NCT01886599已完成1 期
Open-Label, Parallel Group, Multiple-Dose Study to Evaluate the Pharmacokinetics and Safety of Asunaprevir in Subjects With Renal Function Impairment
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年11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
- 48
- 试验地点
- 3
- 主要终点
- AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7
研究概览
简要总结
The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
详细描述
Primary Purpose:
Other: The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group A: Subjects with normal renal function
- •Group B: Patients with end stage renal disease
- •Group C: Patients with mild renal impairment
- •Group D: Patients with moderate renal impairment
- •Group E: Patients with severe renal impairment
排除标准
- •History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease
- •Hepatitis B or C
- •Human Immunodeficiency Virus (HIV)
- •Recent gastrointestinal disease
研究组 & 干预措施
Arm A: Subjects with normal renal function
Experimental
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
干预措施: Asunaprevir (Drug)
Arm B: Subjects with end stage renal disease
Experimental
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
干预措施: Asunaprevir (Drug)
Arm C: Subjects with mild renal impairment
Experimental
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
干预措施: Asunaprevir (Drug)
Arm D: Subjects with moderate renal impairment
Experimental
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
干预措施: Asunaprevir (Drug)
Arm E: Subjects with severe renal impairment
Experimental
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
干预措施: Asunaprevir (Drug)
结局指标
主要结局
AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7
时间窗: 11 time points on Day 7
Area under the concentration-time curve in one dosing interval \[AUC(TAU)\] will be calculated from the blood drug concentration versus time curve
次要结局
- Plasma protein binding (PB) of Asunaprevir will be determined from the 1 hour and 3 hour time points post-dose(1 and 3 hours of Day 7)
- Maximum observed plasma concentration (Cmax) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Time of maximum observed plasma concentration (Tmax) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Minimum observed plasma concentration at Pre-AM dose (Ctrough) of Asunaprevir(3 time points up to Day 7 (blood) and 2 time points on Days 1 and 7 (urine))
- Unbound area under the concentration-time curve in one dosing interval [AUC(TAU)u] of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Area under the concentration-time curve till time of last sampling [AUC(0-T)] of Asunaprevir(11 (blood) and 2 (urine) time points on Day 7)
- Terminal elimination half life (T-Half) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Percent urinary recovery (%UR) of Asunaprevir(3 time points up to Day 7 (urine))
- Apparent total body clearance (CLT/F) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Unbound apparent clearance (CLU/F) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Renal clearance (CLR) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Apparent volume of distribution (Vd/F) of Asunaprevir(30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine))
- Accumulation index (AI): Ratio of AUC(TAU) on Day 7 to AUC(TAU) on Day 1(22 (blood) and 3 (urine) time points on Days 1 and 7)
- Safety and tolerability endpoints include all AEs and serious AEs, clinical laboratory tests, ECGs, vital signs and physical examination results(Up to Day 15 and until 30 days post discontinuation of dosing)
研究者
研究点 (3)
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