A Phase 1, Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of JNJ-73763989
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-73763989
研究概览
简要总结
The purpose of the study is to evaluate the single-dose pharmacokinetic (PK) of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in participants with liver cirrhosis and various degrees of 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-3989 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 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
- •Use of any disallowed therapies as per protocol
- •Participants with advanced renal disease with staggered estimated glomerular filtration rate (eGFR) cutoff for increasing degree of hepatic impairment
- •History of Liver transplant, gastroesophageal variceal bleeding within 6 months prior to screening, known gastric varices, uncontrolled ascites, spontaneous bacterial peritonitis within 3 months before screening
- •Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function or use of any therapy known to exacerbate hepatic dysfunction within 2 weeks of study intervention administration
- •Clinically significant laboratory findings except as related to hepatic impairment as defined per protocol
研究组 & 干预措施
Part A: Group 1
Participants with liver cirrhosis with moderate hepatic impairment will receive single subcutaneous (SC) injection of JNJ-73763989 on Day 1 under fasted condition.
干预措施: JNJ-73763989 (Drug)
Part A: Group 2
Participants with normal liver function with no liver cirrhosis will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.
干预措施: JNJ-73763989 (Drug)
Part B: Group 3 (optional)
Participants with liver cirrhosis with mild hepatic impairment will receive single SC injection of JNJ-73763989 on Day 1 under fasted condition.
干预措施: JNJ-73763989 (Drug)
Part B: Group 4 (optional)
Participants with liver cirrhosis with severe hepatic impairment will receive SC injection of JNJ-73763989 on Day 1 under fasted condition.
干预措施: JNJ-73763989 (Drug)
结局指标
主要结局
Plasma Concentration of JNJ-73763989
时间窗: Up to Day 4
Plasma concentration of oral dose of JNJ-73763989 will be reported.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 42 days)