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Completed

NCT Number: NCT05001152

Taste Assessment of Ozanimod

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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Key information

Conditions

Healthy Volunteers

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Woburn, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozanimod

Drug

Taste assessment

Primary outcomes

  1. Taste evaluation - Aromatic identity

    Time frame: Up to 6 months

    Measured using the Flavor Profile method of descriptive sensory analysis

  2. Taste evaluation - Amplitude

    Time frame: Up to 6 months

    Measured using the Flavor Profile method of descriptive sensory analysis

  3. Taste evaluation - Off-notes

    Time frame: Up to 6 months

    Measured using the Flavor Profile method of descriptive sensory analysis

  4. Taste evaluation - Aftertaste

    Time frame: Up to 6 months

    Measured using the Flavor Profile method of descriptive sensory analysis

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-Label Taste Assessment of Ozanimod in Healthy Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2021
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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