Taste Assessment of Ozanimod

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Ozanimod

• Registration Number: NCT05001152
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-11
• Study Start: 2021-09-09
• Primary Completion: 2021-09-17
• Study Completion: 2021-09-27
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ozanimod	Ozanimod	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Senopsys LLC; 🇺🇸 Woburn, Massachusetts, United States

Local Institution - 0001; 🇺🇸 Woburn, Massachusetts, United States