A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- 24-h Area under the Curve at steady state (AUCt,ss)
研究概览
简要总结
A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 22 and 40 kg/m²
- •Subjects meeting pre-defined estimated glomerular filtration rate criteria and creatinine clearance rate
- •Normal (≥90 mL/min/1.73 m2)
- •Mild (60-89 mL/min/1.73 m2)
- •Moderate (45-59 mL/min/1.73 m2)
- •Moderate (>30-44 mL/min/1.73 m2)
排除标准
- •History of acute metabolic complications
- •Uncontrolled Hypertension
- •History of Hypersensitivity to Exenatide
- •Cardiovascular Disease
- •History of Acute or chronic pancreatitis
- •Personal or family history of Multiple endocrine neoplasia type 2
- •History of Medullary thyroid cancer
- •Severe renal failure, End stage renal disease or dialysis
研究组 & 干预措施
Group 1: Normal
Normal Subjects estimated creatinine clearance (eGFR) ≥90 mL/min/1.73 m2
干预措施: ITCA 650 (Exenatide in osmotic mini pump) (Drug)
Group 2: Mild Renal Dysfunction
Subjects with Mild Renal Dysfunction estimated creatinine clearance (eGFR) 60-89 mL/min/1.73 m2
干预措施: ITCA 650 (Exenatide in osmotic mini pump) (Drug)
Goup 3: Moderate Renal Dysfunction
Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) 45-59 mL/min/1.73 m2
干预措施: ITCA 650 (Exenatide in osmotic mini pump) (Drug)
Group 4: Moderate Renal Dysfunction
Subjects with Moderate Renal Dysfunction estimated creatinine clearance (eGFR) >30-44 mL/min/1.73 m2
干预措施: ITCA 650 (Exenatide in osmotic mini pump) (Drug)
结局指标
主要结局
24-h Area under the Curve at steady state (AUCt,ss)
时间窗: Approximately 67 Days
次要结局
- Safety laboratory parameters(Approximately 67 Days)
- Vital signs(Approximately 67 Days)
- Severity of adverse events(Approximately 67 Days)
- Rate of adverse events(Approximately 67 Days)
- Physical exam(Approximately 67 Days)
- Electrocardiogram(Approximately 67 Days)