NCT01947777已完成1 期
A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 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10月1日最近更新:
适应症
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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
- Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656
研究概览
简要总结
To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when administered with rifampin in healthy subjects
详细描述
- In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
- In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg IPI-145 concomitantly administered with 600 mg of rifampin
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/m2
- •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
- •Consumption of any nutrients known to modulate cytochrome P450 enzyme activity within 14 days prior to administration of study drug, during the study, and until after discharge
结局指标
主要结局
Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656
时间窗: Over 48 hours
Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656
时间窗: Over 48 hours
Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656
时间窗: Over 48 hours
Plasma concentrations of IPI-145 and its metabolite, IPI-656
时间窗: Over 48 hours
次要结局
- Incidence of adverse events following administration of IPI-145, rifampin, and the combination.(2 weeks)
研究者
研究点 (2)
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