A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of JNJ-56136379
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Plasma Concentration of JNJ-56136379
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in participants with liver cirrhosis and impaired hepatic function when compared with healthy participants with normal hepatic function and no liver cirrhosis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of / or current clinically significant medical illness that could interfere with the interpretation of the study results.
- •Known allergies, hypersensitivity, or intolerance to JNJ-6379 or its excipients.
- •History of drug or alcohol abuse within 1 year before screening or positive test results at screening and Day -
- •Blood or blood products donated or substantial loss of blood (more than 500 milliliters [mL]) within 3 months before the study starts
- •Experimental drug received (including investigational vaccines) or experimental medical device used within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study intervention is scheduled.
- •Evidence of infection with human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis A, B or C (except if sustained virologic response to hepatitis C virus [HCV] treatment).
- •Inability to fast for 10 hours.
- •Signs of hepatocellular carcinoma or history of biliary obstruction within the past 2 years.
- •Lack of good or reasonable venous access.
研究组 & 干预措施
Part A: Group 1
Participants with liver cirrhosis with moderate hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
干预措施: JNJ-56136379 (Drug)
Part A: Group 2
Participants with normal liver function with no liver cirrhosis will receive a single oral dose of JNJ-56136379 in fed condition.
干预措施: JNJ-56136379 (Drug)
Part B: Group 3 (optional)
Participants with liver cirrhosis with mild hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
干预措施: JNJ-56136379 (Drug)
Part B: Group 4 (optional)
Participants with liver cirrhosis with severe hepatic impairment will receive a single oral dose of JNJ-56136379 in fed condition.
干预措施: JNJ-56136379 (Drug)
结局指标
主要结局
Plasma Concentration of JNJ-56136379
时间窗: Up to Day 21
Plasma concentration of oral dose of JNJ-56136379 will be assessed.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 6 months)