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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 主要终点
- Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects
研究概览
简要总结
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Panel 3: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 1: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 1: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 2: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 2: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 3: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 4: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 4: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: Placebo matching BMS-708163 (Drug)
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
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
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
干预措施: Placebo matching BMS-708163 (Drug)
Panel 6: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 6: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 7: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 7: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 8: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 8: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 9: BMS-708163 or Placebo
Healthy, elderly male subjects (age: 60 years and greater)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 9: BMS-708163 or Placebo
Healthy, elderly male subjects (age: 60 years and greater)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 10: BMS-708163 or Placebo
Healthy, elderly female subjects (age: 60 years and greater)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 10: BMS-708163 or Placebo
Healthy, elderly female subjects (age: 60 years and greater)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 11: BMS-708163 or Placebo
Healthy male subjects (age: between 46 to 59 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 11: BMS-708163 or Placebo
Healthy male subjects (age: between 46 to 59 years)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 12: BMS-708163 or Placebo
Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 12: BMS-708163 or Placebo
Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 13: BMS-708163 or Placebo
Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater)
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 13: BMS-708163 or Placebo
Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater)
干预措施: Placebo matching BMS-708163 (Drug)
Panel 15: BMS-708163 or Placebo
Healthy young male subjects
干预措施: BMS-708163 (Gamma-Secretase Inhibitor) (Drug)
Panel 15: BMS-708163 or Placebo
Healthy young male subjects
干预措施: Placebo matching BMS-708163 (Drug)
结局指标
主要结局
Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects
时间窗: Within 28 days of dosing
Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
次要结局
- Effects of BMS-708163 on cortisol and QT interval corrected for heart rate(Within 28 days of dosing)
- Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets(Within 28 days of dosing)
- Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation(Within 28 days of dosing)
- Effect of food on the PK of BMS-708163 administered as a capsule formulation(Within 28 days of dosing)
- Maximum observed plasma concentration (Cmax) of BMS-708163(Within 28 days of dosing)
- Time of maximum observed plasma concentration (Tmax) of BMS-708163(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(Within 28 days of dosing)
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163(Within 28 days of dosing)
- Plasma half-life (T-HALF) of BMS-708163(Within 28 days of dosing)