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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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The purpose of this study is to compare plasma nicotine uptake in adult snus consumers after using investigational snus products (A19010-W and B19010-F).
This will be an unblinded, randomized, multi-site, two-way crossover study to assess nicotine pharmacokinetic parameters after use of two smokeless tobacco products A19010-W and B19010-F in healthy adult snus consumers. Eligible subjects will be confined to the site for 9 days and randomized to one of two investigational product (IP) (A: A19010-W and B: B19010-F) use sequences (AB/BA). Each subject will use a single product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, and then subjects will use the other product exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A19010-W, B19010-F Use Group | Experimental | Use of product A19010-W exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, followed by use of product B19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations. |
|
| B19010-F, A19010-W Use Group | Experimental | Use of product B19010-F exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations, followed by use of product A19010-W exclusively for 4 days prior to a PK assessment for plasma nicotine concentrations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A19010-W | Other | A snus product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCnic 0-240 | Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 240 minutes after the start of a 30-minute single IP use period. | 240 minutes |
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Inclusion Criteria:
Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires;
Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of signing the ICF;
Positive urine cotinine test at the Screening Visit and Day 1;
Childbearing females must be willing to use a form of contraception acceptable to the Principal Investigator (PI) from the time of signing the ICF until study discharge; acceptable methods include:
a. Female subjects who are heterosexually active and of childbearing potential (e.g., neither surgically sterile postmenopausal) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
Female subjects who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Check in:
Subjects' primary tobacco product must be a non-mint flavor of snus. Poly use of other (non-snus) forms of tobacco- and/or nicotine-containing products will be allowed if frequency of use of other products is less than or equal to four days per week (e.g., vaping) OR less than or equal to 15 cigarettes per week.
Self-reports currently using at least one container of their usual brand (UB) snus per week for at least 3 months prior to randomization;
Agrees to exclusively use the IP and not use any other tobacco- or nicotine-containing product during the study;
Willing to comply with the requirements of the study;
Able to safely perform the required study procedures, as determined by the PI.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Hong, MD | RAIS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland Research Northwest, LLC | Rogers | Arkansas | 72758 | United States | ||
| Central Kentucky Research |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| B19010-F |
| Other |
A snus product |
|
| Lexington |
| Kentucky |
| 40509 |
| United States |
| QPS Bio-Kinetic | Springfield | Missouri | 65802 | United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| New Orleans Center for Clinical Research (NOCCR) | Knoxville | Tennessee | 37920 | United States |
| Spaulding Clinical Research, LLC | West Bend | Wisconsin | 53095 | United States |