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| ID | Type | Description | Link |
|---|---|---|---|
| ZRHR-PK-02-JP | Other Identifier | Philip Morris Products S.A. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THS 2.2 then CC | Active Comparator | Each subject will follow the below study design:
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| CC then THS 2.2 | Active Comparator | Each subject will follow the below study design:
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| THS 2.2 then NRT | Active Comparator | Each subject will follow the below study design:
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| NRT then THS 2.2 | Active Comparator | Each subject will follow the below study design:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THS 2.2 | Other | Single use of the Tobacco Heating System 2.2 (THS 2.2) |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC 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 THS 2.2, CC 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 |
|---|---|---|
| Masayuki Sugimoto, MD PhD | Koganeibashi Sakura Clinic | Principal Investigator |
| Christelle Haziza, PhD | Philip Morris Products S.A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koganeibashi Sakura Clinic, 2-11-25, Sakuracho, Koganei-shi | Tokyo | 184-0005 | Japan |
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Enrolled population = 65 subjects: 3 subjects exposed to THS 2.2 and NRT gum at Admission but not randomized and 62 randomized to one of the four product use sequences described below:
Study initiated (first subject screened): 31 July 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 one of four product use sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | THS 2.2 Then CC | Each subject will follow the below study design:
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| FG001 | CC Then THS 2.2 | Each subject will follow the below study design:
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| FG002 | THS 2.2 Then NRT | Each subject will follow the below study design:
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| FG003 | NRT Then THS 2.2 | Each subject will follow the below study design:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Washout Period of 24 Hrs. (Day 0) |
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| First Intervention (Day 1) |
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| Washout Period of 24 Hrs. (Day 2) |
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| Second Intervention (Day 3) |
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The safety population consisted of 65 subjects:
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| ID | Title | Description |
|---|---|---|
| BG000 | THS 2.2 - CC | This population was randomized to the following product use sequence: "THS 2.2 then CC" |
| BG001 | CC -THS 2.2 | This population was randomized to the following product use sequence: "CC then THS 2.2" |
| 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 THS 2.2, CC 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 |
|
From informed consent form (ICF) signature until the end of the safety follow-up period (7 days after discharge of the subject)
The safety population consisted of 65 subjects (62 randomized subjects and 3 subjects exposed to THS 2.2 and NRT gum during the product trial on Day -1 but not randomized). Adverse events were reported according to the product use sequence and intervention. Adverse events by intervention are reported here.
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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 | THS 2.2 Use | This population used THS 2.2 as part of their randomized product use sequence |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphoria | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christelle Haziza | Philip Morris Products S.A. | +41 58 242 11 11 | clinicaltrials.pmi@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 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 7, 2014 | Mar 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| CC | Other | Single use of subject's own cigarette (CC) |
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| NRT Gum | Other | Single administration of the nicotine replacement therapy (NRT) 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 | THS 2.2 - NRT | This population was randomized to the following product use sequence: "THS 2.2 then NRT" |
| BG003 | NRT - THS 2.2 | This population was randomized to the following product use sequence: "NRT then THS 2.2" |
| BG004 | Enrolled But Not Randomized | This population comprised enrolled subjects who tried the THS 2.2 at Admission (Day -1) but were not randomized to a product use sequence. |
| BG005 | 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 | CC - 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 | THS 2.2 - 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 THS 2.2, CC 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 |
| 1 |
| 44 |
| EG001 | CC Use | This population used CC as part of their randomized product use sequence | 0 | 44 | 0 | 44 | 1 | 44 |
| EG002 | NRT Gum Use | This population used NRT Gum as part of their randomized product use sequence | 0 | 18 | 0 | 18 | 2 | 18 |
| EG003 | Enrolled But Not Randomized | This population comprised enrolled subjects who tried the THS 2.2 at Admission (Day -1) but were not randomized to a product use sequence. | 0 | 3 | 0 | 3 | 0 | 3 |
| Tobacco withdrawal symptoms | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Nervous system disorder | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
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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.