An Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of JNJ-42847922 in Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites M12 and M16
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-42847922 in adult participants with hepatic impairment when compared to healthy participants 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a man or woman 18 to 79 years of age, inclusive Participants with normal hepatic function
- •Generally healthy
- •Must not exceed upper limit of normal limits for serum bilirubin, transaminase levels, albumin levels, prothrombin time (PT), and International Normalized Ratio (INR) when measured at screening and Day 1 Participants with (Mild, Moderate or Severe) hepatic impairment
- •Medically stable
- •Total Child-Pugh score of 5 or 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10 to 15, inclusive (severe) as determined by the investigator
- •Stable hepatic function during screening and those measured on Day 1
- •Stable renal function
排除标准
- •Participants with normal hepatic function
- •Hepatitis B surface antigen (HBsAg) or hepatitis C antibodies at screening Participants with (Mild, Moderate or Severe) hepatic impairment
- •Severe ascites or pleural effusion; prothrombin time greater than (>)18 seconds; evidence of progressive liver disease within the previous 4 weeks, as indicated by changes in hepatic transaminases, alkaline phosphatase, and gamma-glutamyl transferase
- •History of hepatopulmonary syndrome, hydrothorax, or significant hepatorenal syndrome
- •Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor
- •Clinically significant laboratory findings except as related to hepatic impairment
研究组 & 干预措施
Part 1: Cohort 1 (JNJ-42847922)
Participants with normal hepatic function will receive Dose 1 of JNJ-42847922 on Day 1.
干预措施: JNJ-42847922 (Drug)
Part 1: Cohort 2 (JNJ-42847922)
Participants with mild hepatic impairment will receive Dose 1 of JNJ-42847922 on Day 1.
干预措施: JNJ-42847922 (Drug)
Part 1: Cohort 3 (JNJ-42847922)
Participants with moderate hepatic impairment will receive Dose 2 of JNJ-42847922 on Day 1.
干预措施: JNJ-42847922 (Drug)
Part 2: Cohort 4 (Optional) (JNJ-42847922)
Participants with moderate hepatic impairment will receive Dose 1 (depending on the results of Cohort 3) of JNJ-42847922 on Day 1.
干预措施: JNJ-42847922 (Drug)
Part 2: Cohort 5 (Optional) (JNJ-42847922)
Participants with severe hepatic impairment will receive Dose 2 or Dose 3 (depending on the results of Part 1) of JNJ-42847922 on Day 1.
干预措施: JNJ-42847922 (Drug)
结局指标
主要结局
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites M12 and M16
时间窗: Pre-dose, up to 96 hours post-dose (up to Day 5)
Cmax is defined as maximum observed plasma analyte concentration of JNJ-42847922 and its metabolites M12 and M16.
Area Under Plasma Analyte Concentration versus Time Curve from Time Zero to Time of Last Measurable Concentration (AUC [0-last]) of JNJ-42847922 and its Metabolites M12 and M16
时间窗: Pre-dose, up to 96 hours post-dose (up to Day 5)
AUC(0-last) is defined as area under the plasma analyte concentration versus time curve from time zero to time of last measurable concentration of JNJ-42847922 and its metabolites M12 and M16.
Area Under the Plasma Analyte Concentration versus Time Curve from Time Zero to Infinite Time (AUC[0-Infinity]) of JNJ-42847922 and its Metabolites M12 and M16
时间窗: Pre-dose, up to 96 hours post-dose (up to Day 5)
AUC(0-infinity) is defined as the area under the plasma analyte concentration versus time curve from time zero to infinite time of JNJ-42847922 and its metabolites M12 and M16.
次要结局
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability(Up to Day 5)