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A single-center, randomized, controlled, partially blinded, crossover study to evaluate the pharmacokinetics and pharmacodynamics of nicotine following use of two variants of VM 1.0, VM16 and VM32, a nicotine-containing aerosol generator compared to cigarettes in adult current smokers. The participants will be blinded to the variants of VM 1.0 and to the randomized product use sequences. The study will be conducted with 3 periods and 3 sequences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product Sequence 1 | Active Comparator | On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette |
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| Product Sequence 2 | Active Comparator | On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette |
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| Product Sequence 3 | Active Comparator | On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VM16 | Other | VM16 contains a liquid with a nicotine concentration of 1.6% |
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| Measure | Description | Time Frame |
|---|---|---|
| Nicotine concentration | To measure the observed plasma nicotine concentration [C -5min] and [C 12hours], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking. | From 5 minutes prior to product use to 12 hours after product use |
| Maximum nicotine concentration | To measure the maximum observed plasma nicotine concentration [Cmax], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking. | From 5 minutes prior to product use to 12 hours after product use |
| Area under the observed plasma nicotine concentration-time curve (AUC) | To measure the area under the observed plasma nicotine concentration-time curve (AUC) from the start the first puff (T0) to the timepoint of last quantifiable concentration [AUC 0-last] and extrapolated to infinity [AUC 0-infinity] | From 5 minutes prior to product use to 12 hours after product use |
| Time to the observed maximum concentration [Tmax] | To measure the time to the observed maximum concentration [Tmax], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking. | From 5 minutes prior to product use to 12 hours after product use |
| Elimination rate constant [kel] | To measure the elimination rate constant [kel]], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Jaumont, MD | Philip Morris Products S.A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Belfast | BT9 6AD | United Kingdom |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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This is a partially blinded study: the participants will be blinded to the variants of VM 1.0 and to the randomized product use sequences. As part of the PMP quality control (QC) activity, a blinded data review will be performed before database lock. Data listings will be reviewed by the CRO and PMP, with no access to the product information for data review team members. Full details will be available in the data review plan.
| VM32 | Other | VM32 contains a liquid with a nicotine concentration of 3.2% |
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| Cigarette (CC) | Other | Subjects will provide their own usual brand of commercially available cigarettes |
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| From 5 minutes prior to product use to 12 hours after product use |
| Half-life of nicotine [t1/2] | To measure half-life of nicotine [t1/2], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking. | From 5 minutes prior to product use to 12 hours after product use |