Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-791325 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
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
- 6
- 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-791325 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 35 kg/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
研究组 & 干预措施
1
BMS-791325 (100 mg)
or
placebo match for (100 mg)
干预措施: BMS-791325 (Drug)
1
BMS-791325 (100 mg)
or
placebo match for (100 mg)
干预措施: Placebo (Drug)
2
BMS-791325 (300 mg)
or
placebo match for (300 mg)
干预措施: BMS-791325 (Drug)
2
BMS-791325 (300 mg)
or
placebo match for (300 mg)
干预措施: Placebo (Drug)
3
BMS-791325 (900 mg)
or
placebo match for (900 mg)
干预措施: BMS-791325 (Drug)
3
BMS-791325 (900 mg)
or
placebo match for (900 mg)
干预措施: Placebo (Drug)
4
BMS-791325 (potential dose between 10-800 mg)
or
placebo match for (10-800 mg)
干预措施: BMS-791325 (Drug)
4
BMS-791325 (potential dose between 10-800 mg)
or
placebo match for (10-800 mg)
干预措施: 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)