Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
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ClinicalTrials.gov Identifier: NCT01967706 |
Recruitment Status :
Completed
First Posted : October 23, 2013
Results First Posted : February 2, 2016
Last Update Posted : March 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking | Other: mTHS Other: mCC Other: NRT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 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 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum. |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | May 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: mTHS then mCC
Each subject will follow the below study design:
|
Other: mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS) Other: mCC Single use of subject's own menthol cigarette (mCC) |
Active Comparator: mCC then mTHS
Each subject will follow the below study design:
|
Other: mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS) Other: mCC Single use of subject's own menthol cigarette (mCC) |
Active Comparator: mTHS then NRT
Each subject will follow the below study design:
|
Other: mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS) Other: NRT Single administration of 2 mg gum (Nicorette® 2mg) |
Active Comparator: NRT then mTHS
Each subject will follow the below study design:
|
Other: mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS) Other: NRT Single administration of 2 mg gum (Nicorette® 2mg) |
- Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC 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.
- Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC 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 |
Inclusion Criteria:
- Subject is Japanese.
- Smoking, healthy subject as judged by the Investigator.
- Subject has smoked at least 10 commercially available mCCs 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 medication (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.

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): NCT01967706
Japan | |
Ageo Medical Clinic, 3133 Haraichi, Ageo-shi | |
Saitama, Japan, 362 0021 |
Study Chair: | Christelle Haziza, PhD | Philip Morris Products S.A. | |
Principal Investigator: | Fumimasa Nobuoka, MD | Ageo Medical Clinic |
Documents provided by Philip Morris Products S.A.:
Responsible Party: | Philip Morris Products S.A. |
ClinicalTrials.gov Identifier: | NCT01967706 |
Other Study ID Numbers: |
ZRHM-PK-05-JP ZRHM-PK-05-JP ( Other Identifier: Philip Morris Products S.A. ) |
First Posted: | October 23, 2013 Key Record Dates |
Results First Posted: | February 2, 2016 |
Last Update Posted: | March 18, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Smoking Nicotine absorption Candidate modified risk tobacco product |
Cigarette Nicotine replacement therapy Nicotine gum |