NCT01057030已完成1 期
Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2010年3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
- 22
- 试验地点
- 1
- 主要终点
- BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese and non-Japanese subjects
- •Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
- •Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
- •BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
- •Men ages 20 to 45 years
排除标准
- •Serum creatinine values above the normal range
- •Urine protein or blood levels above the normal range
- •Liver function tests above the normal range
- •TSH, free T3, or free T4 outside the normal range
- •Amylase or lipase levels above the normal range
- •Positive Fecal Immunochemical Test (FIT™)
研究组 & 干预措施
A1 (BMS-708163)
Active Comparator
Healthy Japanese Subjects
干预措施: BMS-708163 (Drug)
A2 (Placebo)
Placebo Comparator
Healthy Japanese Subjects
干预措施: Placebo (Drug)
B1 (BMS-708163)
Active Comparator
Healthy Non-Japanese Subjects
干预措施: BMS-708163 (Drug)
B2 (Placebo)
Placebo Comparator
Healthy Non-Japanese Subjects
干预措施: Placebo (Drug)
结局指标
主要结局
BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)
时间窗: Every day for 28 days
次要结局
- BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))(Days 1, 7, and 14)
研究者
研究点 (1)
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