NCT01187186已完成1 期
A Phase 1, Open-Label, Single-Dose Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the Child-Pugh Classification (CPC).
详细描述
Study drug will be orally administered on Day 1. Subjects will be admitted to the clinic until completion of clinic discharge procedures on Day 7 with an outpatient follow-up visit 6-9 days after clinic discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with Moderate Hepatic Impairment
- •Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating
- •Weights at least 45 kg
- •Body mass index between 18 and 34 kg/m2
- •Meets criteria for moderate hepatic impairment defined by Child-Pugh method
- •Subjects with Normal Hepatic Function
- •Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating
- •Weights at least 45 kg
- •Body mass index between 18 and 34 kg/m2
- •Must have normal hepatic function defined by Child-Pugh method
排除标准
- •Subjects with Moderate Hepatic Impairment
- •Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal /gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation.
- •Has severe or moderate renal dysfunction
- •Known to be human immunodeficiency virus (HIV) positive
- •Has clinically significant history or presence of illness, malignancy or immunodeficiency
- •Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in
- •Has history of alcoholism or drug/chemical/substance abuse within past 2 years
- •Subjects with Normal Hepatic Function
- •Has severe or moderate renal dysfunction
- •Known to be human immunodeficiency virus (HIV) positive
- •Has clinically significant history or presence of illness, malignancy or immunodeficiency
- •Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in
- •Has history of alcoholism or drug/chemical/substance abuse within past 2 years
研究组 & 干预措施
Moderate Hepatic Impairment
Experimental
Subjects with Moderate Hepatic Impairment
干预措施: ASP1941 (Drug)
Normal Hepatic Function
Experimental
Subjects with Normal Hepatic Function
干预措施: ASP1941 (Drug)
结局指标
主要结局
Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples
时间窗: 7 days following study drug administration
次要结局
- Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples(7 days following study drug administration)
研究者
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