NCT05539976已完成不适用
An Open-label Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Taste Evaluation - Aftertaste
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Taste Evaluation - Aftertaste
时间窗: Up to 3 Months
Taste Evaluation - Amplitude
时间窗: Up to 3 Months
Taste Evaluation - Off-notes
时间窗: Up to 3 Months
Taste Evaluation - Aromatic Identity
时间窗: Up to 3 Months
Taste Evaluation - Mouthfeel
时间窗: Up to 3 Months
次要结局
未报告次要终点
研究者
研究点 (1)
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