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Completed

NCT Number: NCT05539976

A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

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.

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Woburn, Massachusetts, 01801-6353, United States

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Primary outcomes

  1. Taste Evaluation - Aromatic Identity

    Time frame: Up to 3 Months

  2. Taste Evaluation - Amplitude

    Time frame: Up to 3 Months

  3. Taste Evaluation - Mouthfeel

    Time frame: Up to 3 Months

  4. Taste Evaluation - Off-notes

    Time frame: Up to 3 Months

  5. Taste Evaluation - Aftertaste

    Time frame: Up to 3 Months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2022
Registry last updated
Dec 1, 2022

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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