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| Name | Class |
|---|---|
| Inflamax Research Incorporated | INDUSTRY |
| Davita Clinical Research | INDUSTRY |
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To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four different marketed electronic cigarettes. Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.
This will be a single-center, randomized, open-label, parallel study during which up to 140 healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of four (4) marketed EC products in tobacco consumers who are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e., intermittent EC users).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FT21039 Group | Experimental | 7 day at-home use of electronic cigarette FT21039 followed by a 2 day in-clinic period. |
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| FT21041 Group | Experimental | 7 day at-home use of electronic cigarette FT21041 followed by a 2 day in-clinic period. |
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| FT21044 Group | Experimental | 7 day at-home use of electronic cigarette FT21044 followed by a 2 day in-clinic period. |
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| FT21042 Group | Experimental | 7 day at-home use of electronic cigarette FT21042 followed by a 2 day in-clinic period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT21039 | Other | An electronic cigarette |
| |
| FT21041 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum baseline-adjusted nicotine plasma concentration) | To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period. | -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes |
| AUCnic0-60 | Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period. | -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax and AUCnic0-15 | Maximum baseline-adjusted plasma nicotine concentration and area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use. | -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes |
| PLoverall |
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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 males and females, 21 to 60 years of age, inclusive, at Screening Visit.
Subjects must meet one (a or b) of the following tobacco use conditions:
Willing to be confined overnight and abstain from tobacco- and nicotine- containing product use for 12 hours prior to IP use through Study Discharge.
Willing to use assigned IP during the study according to protocol.
Expired breath carbon monoxide (ECO) level is ≥10 parts per million (ppm) at the Screening Visit and Study Day 1.
Positive urine cotinine test at the Screening Visit and Study Day 1.
No intent to quit smoking or vaping from Screening to Study Day 2.
Females of childbearing age must be willing to use a form of contraception acceptable to the Investigator from the time of signing informed consent until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Lee, MD | Inflamax Research Incorporated | Principal Investigator |
| Margarita Nunez, MD | High Point Clinical Trial Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inflamax Research, Inc. | Neptune City | New Jersey | 07753 | United States | ||
| High Point Clinical Trials Center |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Other |
An electronic cigarette |
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| FT21044 | Other | An electronic cigarette |
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| FT21042 | Other | An electronic cigarette |
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Overall product liking (PL) is an additional measure of how much the subject likes the product, and is indicative of their potential willingness to seek out use of the product again at a later point in time; measured 13 minutes after the start of IP use. |
| 13 Minutes |
| High Point |
| North Carolina |
| 27265 |
| United States |