A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants

An Open-label 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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801-6353
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of healthy volunteers who are qualified based on training and experience in performing taste evaluations.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Taste Evaluation - Aromatic Identity	Up to 3 Months
Taste Evaluation - Amplitude	Up to 3 Months
Taste Evaluation - Mouthfeel	Up to 3 Months
Taste Evaluation - Off-notes	Up to 3 Months
Taste Evaluation - Aftertaste	Up to 3 Months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IM048-015