A Phase 1, Open-label Taste Assessment Study of Vanzacaftor/Tezacaftor/Deutivacaftor in Healthy Adult Panelists
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method
研究概览
简要总结
The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Panelists are trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations.
排除标准
- •History of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant.
- •Sensitivity to VNZ, TEZ, or D-IVA.
- •Pregnant, nursing, or planning to become pregnant during the study
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
VNZ/TEZ/D-IVA
Participants will be given VNZ/TEZ/D-IVA FDC to retain in their mouths for approximately 10 seconds and then expectorated.
干预措施: VNZ/TEZ/D-IVA (Drug)
结局指标
主要结局
Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method
时间窗: Periodic Intervals up to 30 minutes post oral administration
次要结局
未报告次要终点