A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LC350189 in Subjects With Varying Degrees of Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- AUC from time 0 to the last quantifiable concentration
研究概览
简要总结
This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A: Normal (control) renal function
干预措施: LC350189 200 mg (Drug)
B: Mild impairment renal function
干预措施: LC350189 200 mg (Drug)
C: Moderate impairment renal function
干预措施: LC350189 200 mg (Drug)
D: Severe impairment renal function
干预措施: LC350189 200 mg (Drug)
结局指标
主要结局
AUC from time 0 to the last quantifiable concentration
时间窗: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
AUC from time 0 to 24 hours post dose
时间窗: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
AUC from time 0 to the end of the dosing interval at steady state
时间窗: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Maximum observed plasma concentration
时间窗: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Maximum observed plasma concentration at steady state
时间窗: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Time to reach maximum observed plasma concentration
时间窗: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Time to reach maximum observed plasma concentration at steady state
时间窗: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Amount of drug excreted in urine (Ae) over each collection interval
时间窗: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
次要结局
- Serum mean concentration over 24 hours(Before dosing on Days 1 through Day 8)
- Maximum observed effect(Before dosing on Days 1 through Day 8)
- Time to reach maximum effect(Before dosing on Days 1 through Day 8)
- Incidence of adverse events(Days 1 through Day 9 (end of study))