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Completed

NCT Number: NCT01780688

Exploratory THS 2.1 Nicotine Pharmacokinetics and Safety Study

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).

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Key information

Conditions

Smoking Behavior

Age range

23 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celerion, 22-24 Lisburn Road

Belfast, BT9 AD6, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 2.1

Other

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

Primary outcomes

  1. Nicotine Cmax

    Time frame: Single use (1 day)

    Maximum plasma concentration (Cmax)

  2. Nicotine AUC

    Time frame: Single use (1 day)

    Nicotine plasma concentration, area under the curve (AUCt)

Secondary outcomes

  1. Nicotine concentrations

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

    Time course of plasma nicotine concentration

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

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

    QSU-brief measuring subjective effects of smoking

  3. Safety monitoring

    Time frame: 7 days + 7 days follow-up

    Monitoring of adverse events, based on clinical and laboratory evaluation

  4. Nicotine tmax

    Time frame: Single use (1 day)

    Time to maximal nicotine concentration in plasma

  5. Cough Visual Analog Scale

    Time frame: 7 days

    Visual Analog Scale on cough

  6. Modified Cigarette Evaluation Questionnaire (MCEQ)

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

    MCEQ measuring effects of smoking

Sponsors and collaborators

Lead sponsor

Philip Morris Products S.A.

Industry

Registry information

Official study title

A Single-center, Open-label, Randomized, Controlled, Crossover Study to Explore the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System (THS) 2.1 Compared to Conventional Cigarettes Following Single and ad Libitum Use in Smoking, But Otherwise Healthy Subjects.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 31, 2013
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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