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Exploratory THS 2.1 Nicotine Pharmacokinetics and Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01780688
Recruitment Status : Completed
First Posted : January 31, 2013
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Smoking Other: Conventional cigarettes (CC) Other: THS 2.1 Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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.
Study Start Date : May 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Active Comparator: smoking conventional cigarettes (CC)
After a 1-day nicotine deprivation, subjects are smoking one single cigarette (usual own brand) on one day and then smoking ad libitum on the subsequent day
Other: Conventional cigarettes (CC)
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.

Other: THS 2.1
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

Experimental: using the Tobacco Heating System 2.1 (THS 2.1)
After a 1-day nicotine deprivation, subjects are puffing one single tobacco stick using the THS 2.1 on one day and then puffing ad libitum on the subsequent day
Other: Conventional cigarettes (CC)
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.

Other: THS 2.1
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780688


Locations
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United Kingdom
Celerion, 22-24 Lisburn Road
Belfast, United Kingdom, BT9 AD6
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Principal Investigator: Adrian J Stewart, MD Celerion, Belfast, Northern Ireland
Publications of Results:
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01780688    
Other Study ID Numbers: ZRHX-PK-02
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Keywords provided by Philip Morris Products S.A.:
Modified risk tobacco product (MRTP)
Smoking
Nicotine profile