A Single-blind, Randomized, Unbalanced Crossover Design With 5 Vehicles, 5 Periods, and 5 Sequences, Repeated-doses (With no Ingestion) Study to Assess the Palatability of Eliglustat Prototype Liquid Formulations in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability
研究概览
简要总结
Primary Objective:
The purpose of this study is to assess the palatability of eliglustat prototype liquid formulations in healthy subjects.
详细描述
The total duration of the study for each subject will be approximately 5 weeks (screening period from Day -28 to Day -2, treatment period of 3 days, and follow-up call on Day 5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Concentration 1 eliglustat in vehicle A
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 1 eliglustat in vehicle B
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 1 eliglustat in vehicle C
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 1 eliglustat in vehicle D
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 2 eliglustat in vehicle A
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 1 eliglustat in vehicle E
Single dose of 5 mL solution held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 2 eliglustat in vehicle B
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 2 eliglustat in vehicle C
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 2 eliglustat in vehicle D
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 2 eliglustat in vehicle E
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 3 eliglustat in vehicle A
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 3 eliglustat in vehicle B
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 3 eliglustat in vehicle C
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 3 eliglustat in vehicle D
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
Concentration 3 eliglustat in vehicle E
Single dose of 5 mL liquid formulation held in the mouth for 15 seconds with swishing but with no ingestion
干预措施: eliglustat (Drug)
结局指标
主要结局
Measurement of palatability by 100 mm visual analogue scale (VAS) for overall acceptability
时间窗: Each day for 3 days 30 minutes post expectorating the sample
次要结局
- Subject's taste preference questionnaire from most preferred to least preferred of the 5 different liquid formulations(up to 3 days)