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| ID | Type | Description | Link |
|---|---|---|---|
| ZRHM-PK-05-JP | Other Identifier | Philip Morris Products S.A. |
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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 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mTHS then mCC | Active Comparator | Each subject will follow the below study design:
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| mCC then mTHS | Active Comparator | Each subject will follow the below study design:
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| mTHS then NRT | Active Comparator | Each subject will follow the below study design:
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| NRT then mTHS | Active Comparator | Each subject will follow the below study design:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mTHS | Other | Single use of Tobacco Heating System 2.2 Menthol (mTHS) |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT | 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. | 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 |
| 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 | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Fumimasa Nobuoka, MD | Ageo Medical Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageo Medical Clinic, 3133 Haraichi, Ageo-shi | Saitama | 362 0021 | Japan |
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Enrolled population = 73 subjects: 11 exposed to mTHS and NRT at Admission but not randomized and 62 randomized as described below:
Study initiated (first subject screened): 01 August 2013
At admission (Day -1), all the subjects performed a product trial (Tobacco Sticks and subsequently NRT gum).
From enrollment, they were asked to remain abstinent from smoking for at least 24 hours (Day 0) before being randomized on Day 1 into 1 of the 4 sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | mTHS Then mCC | Each subject will follow the below study design:
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| FG001 | mCC Then mTHS | Each subject will follow the below study design:
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| FG002 | mTHS Then NRT | Each subject will follow the below study design:
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| FG003 | NRT Then mTHS | Each subject will follow the below study design:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Washout Period of 1 Day (Day 0) |
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| First Intervention (Day 1) |
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| Washout Period of 1 Day (Day 2) |
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| Second Intervention (Day 3) |
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PK population: all randomized subjects who completed at least 1 of the single-use days, with at least 1 derived PK parameter. Subjects with major protocol deviations impacting the evaluation of the results were excluded.
62 randomized subjects : 44 in Group 1, 18 in Group 2.
61 completers: 43 in Group 1 (1 withdrawn subject), 18 in Group 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | This population comprises the following sequences:
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| BG001 | Group 2 | This population comprises the following sequences:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT | 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. | PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | 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 |
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From informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject).
The safety was assessed in the safety population, consisting of 73 subjects: 62 randomized subjects (44 in Group 1, 18 in Group 2) and 11 subjects exposed to mTHS and NRT from the product trials on Day -1 but not randomized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | This population comprised the subjects that followed these intervention sequences:
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christelle HAZIZA | Philip Morris Products S.A. | +41 (58) 242 2625 | Christelle.Haziza@pmi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2013 | Mar 6, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2014 | Mar 6, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| mCC | Other | Single use of subject's own menthol cigarette (mCC) |
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| NRT | Other | Single administration of 2 mg gum (Nicorette® 2mg) |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| International Organization for Standardization (ISO) nicotine level | Number | participants |
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| OG001 | mCC - Group 1 | The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
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| OG002 | mTHS - Group 2 | The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
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| OG003 | NRT - Group 2 | The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:
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| Primary | 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 | 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. | PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations. | Posted | Least Squares Mean | 95% Confidence Interval | ng*h/mL | 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 |
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| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Group 2 | This population comprised the subjects that followed these intervention sequences:
| 0 | 18 | 1 | 18 |
| EG002 | Enrolled But Not Randomized | Subjects who tried the mTHS at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects | 0 | 11 | 0 | 11 |
We confirm we have the contractual provisions in place which specifies that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements.
The Intellectual Property rights and research results from the present study belongs to the Sponsor.