A Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of participants with clinically significant changes in Clinical laboratory tests
研究概览
简要总结
This is a Phase I, Double-Blind, Randomised, Adaptive-designed Study to Assess the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects Following Single and Multiple Oral Doses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or non-pregnant, non-lactating healthy females
排除标准
- •History of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
研究组 & 干预措施
Cohort 1
10 Japanese and 8 Caucasian subjects. 8 out of 10 Japanese subjects will receive BLU-5937 Dose A and 2 will receive placebo. All Caucasian subjects will receive BLU-5937 Dose A.
干预措施: BLU-5937 (Drug)
Cohort 2
8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose B and 2 will receive placebo.
干预措施: BLU-5937 (Drug)
Cohort 3
8 Japanese subjects. 6 out of 8 will receive BLU-5937 Dose C and 2 will receive placebo.
干预措施: BLU-5937 (Drug)
结局指标
主要结局
Number of participants with clinically significant changes in Clinical laboratory tests
时间窗: Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of ECG QTcF interval (ms) change
时间窗: Pre-dose up to 48 hours post-dose for both single and multiple administration
Number of participants with clinically significant changes in Physical Examination
时间窗: Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of diastolic and systolic blood pressure (mmHg) change
时间窗: Pre-dose up to 48 hours post-dose for both single and multiple administration
Assessment of heart rate (BPM) change
时间窗: Pre-dose up to 48 hours post-dose for both single and multiple administration
Adverse Event and Adverse Event of medical interest monitoring
时间窗: Pre-dose up to 48 hours post-dose for both single and multiple administration and again at follow-up call (1 week after discharge)
Measurement of the area under the plasma concentration by time curve (AUC)
时间窗: Pre-dose up to 48 hours post-dose for both single and multiple administration
Measurement of the maximum observed plasma drug concentration (Cmax)
时间窗: Pre-dose up to 48 hours post-dose for both single and multiple administration
次要结局
未报告次要终点