Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163
2011年11月18日 更新者：Bristol-Myers Squibb
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Subjects and a Comparison to Elderly Male and Female Subjects
The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.
研究概览
地位
完全的
条件
干预/治疗
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：BMS-708163 (Gamma-Secretase Inhibitor)
- 药品：Placebo matching BMS-708163
- 药品：Placebo matching BMS-708163
研究类型
介入性
注册 (实际的)
116
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45
- Panels 9 and 10: healthy elderly males and females ages 60 and greater
- Panel 11: healthy males between the ages of 46-59
- Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74
- Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater
- Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Panel 1: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 2: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 3: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 4: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 5: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years). In Period 2: Subjects will receive BMS-708163 or placebo as a capsule formulation. In Period 3: Subjects will receive BMS-708163 or placebo as a capsule formulation within 5 minutes of consuming a standard high-fat breakfast on Day 1 |
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 6: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 7: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 8: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 9: BMS-708163 or Placebo
Healthy, elderly male subjects (age: 60 years and greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 10: BMS-708163 or Placebo
Healthy, elderly female subjects (age: 60 years and greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 11: BMS-708163 or Placebo
Healthy male subjects (age: between 46 to 59 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 12: BMS-708163 or Placebo
Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 13: BMS-708163 or Placebo
Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
实验性的：Panel 15: BMS-708163 or Placebo
Healthy young male subjects
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects
大体时间：Within 28 days of dosing
|
Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
|
Within 28 days of dosing
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Effects of BMS-708163 on cortisol and QT interval corrected for heart rate
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Effect of food on the PK of BMS-708163 administered as a capsule formulation
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Maximum observed plasma concentration (Cmax) of BMS-708163
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Time of maximum observed plasma concentration (Tmax) of BMS-708163
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-708163
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Plasma half-life (T-HALF) of BMS-708163
大体时间：Within 28 days of dosing
|
Within 28 days of dosing
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年6月1日
初级完成 (实际的)
2009年3月1日
研究完成 (实际的)
2009年3月1日
研究注册日期
首次提交
2011年10月7日
首先提交符合 QC 标准的
2011年10月17日
首次发布 (估计)
2011年10月18日
研究记录更新
最后更新发布 (估计)
2011年11月21日
上次提交的符合 QC 标准的更新
2011年11月18日
最后验证
2011年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.