Taste Assessment of Ozanimod

June 15, 2023 updated by: Bristol-Myers Squibb

An Open-Label Taste Assessment of Ozanimod in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801-6353
        • Local Institution - 0001
      • Woburn, Massachusetts, United States, 01801
        • Senopsys LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ozanimod
Taste assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taste evaluation - Aromatic identity
Time Frame: Up to 6 months
Measured using the Flavor Profile method of descriptive sensory analysis
Up to 6 months
Taste evaluation - Amplitude
Time Frame: Up to 6 months
Measured using the Flavor Profile method of descriptive sensory analysis
Up to 6 months
Taste evaluation - Off-notes
Time Frame: Up to 6 months
Measured using the Flavor Profile method of descriptive sensory analysis
Up to 6 months
Taste evaluation - Aftertaste
Time Frame: Up to 6 months
Measured using the Flavor Profile method of descriptive sensory analysis
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Actual)

September 17, 2021

Study Completion (Actual)

September 27, 2021

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM047-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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