A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

Completed

• Conditions: Healthy Participants

• Registration Number: NCT05539976
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Study Start: 2022-09-30
• Status Verified: 2022-11
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Taste Evaluation - Aftertaste	Up to 3 Months
Taste Evaluation - Amplitude	Up to 3 Months
Taste Evaluation - Off-notes	Up to 3 Months
Taste Evaluation - Aromatic Identity	Up to 3 Months
Taste Evaluation - Mouthfeel	Up to 3 Months

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Woburn, Massachusetts, United States