A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05539976
• Other study ID #: IM048-015
• Status: Completed
• Start date: September 30, 2022
• Est. completion date: November 14, 2022

Study information

• Verified date: November 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Participants

Locations

Country	Name	City	State
United States	Local Institution - 0001	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taste Evaluation - Aromatic Identity		Up to 3 Months
Primary	Taste Evaluation - Amplitude		Up to 3 Months
Primary	Taste Evaluation - Mouthfeel		Up to 3 Months
Primary	Taste Evaluation - Off-notes		Up to 3 Months
Primary	Taste Evaluation - Aftertaste		Up to 3 Months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls