A Non-Randomized, Open-Label, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics of GBT440 in Subjects With Renal Impaired Function to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
研究概览
简要总结
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function.
详细描述
Up to 40 adult subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •All subjects:
- •Males or females, 18 to 80 years old
- •Willing and able to give written informed consent
- •Subjects with renal impairment:
- •Severe renal impairment (eGFR < 30 mL/min/1.73m2, not on dialysis)
- •Moderate renal impairment (30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2)
- •Mild renal impairment (60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2)
- •Healthy subjects:
- •Match in age, gender and body mass index with renal impaired subjects
- •Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history
排除标准
- •All subjects:
- •Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device)
- •Any signs or symptoms of acute illness at screening or Day -1
- •History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- •Subjects with renal impairment:
- •History of clinically significant hepatic disease e.g. hepatitis, cirrhosis and or liver enzymes (ALT, AST, GGT and total bilirubin) > 5 times the upper limit of normal within the past year
研究组 & 干预措施
GBT440 Dose 1: Severe Renal Impairment
eGFR < 30 mL/min/1.73m2, not on dialysis
干预措施: GBT440 (Drug)
GBT440 Dose 1: Moderate Renal Impairment
30 mL/min/1.73m2 = or < eGFR < 60 mL/min/1.73m2
干预措施: GBT440 (Drug)
GBT440 Dose 1: Mild Renal Impairment
60 mL/min/1.73m2 = or < eGFR < 90 mL/min/1.73m2
干预措施: GBT440 (Drug)
GBT440 Dose 1: Normal Renal function
eGFR > or = 90 mL/min/1.73m2
干预措施: GBT440 (Drug)
结局指标
主要结局
Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
时间窗: 28 days max
Maximum observed plasma concentration
Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
时间窗: 28 days max
AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
时间窗: 28 days max
T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
时间窗: 28 days max
次要结局
- Number of subjects with treatment-related Adverse events(28 days max)