An Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-914143 in Subject With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
研究概览
简要总结
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
详细描述
Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal renal function or mild, moderate, severe or end-stage renal dysfunction
排除标准
- •History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months of Lambda administration
- •History of chronic liver disease including cirrhosis, hepatitis B virus (HBV), hepatitis C virus (HCV), primary biliary cirrhosis, etc
- •History of central nervous system or neuro-psychiatric disease. Subjects with severe depression and/or other uncontrolled psychiatric conditions should not be enrolled in this study
- •History of of suicide attempt within the 5 years preceding BMS-914143 administration
- •Inability to tolerate subcutaneous injections
- •Donation of >400 mL of blood within 8 weeks or plasma within 4 weeks of planned dosing
结局指标
主要结局
Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
时间窗: 18 time points up to Day 29
Area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration [AUC(0-T)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
时间窗: 18 time points up to Day 29
Maximum observed serum concentration (Cmax) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
时间窗: 18 time points up to Day 29
Apparent volume of distribution (Vz/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
时间窗: 18 time points up to Day 29
Total body clearance (CLT/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
时间窗: 18 time points up to Day 29
次要结局
- Time to maximum observed serum concentration (Tmax) using serum levels of Lambda(18 time points up to Day 29)
- Half life (T-HALF) using serum levels of Lambda(18 time points up to Day 29)
- Immunogenicity assessed by serum levels of anti-Lambda antibodies(5 time points up to Day 43)
- Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)(Up to Day 43)
- Serious adverse events (SAEs) Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)(Approximately up to Day 73)