A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- PK Assessment
研究概览
简要总结
Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.
详细描述
This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate or severe hepatic impairment or matched control
- •BMI between 18.0 and 40.0 kg/m2
排除标准
- •Evidence of acute deterioration of hepatic function within 8 weeks
- •ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes
- •Total bilirubin > 5 mg/dl for moderates; no upper limit for severes
- •Hemoglobin < 10g/dl for moderates; Hemoglobin < 9g/dl for severes
研究组 & 干预措施
Matched control
干预措施: TR-701 FA (Drug)
Moderate hepatic
干预措施: TR-701 FA (Drug)
Severe Hepatic
干预措施: TR-701 FA (Drug)
结局指标
主要结局
PK Assessment
时间窗: 7 days
PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance.
次要结局
- Safety(7 days)