NCT00559247已完成1 期
Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年1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
- 24
- 试验地点
- 5
- 主要终点
- Safety Outcome Measures
研究概览
简要总结
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronically infected with HCV genotype 1
- •Treatment naive or treatment non-responders or treatment intolerant
- •HCV RNA viral load of ≥10*5 IU/mL
- •BMI 18 to 35kg/m²
排除标准
- •Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
- •Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
- •Co-infection with HIV or HBV
- •Women of childbearing potential
研究组 & 干预措施
or Placebo - Dose Panel 1
Experimental
Oral Suspension, 10 mg
干预措施: BMS-650032 or Placebo (Drug)
or Placebo - Dose Panel 2
Experimental
Oral Suspension 50 mg
干预措施: BMS-650032 or Placebo (Drug)
or Placebo - Dose Panel 3
Experimental
Oral Suspension, 200 mg
干预措施: BMS-650032 or Placebo (Drug)
or Placebo - Dose Panel 4
Experimental
Oral Suspension or Solution, 2.5 to 600 mg
干预措施: BMS-650032 or Placebo (Drug)
结局指标
主要结局
Safety Outcome Measures
时间窗: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
次要结局
- Pharmacokinetic Measures(Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose)
- Pharmacodynamic Measures(Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing)
研究者
研究点 (5)
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