A Phase 1, Pharmacokinetic and Pharmacodynamic Study of AR882 in Adult Volunteers With Various Degrees of Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
研究概览
简要总结
This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Subjects:
- •Males and non-pregnant, non-lactating females
- •Body weight no less than 50 kg
- •sUA greater than or equal to 4.0 mg/dL
- •Renal Impaired Subjects:
- •History of chronic renal impairment (> 6 months)
排除标准
- •All Subjects:
- •Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- •History of cardiac abnormalities
- •Active peptic ulcer disease or active liver disease
- •History of kidney stones
- •Renal Impaired Subjects:
- •Requires dialysis
研究组 & 干预措施
Renal Impairment
Subjects with various degrees of renal impairment
干预措施: AR882 Single Dose (Drug)
Renal Impairment
Subjects with various degrees of renal impairment
干预措施: AR882 Multiple Dose (Drug)
Normal Renal Function
Subjects with normal renal function
干预措施: AR882 Single Dose (Drug)
Normal Renal Function
Subjects with normal renal function
干预措施: AR882 Multiple Dose (Drug)
结局指标
主要结局
Area under the curve (AUC) for plasma following a single dose of AR882 in subjects with renal impairment and normal renal function
时间窗: 6 days
Time to maximum plasma concentration (Tmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
时间窗: 6 days
Maximum plasma concentration (Cmax) following a single dose of AR882 in subjects with renal impairment and normal renal function
时间窗: 6 days
Terminal half-life (t 1/2) following a single dose of AR882 in subjects with renal impairment and normal renal function
时间窗: 6 days
Amount excreted (Ae) into urine following a single dose of AR882 in subjects with renal impairment and normal renal function
时间窗: 6 days
Renal clearance (CLr) following a single dose of AR882 in subjects with renal impairment and normal renal function
时间窗: 6 days
AUC for plasma following multiple doses of AR882 in subjects with renal impairment and normal renal function
时间窗: 15 days
Tmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
时间窗: 15 days
Cmax following multiple doses of AR882 in subjects with renal impairment and normal renal function
时间窗: 15 days
t 1/2 following multiple doses of AR882 in subjects with renal impairment and normal renal function
时间窗: 15 days
次要结局
- Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following a single dose of AR882 in subjects with renal impairment and normal renal function(14 days)
- Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs following multiple doses of AR882 in subjects with renal impairment and normal renal function(21 days)