NCT01208285已完成1 期
A Phase 1 Non-Randomized, Open-Label Study to Assess the Safety and Pharmacokinetics of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
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
- 24
- 主要终点
- VX-770 pharmacokinetic parameters
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Group A (Subjects with Hepatic Impairment):
- •male or female between 18 and 65 years of age
- •subjects must have a Child-Pugh total score of 7 to 9
- •subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study
- •subjects must have a body mass index (BMI) of 18 to 35 kg/m2
- •Group B (Healthy Subjects):
- •male or female between 18 and 65 years of age
- •subjects will match subjects with hepatic impairment for sex, BMI, cigarette smoking habit, and age
- •subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study
排除标准
- •Group A (Subjects with Hepatic Impairment):
- •subjects who are not clinically stable or who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- •subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of CYP3A
- •subjects who have a history of alcohol abuse within 1 year or illicit drug abuse within 2 years
- •subjects who smoke more than 10 cigarettes per day
- •subjects who have fluctuating or rapidly deteriorating hepatic function
- •subjects who have significant renal dysfunction
- •subjects who have HIV, or active hepatitis B
- •subjects who have previous solid organ or bone marrow transplantation
- •Group B (Healthy Subjects):
- •subjects who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
- •subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of CYP3A
- •subjects who have a history of alcohol or illicit drug abuse within 2 years
- •subjects who smoke more than 10 cigarettes per day
- •subjects who have HIV, hepatitis C, or active hepatitis B
研究组 & 干预措施
Group A
Experimental
approximately 12 male and female subjects with moderate hepatic impairment
干预措施: VX-770 (Drug)
Group B
Experimental
approximately 12 healthy male and female subjects
干预措施: VX-770 (Drug)
结局指标
主要结局
VX-770 pharmacokinetic parameters
时间窗: 4 or 10 Days
次要结局
- VX-770 metabolites pharmacokinetic parameters(4 or 10 days)
- Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs(up to 40 days)
研究者
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