NCT01049165已完成1 期
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-813160 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年2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
- 70
- 试验地点
- 1
- 主要终点
- Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women (not of child bearing potential) ages 18 to 45
- •Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
排除标准
- •Women of Child Bearing Potential
- •Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
研究组 & 干预措施
Arm 5 (BMS-813160 or placebo)
Active Comparator
干预措施: Placebo (Drug)
Arm 5 (BMS-813160 or placebo)
Active Comparator
干预措施: BMS-813160 (Drug)
Arm 1 (BMS-813160 or placebo)
Active Comparator
干预措施: BMS-813160 (Drug)
Arm 1 (BMS-813160 or placebo)
Active Comparator
干预措施: Placebo (Drug)
Arm 2 (BMS-813160 or placebo)
Active Comparator
干预措施: BMS-813160 (Drug)
Arm 2 (BMS-813160 or placebo)
Active Comparator
干预措施: Placebo (Drug)
Arm 3 (BMS-813160 or placebo)
Active Comparator
干预措施: BMS-813160 (Drug)
Arm 3 (BMS-813160 or placebo)
Active Comparator
干预措施: Placebo (Drug)
Arm 4 (BMS-813160 or placebo)
Active Comparator
干预措施: BMS-813160 (Drug)
Arm 4 (BMS-813160 or placebo)
Active Comparator
干预措施: Placebo (Drug)
Arm 6 (BMS-813160 or placebo)
Active Comparator
干预措施: BMS-813160 (Drug)
Arm 6 (BMS-813160 or placebo)
Active Comparator
干预措施: Placebo (Drug)
Arm 7 [14C] BMS-813160
Active Comparator
干预措施: [14C] BMS-813160 (Drug)
Arm 8 (BMS-813160 or placebo)
Active Comparator
干预措施: Placebo (Drug)
Arm 8 (BMS-813160 or placebo)
Active Comparator
干预措施: BMS-813160 (Drug)
Arm 9 (BMS-813160 or placebo)
Active Comparator
干预措施: BMS-813160 (Drug)
结局指标
主要结局
Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events
时间窗: Dosing through Day 5
次要结局
- Pharmacokinetics of BMS-813160(9 times after dosing)
- Pharmacodynamics (Plasma MCP-1)(9 times post dose)
- Pharmacodynamics (Circulating monocytes)(5 times post dose)
- Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)(5 times post-dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Single Ascending Dose Study of BMS-791325 in HCV Infected SubjectsChronic Hepatitis CNCT00664625Bristol-Myers Squibb24
已完成
1 期
A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected SubjectsChronic Hepatitis CNCT00546715Bristol-Myers Squibb95
已完成
1 期
A Single Ascending Dose Study of BMS-650032 in HCV Infected SubjectsChronic Hepatitis CNCT00559247Bristol-Myers Squibb24
已完成
1 期
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy SubjectsHealthy VolunteersNCT02254369GliaCure, Inc.44
已完成
1 期
Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy SubjectsDepressionNCT00949767Bristol-Myers Squibb64