Taste Assessment of Ozanimod

NCT ID: NCT05001152

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-09

Study Completion Date

2021-09-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Ozanimod

Intervention Type DRUG

Taste assessment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ozanimod

Taste assessment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0001

Woburn, Massachusetts, United States

Site Status

Senopsys LLC

Woburn, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IM047-013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dose Ranging Study of OTO-201 in AOMT
NCT02719158 COMPLETED PHASE2