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| ID | Type | Description | Link |
|---|---|---|---|
| P2M-PK-04-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 of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHTP 1.1 M then mCC | Active Comparator | Each subject will follow the below study design:
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| mCC then CHTP 1.1 M | Active Comparator | Each subject will follow the below study design:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHTP 1.1 M | Other | Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC | 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 (LS) means are provided. | Day 3: 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 Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC | 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. | Day 3: 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 | Saitama | 362-0021 | Japan |
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Number of subjects enrolled = 56, but only 48 were randomized as described below:
Number of subjects enrolled but NOT randomized = 8
Study initiated (first subject screened): 08 May 2015
On Day -3 (admission), after all inclusion/exclusion criteria were checked, all eligible subjects were enrolled and tried CHTP 1.1 M.
From enrollment, they were asked to remain abstinent from smoking for at least 24 hours before being randomized on Day 1 into 1 of the 2 sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | CHTP 1.1 M Then mCC | Each subject will follow the below study design:
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| FG001 | mCC Then CHTP 1.1 M | Each subject will follow the below study design:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Washout Period of 1 Day (Day -1) |
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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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The overall PK population consisted of 47 subjects.
1 subject was excluded from the PK population (sequence "CHTP 1.1 M then mCC" ) due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC.
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| ID | Title | Description |
|---|---|---|
| BG000 | CHTP 1.1 M Then mCC | Each subject will follow the below study design:
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| BG001 | mCC Then CHTP 1.1 M |
| 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, 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 CHTP 1.1 M and mCC | 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 (LS) means are provided. | The PK population consisted of 47 subjects. 1 subject was excluded from the PK population (sequence "CHTP 1.1 M then mCC") due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Day 3: 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 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 56 subjects: 48 randomized subjects (24 subjects in the "CHTP 1.1 M then mCC" sequence, 24 subjects in the "mCC then CHTP 1.1 M" sequence), and 8 non-randomized subjects who were exposed to CHTP 1.1 M from the product test on Admission.
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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 | CHTP 1.1 M Then mCC | Each subject will follow the below study design:
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steffen Fredersdorf | Philip Morris Products S.A. | +41 (58) 242 2182 | Steffen.Fredersdorf@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 18, 2015 | May 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2015 | May 4, 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 conventional cigarette (mCC) |
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| NOT COMPLETED |
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Each subject will follow the below study design:
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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 | Count of Participants | Participants |
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| OG001 | Menthol Cigarette (mCC) | The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC. |
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| Primary | Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC | 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. | The PK population consisted of 47 subjects. 1 subject was excluded from the PK population (sequence "CHTP 1.1 M then mCC") due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC. | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Day 3: 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 |
| 24 |
| 0 |
| 24 |
| EG001 | mCC Then CHTP 1.1 M | Each subject will follow the below study design:
| 0 | 24 | 0 | 24 |
| EG002 | Enrolled But Not Randomized | Subjects who tried the CHTP 1.1 M at Admission but were not randomized in 1 of the 2 sequences as they were back-up subjects | 0 | 8 | 0 | 8 |
We confirm we have the contractual provisions in place which specify 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 belong to the Sponsor.