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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This study will examine elements of abuse liability (AL) related to potential product adoption of three electronic tobacco vapor products by current smokers relative to high and low AL comparator products (usual brand cigarette and nicotine gum, respectively). Changes in subjective measures, speed and amount of nicotine uptake, and maximum changes in physiological effects during and after product use that follows a 12-hour (minimum) tobacco and nicotine abstinence period, will be determined. The electronic tobacco vapor products will not be compared to each other.
This is a single-center, randomized, open-label, crossover study, designed to evaluate subjective effects (i.e., Product Liking [PL], Overall Intent to Use Again [OIUA], Product Effects [PE], Urge to Smoke [UTS], and Overall Product Liking [OPL]), plasma nicotine uptake, and physiological measures (blood pressure and heart rate) during and following ad libitum use of the following five IPs by healthy subjects. Subjects will be evaluated in five separate Test Sessions and the active period of each Test Session will last for approximately 4 hours during and following IP use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product usage order ABECD | Experimental | Subjects will use each of the 5 products (ABECD) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product usage order BCADE | Experimental | Subjects will use each of the 5 products (BCADE) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product usage order CDBEA | Experimental | Subjects will use each of the 5 products (CDBEA) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product usage order DECAB | Experimental | Subjects will use each of the 5 products (DECAB) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product A | Other | Usual Brand Cigarette |
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| Measure | Description | Time Frame |
|---|---|---|
| AUECPL 15-240 | Area under the product liking (PL) NRS score-versus-time curve from 15 minutes to 240 minutes after the start of investigational product (IP) use. | -5, 5, 15, 30, 45, 60, 90, 120, 150, 180, and 240 Minutes |
| Emax PL | Maximum response for product effects with regards to PL score after the start of IP use. | -5, 5, 15, 30, 45, 60, 90, 120, 150, 180, and 240 Minutes |
| Eoverall IUA | Overall intent to use again (IUA), measured at 240 minutes after the start of IP use. | 240 Minutes |
| AUCnic 0-240 | Baseline-adjusted area under the nicotine concentration-versus-time curve from time zero to 240 minutes after the start of IP use. | -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes. |
| Cmax | Maximum baseline-adjusted plasma concentration. | -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes. |
| Tmax | Time to maximum baseline-adjusted plasma concentration. | -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, and 240 Minutes. |
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Inclusion Criteria:
Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
Able to safely perform the required study procedures, as determined by the Investigator.
Expired breath carbon monoxide level is ≥ 15 ppm and ≤ 100 ppm at Screening and Day 1.
Smokes only combustible, filtered, non-menthol cigarettes, 83 mm to 100 mm in length.
Agrees to smoke same usual brand (UB) cigarette throughout the study period. Usual brand cigarette is defined as the cigarette brand style currently smoked most frequently by the subject.
Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Investigator.
Response at Screening to Fagerström Test for Cigarette Dependence (FTCD) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes."
Willing to use UB cigarette, electronic tobacco vapor products, and Nicorette gum during the study period.
Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each Test Session.
Females of childbearing potential must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until study discharge. Examples of acceptable forms of contraception include, but are not limited to, the following.
Surgeries:
Transcervical sterilization at least 6 months prior to randomization
Hormonal birth control at least 3 months prior to randomization
Non-hormonal intrauterine device at least 3 months prior to randomization
Double barrier methods (e.g., condom and spermicide) at least 14 days prior to randomization
Abstinence at least 14 days prior to randomization
Vasectomized partner is acceptable birth control for females provided the surgery was performed at least 6 months prior to randomization
Postmenopausal at least 1 year prior to randomization and have follicle-stimulating hormone (FSH) levels consistent with postmenopausal status at screening as per Investigator or designee judgment
Agrees to in-clinic confinement of 11 days and 10 nights.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Tomek, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Lincoln | Nebraska | 68502 | United States |
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| Product usage order EADBC | Experimental | Subjects will use each of the 5 products (EADBC) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product usage order DCEBA | Experimental | Subjects will use each of the 5 products (DCEBA) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product usage order EDACB | Experimental | Subjects will use each of the 5 products (EDACB) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product usage order AEBDC | Experimental | Subjects will use each of the 5 products (AEBDC) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product usage order BACED | Experimental | Subjects will use each of the 5 products (BACED) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product usage order CBDAE | Experimental | Subjects will use each of the 5 products (CBDAE) sequentially for 1 and 1/2 days during an 11 day confinement, followed by a 4 hour Test Session. |
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| Product B | Other | FT21039 an electronic tobacco vapor product |
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| Product C | Other | FT21092 an electronic tobacco vapor product |
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| Product D | Other | FT21018 an electronic tobacco vapor product |
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| Product E | Other | 4mg nicotine gum |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
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| C476054 | HTR3D protein, human |
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