A Phase 1, Open-Label Study of the Absorption, Distribution, Metabolism and Excretion of 14C-Labeled IPI-145 and the Absolute Bioavailability of IPI-145 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- PK parameters (AUC) and radioactivity excreted in urine and feces
研究概览
简要总结
This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.
详细描述
In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.
In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.
There will be a washout period of at least 14 days between Period 1 and Period 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2
- •In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs
- •Provision of signed and dated, written informed consent prior to any study specific procedures
排除标准
- •Evidence of clinically significant medical conditions
- •History of gastrointestinal surgery that may affect drug absorption
- •Positive or indeterminate QuantiFERON-TB Gold test at screening
- •Any active infection at the time of screening or admission
- •Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year before screening
- •Irregular defecation pattern (less than once per 2 days)
研究组 & 干预措施
IPI-145 and [14C] IPI-145
干预措施: IPI-145 (Drug)
结局指标
主要结局
PK parameters (AUC) and radioactivity excreted in urine and feces
时间窗: over 144 hours
PK parameters (t1/2) and radioactivity excreted in urine and feces
时间窗: over 144 hours
PK parameters (AUC) of IPI-145 in plasma
时间窗: over 48 hours
PK parameters (Cmax) of IPI-145 in plasma
时间窗: over 48 hours
PK parameters (t1/2) of IPI-145 in plasma
时间窗: over 48 hours
PK parameters (Cmax) and radioactivity excreted in urine and feces
时间窗: over 144 hours
次要结局
- Number of participants with adverse events following a single dose administration of IPI-145(over 4 weeks)