NCT00722358已完成2 期
Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1
Bristol-Myers Squibb5 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5
研究概览
简要总结
The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period 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
- Triple (Participant, Care Provider, 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
- •HCV RNA viral load of ≥10*5 IU/mL
- •BMI 18 to 35kg/m²
排除标准
- •Women of childbearing potential (WOCBP)
- •Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
- •HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
- •HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
- •HIV and/or HBV positive
- •Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
研究组 & 干预措施
BMS-650032
Active Comparator
干预措施: BMS-650032 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5
时间窗: To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period
次要结局
- PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032(28 days after drug)
- Safety Outcome Measures: Safety and tolerability assessments(will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days)
- Pharmacokinetic Measures: Pharmacokinetic assessments(will be done on Day 1 for one dosing interval after the AM dose and on Day 3/ or 5 for 72 hours after the last AM dose)
研究者
研究点 (5)
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