NCT01079819已完成1 期
Randomized, Placebo-controlled, Double-blind, Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163 in Healthy Young Male and Elderly Male and Female Chinese Subjects
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年4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
- 32
- 试验地点
- 3
- 主要终点
- Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese 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
- 否
入选标准
- •Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older
排除标准
- •Women of childbearing potential
- •Gastrointestinal disorders
- •Bleeding disorders
- •Peptic ulcer disease
- •Abnormal ECG
- •Abnormal Clinical laboratory tests
- •Abnormal Thyroid
- •Congestive heart failure
- •Cholecystectomy
- •Hypertension
- •Inability to tolerate oral medication
- •Inability to be venipunctured and/or tolerate venous access
研究组 & 干预措施
A1 (BMS-708163)
Active Comparator
干预措施: BMS-708163 (Drug)
A2 (Placebo)
Placebo Comparator
干预措施: Placebo (Drug)
B1 (BMS-708163)
Active Comparator
干预措施: BMS-708163 (Drug)
B2 (Placebo)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance
时间窗: Study Day 1 through study completion + 30 days
次要结局
- Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data(Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2)
研究者
研究点 (3)
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