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| ID | Type | Description | Link |
|---|---|---|---|
| ZRHM-PK-06-US | Other Identifier | Philip Morris Products S.A. |
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The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mTHS 2.2 then mCC | Active Comparator | Each subject will follow the below study design:
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| mCC then mTHS 2.2 | Active Comparator | Each subject will follow the below study design:
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| mTHS 2.2 then NNS | Active Comparator | Each subject will follow the below study design:
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| NNS then mTHS 2.2 | Active Comparator | Each subject will follow the below study design:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mTHS 2.2 | Other | Single use of mTHS 2.2 |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS | 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 (geometric LS) means are provided. | 3 days |
| Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS | 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. | 3 days |
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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 |
| James L Borders, MD | Central Kentucky Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | United States |
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Enrolled population = 64 subjects: 2 exposed to mTHS 2.2 and NNS at Admission but not randomized and 62 randomized as described below:
Study initiated (first subject screened): 02 October 2013
At admission (Day -1), all the subjects performed a product trial (mTHS 2.2 and subsequently NNS).
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 2.2 Then mCC | Each subject will follow the below study design:
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| FG001 | mCC Then mTHS 2.2 | Each subject will follow the below study design:
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| FG002 | mTHS 2.2 Then NNS | Each subject will follow the below study design:
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| FG003 | NNS Then mTHS 2.2 | 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.
62 randomized subjects : 44 in Group 1, 18 in Group 2.
PK population = 58 => 41 in Group 1 (2 withdrawn + 1 excluded due to major protocol deviation), 17 in Group 2 (1 withdrawn).
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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 |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 2.2, mCC and NNS | 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 (geometric LS) means are provided. | Pharmacokinetics (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 | 3 days |
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From the 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 64 subjects: 62 randomized subjects (44 in Group 1, 18 in Group 2) and 2 subjects exposed to mTHS 2.2 and NNS 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 comprises the following sequences:
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christelle HAZIZA, PhD | 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 | May 22, 2013 | Mar 6, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 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 mCC |
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| NNS | Other | Single administration of 1 mg of nicotine |
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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 yield | 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 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 | NNS - 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 Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS | 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 | h*ng/mL | 3 days |
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| 0 |
| 44 |
| 12 |
| 44 |
| EG001 | Group 2 | This population comprises the following sequences:
| 0 | 18 | 5 | 18 |
| EG002 | Enrolled But Not Randomized | Subjects who tried the mTHS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects | 0 | 2 | 0 | 2 |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 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.