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NCT05001152 Clinical Trial

Taste Assessment of Ozanimod

Healthy Volunteers Clinical Trial

Official title:
An Open-Label Taste Assessment of Ozanimod in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05001152
Other study ID # IM047-013
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 9, 2021
Est. completion date September 27, 2021

Study information
Verified date June 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date September 27, 2021
Est. primary completion date September 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 80 Years
Eligibility 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/exclusion criteria apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ozanimod
Taste assessment

Locations
Country Name City State
United States Local Institution - 0001 Woburn Massachusetts
United States Senopsys LLC Woburn Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Taste evaluation - Aromatic identity Measured using the Flavor Profile method of descriptive sensory analysis Up to 6 months
Primary Taste evaluation - Amplitude Measured using the Flavor Profile method of descriptive sensory analysis Up to 6 months
Primary Taste evaluation - Off-notes Measured using the Flavor Profile method of descriptive sensory analysis Up to 6 months
Primary Taste evaluation - Aftertaste Measured using the Flavor Profile method of descriptive sensory analysis Up to 6 months
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