NCT01392807已完成1 期
An Open-label, Single-center Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function Following Administration of a Single Dose of 25mg NKTR-118
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic 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
- Basic Science
- 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
- •Males or females aged 18 years or more with a weight of at least 50 kg and BMI between 18 and 40 kg/m2, inclusive.
- •Negative screen for human immunodeficiency virus (HIV)
- •For subjects with normal hepatic function, negative results for serum hepatitis B (HBV) surface antigen, HCV antibody, and HIV
排除标准
- •Plasma or blood product donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
- •Known or suspected history of drug/chemical abuse within the past 2 years as judged by the Investigator.
- •Subjects with a history of surgery on the gastrointestinal tract.
- •For patients with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).
研究组 & 干预措施
Group 1
Experimental
Normal hepatic function, 25 mg NKTR-118 administered orally
干预措施: NKTR-118 (Drug)
Group 2
Experimental
Mild hepatic impairment, 25 mg NKTR-118 administered orally
干预措施: NKTR-118 (Drug)
Group 3
Experimental
Moderate hepatic impairment, 25 mg NKTR-118 administered orally
干预措施: NKTR-118 (Drug)
结局指标
主要结局
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax)
时间窗: Duration from predose day 1 to day 6.
次要结局
- To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting adverse events.(Duration from day -1 to follow up. ( Approximately 15-18 days))
- To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function by collecting safety blood samples(Duration from day -1 to follow up. ( Approximately 15-18 days))
- To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting vital signs(Duration from day -1 to follow up. ( Approximately 15-18 days))
研究者
研究点 (1)
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