A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed-fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xention Ltd
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Parts 1 and 3 healthy, male subjects aged 18 to 45 years, inclusive. For Part 2 healthy, male and female subjects aged 45 to 65 years, inclusive.
- •Females must be of non-childbearing potential
排除标准
- •Subject has a known heart disease.
- •Subject has any of QTcF > 450 msec, PR ≥ 210 msec or QRS ≥ 120 msec at screening (determined from median of three readings).
- •For Part 1 only: subject has resting heart rate outside of the range 45 to 80 beats per minute (bpm) at screening (determined from median of three readings).
- •Subject has any other condition which, in the investigator's opinion will interfere with the trial.
- •Subject has a systolic blood pressure (BP) <80 or >160 mmHg at screening or a diastolic BP >90 or <45 mmHg at screening.
- •Subject has a clinically significant abnormal laboratory test result at screening.
- •Female subject who is pregnant or breast feeding and female subjects of childbearing potential.
研究组 & 干预措施
Part 1: Single Ascending Dose - Cohort 4
8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo)
干预措施: Placebo (Drug)
Part 1: Single Ascending Dose - Cohort 2
8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo)
干预措施: Placebo (Drug)
Part 1: Single Ascending Dose - Cohort 1
8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo)
干预措施: Placebo (Drug)
Part 1: Single Ascending Dose - Cohort 1
8 subjects (6 receiving 10mg XEN-D0103, 2 receiving placebo)
干预措施: 10mg XEN-D0103 (Drug)
Part 1: Single Ascending Dose - Cohort 2
8 subjects (6 receiving 30mg XEN-D0103, 2 receiving placebo)
干预措施: 30mg XEN-D0103 (Drug)
Part 1: Single Ascending Dose - Cohort 3
8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo)
干预措施: Placebo (Drug)
Part 1: Single Ascending Dose - Cohort 3
8 subjects (6 receiving 60mg XEN-D0103, 2 receiving placebo)
干预措施: 60mg XEN-D0103 (Drug)
Part 1: Single Ascending Dose - Cohort 4
8 subjects (6 receiving 120mg XEN-D0103, 2 receiving placebo)
干预措施: 120mg XEN-D0103 (Drug)
Part 1: Single Ascending Dose - Cohort 5
8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo)
干预措施: Placebo (Drug)
Part 1: Single Ascending Dose - Cohort 5
8 subjects (6 receiving 200mg XEN-D0103, 2 receiving placebo)
干预措施: 200mg XEN-D0103 (Drug)
Part 2: Fed-Fasted
17 subjects receiving 200mg XEN-D0103 with either a high fat meal or following an overnight fast.
干预措施: 200mg XEN-D0103 (Drug)
Part 3: Multiple Ascending Dose - Cohort 1
10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily)
干预措施: Placebo (Drug)
Part 3: Multiple Ascending Dose - Cohort 1
10 subjects (8 receiving 30mg XEN-D0103 twice daily, 2 receiving placebo twice daily)
干预措施: 30mg XEN-D0103 (Drug)
Part 3: Multiple Ascending Dose - Cohort 2
10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily)
干预措施: Placebo (Drug)
Part 3: Multiple Ascending Dose - Cohort 2
10 subjects (8 receiving 60mg XEN-D0103 twice daily, 2 receiving placebo twice daily)
干预措施: 60mg XEN-D0103 (Drug)
Part 3: Multiple Ascending Dose - Cohort 3
10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily)
干预措施: Placebo (Drug)
Part 3: Multiple Ascending Dose - Cohort 3
10 subjects (8 receiving 150mg XEN-D0103 once daily, 2 receiving placebo once daily)
干预措施: 150mg XEN-D0103 (Drug)
结局指标
主要结局
Number of adverse events
时间窗: Part 1: 13 days; Part 2: 13 days; Part 3: 22 days
次要结局
- Change in QTcF with XEN-D0103 and with placebo(2 days)
- Area Under Curve (AUC) of XEN-D0103 following single and multiple dose administration(Part 1: 13 days; Part 3: 22 days)
- Food effect on AUC of XEN-D0103(13 days)