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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five different marketed electronic cigarettes, or one combustible cigarette (CC). 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 210 healthy adult subjects, consisting of 35 subjects per product group, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of five different marketed ECs or one CC 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 |
|---|---|---|---|
| FT210771 Group | Experimental | 7 day at-home use of electronic cigarette FT210771 followed by a 2 day in-clinic period. |
|
| FT210751 Group | Experimental | 7 day at-home use of electronic cigarette FT210751 followed by a 2 day in-clinic period. |
|
| 6T30134157764 Group | Experimental | 7 day at-home use of electronic cigarette 6T30134157764 followed by a 2 day in-clinic period. |
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| G41A7C071 Group | Experimental | 7 day at-home use of electronic cigarette G41A7C071 followed by a 2 day in-clinic period. |
|
| M011161212 Group | Experimental | 7 day at-home use of electronic cigarette M011161212 followed by a 2 day in-clinic period. |
|
| FT21002 Group | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT210771 | Other | An electronic cigarette |
| |
| FT210751 |
| 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 | Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use. | -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes |
| AUCnic0-15 | Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use. |
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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:
i. Smoking ≥ 10 cigarettes per day for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation will be allowed at the discretion of the PI; and ii. Using a nicotine-containing "cig-a-like" EC or a tank system EC either daily or at least weekly for at least 3 months prior to Screening Visit.
Willing to be confined overnight and abstain from tobacco- and nicotine-containing product use (with the exception of study IP 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 PI 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 |
|---|---|---|
| Corey Anderson, MD | Clinical Research Consortium (CRC) | Principal Investigator |
| Mark Adams, MD | Central Kentucky Research Associates (CKRA) | Principal Investigator |
| Daniel Gruener, MD | St. Louis Clinical Trials (SLCT) | Principal Investigator |
| Otto Dueno, MD | Midwest Clinical Research (MCRC) | Principal Investigator |
| William Smith, MD | New Orleans Center for Clinical Research (NOCCR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Consortium (CRC) | Tempe | Arizona | 85283 | United States | ||
| Central Kentucky Research Associates (CKRA) |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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7 day at-home use of combustible cigarette FT21002 followed by a 2 day in-clinic period.
|
| Other |
An electronic cigarette |
|
| 6T30134157764 | Other | An electronic cigarette |
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| G41A7C071 | Other | An electronic cigarette |
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| M011161212 | Other | An electronic cigarette |
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| FT21002 | Other | A combustible cigarette |
|
| -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes |
| PLoverall | 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 |
| Lexington |
| Kentucky |
| 40509 |
| United States |
| St. Louis Clinical Trials (SLCT) | St Louis | Missouri | 63141 | United States |
| Midwest Clinical Research (MCRC) | Dayton | Ohio | 45417 | United States |
| New Orleans Center for Clinical Research (NOCCR) | Knoxville | Tennessee | 37920 | United States |