A Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measurement of the minimum observed plasma drug concentration (Cmin)
研究概览
简要总结
This is a Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Healthy males or non-pregnant, non-lactating healthy females
排除标准
- •History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as judged by the investigator.
研究组 & 干预措施
Immediate Release formulation
IR Formulation
干预措施: BLU-5937 IR (Drug)
Extended Release formulation
ER formulation
干预措施: BLU-5937 ER (Drug)
结局指标
主要结局
Measurement of the minimum observed plasma drug concentration (Cmin)
时间窗: Pre dose up to 36 hours post-dose
To assess the comparison between Cmin following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the maximum observed plasma drug concentration (Cmax)
时间窗: Pre dose up to 36 hours post-dose
To assess the comparison between Cmax following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the area under the plasma drug concentration by time curve AUC
时间窗: Pre dose up to 36 hours post-dose
To assess the comparison between AUC following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
Measurement of the observed plasma drug concentration 24 hours post-dose (C24)
时间窗: 24 hours post-dose
To assess the comparison between C24 following administration of an Extended Release tablet formulation and an Immediate Release reference formulation.
次要结局
未报告次要终点