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

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ClinicalTrials.gov Identifier: NCT01959607
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : July 28, 2015
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 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 THS 2.2 Following Single Use in Healthy Smokers Compared to Conventional Cigarettes and Nicotine Gum
Study Start Date : July 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


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 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 cigarette (CC)

Active Comparator: THS 2.2 then NRT

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 NRT gum [Nicorette® 2mg]).
Other: THS 2.2
Single use of the Tobacco Heating System 2.2 (THS 2.2)

Other: NRT Gum
Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)

Active Comparator: NRT 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 NRT gum [Nicorette® 2mg])
  • 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: NRT Gum
Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)




Primary Outcome Measures :
  1. Maximum Concentration (Cmax) of Nicotine 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 ]

    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.


  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 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 ]

    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.




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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 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.

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): NCT01959607


Locations
Japan
Koganeibashi Sakura Clinic, 2-11-25, Sakuracho, Koganei-shi
Tokyo, Japan, 184-0005
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
Principal Investigator: Masayuki Sugimoto, MD PhD Koganeibashi Sakura Clinic
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.

Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01959607     History of Changes
Other Study ID Numbers: ZRHR-PK-02-JP
ZRHR-PK-02-JP ( Other Identifier: Philip Morris Products S.A. )
First Posted: October 10, 2013    Key Record Dates
Results First Posted: July 28, 2015
Last Update Posted: September 5, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Philip Morris Products S.A.:
Smoking
Nicotine absorption
Candidate modified risk tobacco product
Cigarettes
Nicotine Replacement Therapy gum (NRT gum)

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action