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

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: NCT01967732
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : August 15, 2016
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
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Brief Summary:
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 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).

Condition or disease Intervention/treatment Phase
Smoking Other: THS 2.2 Other: CC Other: NNS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 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 Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 (THS 2.2) Following Single Use in Smoking, Healthy Subjects Compared to Conventional Cigarettes and Nicotine Nasal Spray.
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: THS 2.2 then CC

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of THS 2.2)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of CC).
 Other: THS 2.2
Single use of the Tobacco Heating System 2.2 (THS 2.2)

Other: CC
Single use of subject's own conventional cigarette (CC)
Active Comparator: CC then THS 2.2

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of CC)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of THS 2.2).
 Other: THS 2.2
Single use of the Tobacco Heating System 2.2 (THS 2.2)

Other: CC
Single use of subject's own conventional cigarette (CC)
Active Comparator: THS 2.2 then NNS

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of THS 2.2)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single administration of NNS)
 Other: THS 2.2
Single use of the Tobacco Heating System 2.2 (THS 2.2)

Other: NNS
Single administration of 1 mg of nicotine
Active Comparator: NNS then THS 2.2

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single administration of NNS)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of THS 2.2).
 Other: THS 2.2
Single use of the Tobacco Heating System 2.2 (THS 2.2)

Other: NNS
Single administration of 1 mg of nicotine


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS [ Time Frame: 3 days ]

    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.


  2. 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 NNS [ Time Frame: 3 days ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is Caucasian
  • Smoking, healthy subject as judged by the Investigator.
  • Subject has smoked at least 10 commercially available non menthol CCs 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 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.
Contacts and Locations
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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): NCT01967732


Locations
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United Kingdom
Celerion GB Ltd, 22-24 Lisburn Road
Belfast, United Kingdom, BT9 6AD
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Adrian Johnston Stewart, MD Celerion GB Ltd.
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] August 11, 2014
Statistical Analysis Plan  [PDF] May 8, 2014

More Information
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01967732    
Other Study ID Numbers: ZRHR-PK-01-EU
ZRHR-PK-01-EU ( Other Identifier: Philip Morris Products S.A. )
2013-003097-27 ( EudraCT Number )
First Posted: October 23, 2013    Key Record Dates
Results First Posted: August 15, 2016
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philip Morris Products S.A.:
Smoking
Nicotine absorption
Modified risk tobacco product
 Conventional cigarette
Nicotine replacement therapy
Nicotine nasal spray