NCT03858075已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BLU-782 When Administered Orally to Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food.
研究概览
简要总结
The main objectives of this study are to assess the safety, tolerability, pharmacokinetics (PK), and food effect of BLU-782 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically healthy
- •Non-smoker
- •Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2
- •No clinically significant cardiac history
- •No current electrocardiogram (ECG) abnormality
- •Female must not be of childbearing potential
排除标准
- •History of or current mental or legal incapacitation or major emotional problems
- •History or current clinically significant medical/psychiatric condition/disease
- •History of any illness that, in the opinion of the Investigator, might impact the results of the study or pose an additional risk to the participant
- •History or current alcoholism/drug abuse
- •History or current allergy to the study drug or a similar drug
研究组 & 干预措施
Single ascending doses with BLU-782
Experimental
干预措施: BLU-782 (Drug)
Single ascending doses with placebo
Placebo Comparator
干预措施: Placebo (Drug)
Multiple ascending doses with BLU-782
Experimental
干预措施: BLU-782 (Drug)
Multiple ascending doses with placebo
Placebo Comparator
干预措施: Placebo (Drug)
Food effect of BLU-782 taken with food
Experimental
干预措施: BLU-782 taken with food (Drug)
Food effect of BLU-782 taken without food
Experimental
干预措施: BLU-782 (Drug)
结局指标
主要结局
Comparison of the concentration-time profile of BLU-782 in plasma through day 20 when taken with or without food.
时间窗: Baseline to Day 20
Incidence and severity of adverse events (AEs) through Day 8 with a single dose of BLU-782.
时间窗: Baseline to Day 8
Incidence and severity of adverse events (AEs) through Day 17 with multiple doses of BLU-782 .
时间窗: Baseline to Day 17
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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