Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study Of ISIS 681257 Subcutaneous Injections In Male And Female Subjects With Normal And Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evaluate the effect of ISIS 681257 following a single subcutaneous dose in subjects with impaired renal function relative to matched, healthy controls with normal renal function.
研究概览
简要总结
This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and Impaired Renal Function
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •At least 18 years old
- •BMI 18.5 to 42.0 kg/m2
- •No known diseases or significant findings on physical exam (normal renal only)
- •eGFR >/= 90 mL/min/1.73m2 (normal renal only)
- •Clinically stable (renal impaired only)
- •eGFR 30-59 mL/min/1.73m2 (renal impaired only)
排除标准
- •Females of childbearing potential
- •Conditions or disease that may interfere with study drug
- •Any significant diseases
- •Hypersensitivity to any drugs or similar drugs to those used in the study
- •Drug dependency or abuse
- •Previous exposure to other investigational drug within 28 days
- •Blood donations within 28 days
研究组 & 干预措施
Normal Renal Function
Subjects with normal renal function will be matched by age (±10 years), weight (± 20%), and gender to the pooled mean values of subjects with the moderate renal impairment. Subjects will receive 1 dose of ISIS 681257.
干预措施: ISIS 681257 (Drug)
Moderate Renal Impairment
Presence of moderate renal impairment (eGFR 30-59 mL/min/1.73m2). Subjects will receive 1 dose of ISIS 681257.
干预措施: ISIS 681257 (Drug)
结局指标
主要结局
Evaluate the effect of ISIS 681257 following a single subcutaneous dose in subjects with impaired renal function relative to matched, healthy controls with normal renal function.
时间窗: Day 31
The plasma concentrations of ISIS 681257 will be measured.
次要结局
- The plasma protein binding of ISIS 681257 in subjects with normal and impaired renal function.(Day 1)
- The incidence of adverse effects of ISIS 681257 in subjects with normal and impaired renal function.(Day 31)