NCT03289234已完成1 期
A Multi-Center, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Shionogi2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年11月16日最近更新:
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
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- AUC0-∞
研究概览
简要总结
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects
- •Able to provide written informed consent to participate in this study after reading the ICF
- •Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements.
- •A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2
- •Hepatic impaired subjects (in addition)
- •A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment
- •Chronic and stable hepatic impairment
- •Healthy subjects (in addition)
- •Subject with normal hepatic function
- •Good health and free from clinically significant illness or disease
排除标准
- •All subjects
- •Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance
- •Subjects were previously administered MCI-
- •Positive urine drug screen (if not due to concomitant medication) or alcohol test
- •History of drug abuse
- •Presence of alcohol abuse
- •Presence of active infection requiring antibiotics
- •Positive test for human immunodeficiency virus (HIV) antigen/antibody
- •Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg
- •eGFR <60 mL/min/1.73m2
- •Hepatic impairment subject (in addition)
- •Subjects with severe ascites
- •Healthy subject (in addition)
- •History or presence of any parenchymal hepatic disease
- •Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)
研究组 & 干预措施
moderate hepatic impairment
Experimental
干预措施: MCI-186 (Drug)
normal hepatic function
Experimental
干预措施: MCI-186 (Drug)
mild hepatic impairment
Experimental
干预措施: MCI-186 (Drug)
结局指标
主要结局
AUC0-∞
时间窗: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Cmax
时间窗: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
AUC0-last
时间窗: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
次要结局
- t½(pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose)
研究者
研究点 (2)
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