Single Dose Pharmacokinetics and Safety of Daclatasvir in Subjects With Renal Function Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir
研究概览
简要总结
The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.
详细描述
Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet renal function criteria in one of four categories
排除标准
- •Unstable or uncontrolled medical conditions
研究组 & 干预措施
Group A (Normal renal function): Daclatasvir
Daclatasvir 60 mg tablet by mouth single dose on Day 1
干预措施: Daclatasvir (Drug)
Group B (End Stage Renal Disease): Daclatasvir
Daclatasvir 60 mg tablet by mouth single dose on Day 1
干预措施: Daclatasvir (Drug)
Group C (Moderate renal impairment): Daclatasvir
Daclatasvir 60 mg tablet by mouth single dose on Day 1
干预措施: Daclatasvir (Drug)
Group D (Severe renal impairment): Daclatasvir
Daclatasvir 60 mg tablet by mouth single dose on Day 1
干预措施: Daclatasvir (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir
时间窗: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.
次要结局
- Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Percent Urinary Recovery (%UR) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events(Baseline up to Day 5 post dose)
- Maximum Observed Plasma Concentration (Cmax) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Unbound Maximum Observed Plasma Concentrations of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Plasma Half-life (T-half) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Renal Clearance (CLR) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Apparent Volume of Distribution (Vd/F) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Apparent Total Body Clearance (CLT/F) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Unbound Apparent Clearance (CLU/F) of Daclatasvir(Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose)
- Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died(First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs)
- Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events(Baseline up to Day 5 post dose)
- Number of Participants With Out-of-range Vital Signs Reported as Adverse Events(Baseline up to Day 5 post dose)