NCT05001152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

September 9, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2021

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

8 days

First QC Date

August 6, 2021

Last Update Submit

June 15, 2023

Conditions

Healthy Volunteers

Keywords

Ozanimod

Outcome Measures

Primary Outcomes (4)

  • Taste evaluation - Aromatic identity

    Measured using the Flavor Profile method of descriptive sensory analysis

    Up to 6 months

  • Taste evaluation - Amplitude

    Measured using the Flavor Profile method of descriptive sensory analysis

    Up to 6 months

  • Taste evaluation - Off-notes

    Measured using the Flavor Profile method of descriptive sensory analysis

    Up to 6 months

  • Taste evaluation - Aftertaste

    Measured using the Flavor Profile method of descriptive sensory analysis

    Up to 6 months

Study Arms (1)

Ozanimod

EXPERIMENTAL

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

Interventions

OzanimodDRUG

Taste assessment

Ozanimod

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, between 25 and 80 years of age.
  • Participant is a qualified sensory panelist selected by Senopsys based on training and experience

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution - 0001

Woburn, Massachusetts, 01801-6353, United States

Location

Senopsys LLC

Woburn, Massachusetts, 01801, United States

Location

Related Links

MeSH Terms

Interventions

ozanimod

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 11, 2021

Study Start

September 9, 2021

Primary Completion

September 17, 2021

Study Completion

September 27, 2021

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

US(2)