refusal to use an acceptable method of effective contraception

Locations (1)

Celerion, 22-24 Lisburn Road

Belfast, United Kingdom

Outcomes

Primary Outcomes

Nicotine Cmax

Maximum plasma concentration (Cmax)

Time frame: Single use (1 day)

Nicotine AUC

Nicotine plasma concentration, area under the curve (AUCt)

Time frame: Single use (1 day)

Secondary Outcomes

Nicotine concentrations

Time course of plasma nicotine concentration

Time frame: Single use (1 day); multiple use (1 day)

Questionnaire of smoking urges (brief version) (QSU-brief)

QSU-brief measuring subjective effects of smoking

Time frame: single use (1 day); multiple use (1 day)

Safety monitoring

Monitoring of adverse events, based on clinical and laboratory evaluation

Time frame: 7 days + 7 days follow-up

Nicotine tmax

Time to maximal nicotine concentration in plasma

Time frame: Single use (1 day)

Cough Visual Analog Scale

Visual Analog Scale on cough

Time frame: 7 days

Modified Cigarette Evaluation Questionnaire (MCEQ)

MCEQ measuring effects of smoking

Time frame: single use (1 day); multiple use (1 day)

Data from ClinicalTrials.gov

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