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The purpose of this study is to assess the taste characteristics of ozanimod formulations, alone and mixed, in order to develop a pediatric oral form of ozanimod.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozanimod | Experimental | A maximum of 10 healthy adult participants (i.e., sensory panelists) will complete a maximum of 20 taste assessment days, with at least 4 panelists required to evaluate the taste characteristics of ozanimod on each taste assessment day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | Taste assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Taste evaluation - Aromatic identity | Measured using the Flavor Profile method of descriptive sensory analysis | Up to 6 months |
| Taste evaluation - Amplitude | Measured using the Flavor Profile method of descriptive sensory analysis | Up to 6 months |
| Taste evaluation - Off-notes | Measured using the Flavor Profile method of descriptive sensory analysis | Up to 6 months |
| Taste evaluation - Aftertaste | Measured using the Flavor Profile method of descriptive sensory analysis | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Woburn | Massachusetts | 01801-6353 | United States | ||
| Senopsys LLC |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
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| Woburn |
| Massachusetts |
| 01801 |
| United States |
| FDA Safety Alerts and Recalls | View source |