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A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05539976
Collaborator
(none)
10
Enrollment
8
Anticipated Duration (Days)

Study Details

Study Description

Brief Summary

The purpose of this study is to develop taste profiles of iberdomide and mezigdomide drug substances and oral formulation prototypes in order to develop a pediatric oral form of iberdomide and mezigdomide.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Open-label Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
    Anticipated Study Start Date :
    Sep 21, 2022
    Anticipated Primary Completion Date :
    Sep 29, 2022
    Anticipated Study Completion Date :
    Sep 29, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy participants who perform taste evaluations

    A maximum of 10 healthy adult participants will complete a maximum of 30 taste assessment days, to evaluate the taste characteristics of iberdomide or mezigdomide on each taste assessment day.

    Outcome Measures

    Primary Outcome Measures

    1. Taste Evaluation - Aromatic Identity [Up to 3 Months]

    2. Taste Evaluation - Amplitude [Up to 3 Months]

    3. Taste Evaluation - Mouthfeel [Up to 3 Months]

    4. Taste Evaluation - Off-notes [Up to 3 Months]

    5. Taste Evaluation - Aftertaste [Up to 3 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Participant is qualified based on training and experience.

    • Participants must be trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. Training is initially accomplished by tasting model compounds and learning to recognize and describe these accurately. These abilities are then honed and refined through additional experience in performing taste profiling.

    • Participant is qualified based on training and experience.

    • Senopsys LLC will provide all participants.

    • Participants must be trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. Training is initially accomplished by tasting model compounds and learning to recognize and describe these accurately. These abilities are then honed and refined through additional experience in performing taste profiling.

    Exclusion Criteria:

    • Participant has any history of any illness, medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might confound the results of the study or places the participant at unacceptable risk if he or she were to participate in the study.

    • Participant has a known hypersensitivity to mezigdomide, iberdomide, thalidomide, lenalidomide, or pomalidomide.

    • Participant is a female that is pregnant, breastfeeding, or is a women of childbearing potential (WOCBP).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05539976
    Other Study ID Numbers:
    • IM048-015
    First Posted:
    Sep 14, 2022
    Last Update Posted:
    Sep 14, 2022
    Last Verified:
    Sep 1, 2022

    Study Results

    No Results Posted as of Sep 14, 2022