An Open-label, Single-dose,Intravenous Administration Study to Compare the Pharmacokinetics and Safety of ONO-2745/CNS 7056 in Subjects With Chronic Hepatic Impairment With Matching Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- To study the effect of ONO-2745/CNS 7045 on the subjects with hepatic impairment by evaluating the safety parameters per protocol including labs, vitals and adverse events
研究概览
简要总结
To evaluate and compare the pharmacokinetics and safety of ONO-2745/CNS 7056 in subjects with the hepatic impairment and matched healthy subjects.
详细描述
In Part One, 8 subjects with moderate hepatic impairment (Child Pugh Scale B) and 8 matched healthy subjects will be enrolled. In Part 2, 8 subjects with mild hepatic impairment (Child-Pugh Scale A) and 8 matched healthy subjects will be enrolled. In Part 3, 3 subjects with severe hepatic impairment (Child-Pugh Scale C) will be enrolled. Parts 2 and 3 will only be initiated if the criteria per protocol is met in Part One. The pharmacokinetics and safety profiles will be compared between hepatic impaired subjects and healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females between 18 and 65 years of age
- •Negative test for the selected drugs of abuse at screening
- •Hepatic impaired subjects:
- •Stable hepatic function and medication regimen for at least 28 days prior to check-in
- •Degree of hepatic impairment will be determined by the Child-Pugh Scale
排除标准
- •Clinical manifestation of any disease (except hepatic impaired subjects)
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, including food, or other substance
研究组 & 干预措施
Healthy subjects matched to mild hepatic impaired subjects
Single IV bolus of NO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
干预措施: ONO-2745 /CNS 7056 (Drug)
Subjects with moderate chronic hepatic impairment
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
干预措施: ONO-2745 /CNS 7056 (Drug)
Healthy subjects matched to moderate hepatic impaired subjects
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
干预措施: ONO-2745 /CNS 7056 (Drug)
Subjects with mild chronic hepatic impairment
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
干预措施: ONO-2745 /CNS 7056 (Drug)
Subjects with severe chronic hepatic impairment
Single IV bolus of ONO-2745/CNS 7056 over 1 minute at 0.1 mg/kg body weight
干预措施: ONO-2745 /CNS 7056 (Drug)
结局指标
主要结局
To study the effect of ONO-2745/CNS 7045 on the subjects with hepatic impairment by evaluating the safety parameters per protocol including labs, vitals and adverse events
时间窗: Overall safety: Pre-dose to 7 days post-dose
To study the effect of hepatic impairment on the pharmacokinetics of ONO-2745/CNS 7045 by assessment of drug concentration through blood sample analysis
时间窗: PK: Pre-dose to 4 hours post-dose
次要结局
未报告次要终点