Healthy Volunteers
Conditions
Keywords
Ozanimod
Brief summary
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.
Interventions
DRUGOzanimod
Taste assessment
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women, between 25 and 80 years of age. * Participant is a qualified sensory panelist selected by Senopsys based on training and experience
Exclusion criteria
* Participant has any history of any illness, medical condition, laboratory abnormality, or psychiatric illness that might confound the results of the study or places the panelist at unacceptable risk if he or she were to participate in the study. * Participant is a female that is pregnant, nursing, or planning to become pregnant during the study. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Taste evaluation - Aromatic identity | Up to 6 months | Measured using the Flavor Profile method of descriptive sensory analysis |
| Taste evaluation - Amplitude | Up to 6 months | Measured using the Flavor Profile method of descriptive sensory analysis |
| Taste evaluation - Off-notes | Up to 6 months | Measured using the Flavor Profile method of descriptive sensory analysis |
| Taste evaluation - Aftertaste | Up to 6 months | Measured using the Flavor Profile method of descriptive sensory analysis |
Countries
United States
Outcome results
None listed