NCT01925911已完成1 期
A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of IPI-145 on Single-Dose Pharmacokinetics of Midazolam (a CYP3A Substrate) in Healthy Subjects
SecuraBio2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Plasma concentrations of midazolam and 1-hydroxy-midazolam
研究概览
简要总结
To evaluate the effect of IPI-145 on the pharmacokinetics of midazolam, a cytochrome P450 3A (CYP3A) substrate; to assess the safety and tolerability of IPI-145 when administered with midazolam in healthy subjects.
详细描述
- In Treatment Period 1, subjects will receive a single 2 mg oral dose of midazolam.
- In Treatment Period 2, on Days 2-6, the same subjects will receive twice daily (BID) oral doses of 25 mg IPI-145; on Day 6, subjects will receive the morning dose of 25 mg IPI-145 concomitantly administered with 2 mg of midazolam.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women of non-childbearing potential between 18-50 years of age
- •Body Mass Index (BMI): 18.0 - 32.0 kg/m
- •In good health, determined by no clinically significant findings from clinical evaluations
- •Provided written informed consent prior to any study specific procedures
排除标准
- •Women of childbearing potential
- •Evidence of clinically significant medical conditions
- •History of gastrointestinal disease or surgery that may affect drug absorption
- •Positive or indeterminate tuberculosis-spot test at screening
- •Any active infection at the time of screening or admission
- •Subjects with acute narrow-angle glaucoma
结局指标
主要结局
Plasma concentrations of midazolam and 1-hydroxy-midazolam
时间窗: Over 24 hours
Pharmacokinetic parameters (Cmax) of midazolam and 1-hydroxy-midazolam
时间窗: Over 24 hours
Pharmacokinetic parameters (t1/2) of midazolam and 1-hydroxy-midazolam
时间窗: Over 24 hours
Pharmacokinetic parameters (AUC) of midazolam and 1-hydroxy-midazolam
时间窗: Over 24 hours
次要结局
- Incidence of adverse events following of administration midazolam, IPI-145 and the combination(2 weeks)
研究者
研究点 (2)
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