An Open-Label Taste Assessment of Ozanimod in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Taste evaluation - Aromatic identity
研究概览
简要总结
The purpose of this study is to assess the taste characteristics of ozanimod formulations, alone and mixed, in order to develop a pediatric oral form of ozanimod.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men and women, between 25 and 80 years of age.
- •Participant is a qualified sensory panelist selected by Senopsys based on training and experience
排除标准
- •Participant has any history of any illness, medical condition, laboratory abnormality, or psychiatric illness that might confound the results of the study or places the panelist at unacceptable risk if he or she were to participate in the study.
- •Participant is a female that is pregnant, nursing, or planning to become pregnant during the study.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Ozanimod
A maximum of 10 healthy adult participants (i.e., sensory panelists) will complete a maximum of 20 taste assessment days, with at least 4 panelists required to evaluate the taste characteristics of ozanimod on each taste assessment day.
干预措施: Ozanimod (Drug)
结局指标
主要结局
Taste evaluation - Aromatic identity
时间窗: Up to 6 months
Measured using the Flavor Profile method of descriptive sensory analysis
Taste evaluation - Amplitude
时间窗: Up to 6 months
Measured using the Flavor Profile method of descriptive sensory analysis
Taste evaluation - Off-notes
时间窗: Up to 6 months
Measured using the Flavor Profile method of descriptive sensory analysis
Taste evaluation - Aftertaste
时间窗: Up to 6 months
Measured using the Flavor Profile method of descriptive sensory analysis
次要结局
未报告次要终点