An Open-label Study to Assess the Absorption Through the Mouth After Three Repeated 50 mg Doses of Eliglustat Solution, Separated by 2-hour Intervals, Held in the Mouth for 30 Seconds With Swishing But Without Ingestion, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetic (PK) parameter AUClast
研究概览
简要总结
A study to assess the absorption of eliglustat through the mouth in healthy subjects and the safety of any systemic exposure resulting from oral surface absorption of eliglustat in healthy subjects.
详细描述
Duration of the study for each subject, not including screening, will be 3 days including follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
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
- •Body weight between 50.0 and 100.0 kg, inclusive, for males, and between 40.0 and 90.0 kg, inclusive, for females, body mass index between 18.0 and 30.0 kg/m2, inclusive.
- •Having given written informed consent prior to undertaking any study-related procedure.
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination, laboratory parameters, and ecg).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- •Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
研究组 & 干预措施
Eliglustat
Three repeated doses of eliglustat solution, separated by 2-hour intervals, held in the mouth for 30 seconds with swishing but without ingestion
干预措施: Eliglustat (Drug)
结局指标
主要结局
Plasma pharmacokinetic (PK) parameter AUClast
时间窗: Multiple timepoints on Day 1
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast (AUClast)
Plasma pharmacokinetic (PK) parameter AUC 0-2h
时间窗: Multiple timepoints on Day 1
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to 2 hours (h) post dose (AUC0-2h)
Plasma pharmacokinetic (PK) parameter AUC 2-4h
时间窗: Multiple timepoints on Day 1
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 2 hours post dose to 4 hours post dose (AUC2-4h)
Plasma pharmacokinetic (PK) parameter AUC 4-6h
时间窗: Multiple timepoints on Day 1
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 4 hours post dose to 6 hours post dose (AUC4-6h)
Plasma pharmacokinetic (PK) parameter: Cmax
时间窗: Multiple timepoints on Day 1
Maximum plasma concentration observed (Cmax)
Plasma pharmacokinetic (PK) parameter tmax
时间窗: Multiple timepoints on Day 1
Time to reach Cmax (tmax)
Plasma pharmacokinetic (PK) parameter tlast
时间窗: Multiple timepoints on Day 1
次要结局
- Treatment emergent adverse events during the study(Up to Day 3)