NCT01549106已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food and Ketoconazole on the Pharmacokinetics of IPI-145 When Administered to Healthy Adult Subjects
SecuraBio1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Safety and tolerability assessments consisting of adverse events, vital signs, 12-lead ECG, clinical laboratory tests and physical examinations will be performed following IPI-145 single and repeat oral administration in healthy subjects
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Gender : male or female
- •Age : 18-55 years, inclusive
- •Body Mass Index (BMI) : 18.0-30.0 kg/m2
- •Medical history without major pathology
- •For males only: Willingness to use adequate contraception from the time of dosing and not donate sperm until 3 months after the follow-up visit
- •Females who have a negative pregnancy test at screening and on each admission, and are of non-childbearing potential. Females of non-childbearing potential are defined as women who are surgically sterile or post-menopausal (defined as at least 1 year post cessation of menses and follicular stimulating hormone (FSH) >23.0 mIU/mL)
- •Willing and able to sign the written Informed Consent Form (ICF)
排除标准
- •Previous participation in the current study
- •Evidence of clinically relevant pathology
- •History of relevant drug and/or food allergies
- •Part 4 only: Known or suspected adverse reaction or contraindication to the imidazole class of drugs
研究组 & 干预措施
IPI-145
Experimental
干预措施: IPI-145 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability assessments consisting of adverse events, vital signs, 12-lead ECG, clinical laboratory tests and physical examinations will be performed following IPI-145 single and repeat oral administration in healthy subjects
时间窗: 8 months
Plasma concentrations of IPI-145 and metabolites
时间窗: 8 months
次要结局
未报告次要终点
研究者
研究点 (1)
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