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A Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Participants With Mild or Moderate Hepatic Impairment Compared With Participants With Normal Hepatic Function

2019年5月17日 更新者：Aragon Pharmaceuticals, Inc.

A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Subjects With Mild or Moderate Hepatic Impairment Compared With Subjects With Normal Hepatic Function

The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is an open-label (all people know the identity of the intervention), single-dose, single-center, non-randomized study of JNJ-56021927 in participants who either have hepatic impairment or qualify for the control group. The study consists of 3 Phases: Screening Phase (21 Days), open-label treatment Phase (8 Days) and follow up Phase (49 Days). The duration of participation in the study for each participant is approximately 78 Days. Primarily the pharmacokinetics of JNJ-56021927 will be measured. Participants' safety will be monitored throughout the study.

研究类型

介入性

注册 (实际的)

24

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Tennessee
      • Knoxville、Tennessee、美国
    • Texas
      • San Antonio、Texas、美国

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during Screening and those measured within 24 hours prior to study drug administration
  • Sign an informed consent document indicating that the participant understands the purpose of and procedures required for the study and are willing to participate in the study. Participants must not have hepatic encephalopathy greater than or equal to (>=) Grade 3 where the participant lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted
  • Willing and able to adhere to the prohibitions and restrictions as specified in the protocol
  • If a man is sexually active with a woman of childbearing potential and has not had a vasectomy, he must agree to use an adequate contraception method as deemed appropriate by the Investigator, always use a condom during sexual intercourse, and agree to not donate sperm during the study and for 3 months after receiving the study drug
  • Body mass index (BMI) between 18 and 35 kilogram (kg)/meter (m)^2 (inclusive), and body weight not less than 50 kg
  • The participant must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); the investigator will determine hepatic impairment

Exclusion Criteria:

  • Screening thyroid-stimulating hormone (TSH) level greater than (>) Upper Limit of Normal (ULN), or participants with known history of thyroid disorders
  • Participant who is on thyroid replacement therapy
  • History of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before Screening or positive test result(s) for drugs of abuse (that is, opiates, barbiturates, benzodiazepines, cocaine, cannabinoids, and amphetamines) at Screening or Day -1. A positive test for participants with prescriptions for drugs that may interfere with the drug screen (that is, opiates and benzodiazepines) may be allowed
  • Known allergy to the study drug or any of the excipients of the formulation
  • Intention to donate blood or blood products during the study or for 3 months after the administration of the study drug
  • A man who plans to father a child while enrolled in the study or for 3 months after receiving the study drug
  • Known history of seizure or condition that may predispose to seizure or on medication that lowers seizure threshold
  • History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
  • Gall bladder (example, cholecystitis and cholelithiasis) or biliary tract disease
  • Clinically significant renal laboratory findings including serum creatinine level greater than (>) 1.5 times ULN
  • Inability to fast for 12 hours
  • History of or current clinically significant medical illness
  • Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：JNJ-56021927
Participants with mild and moderate hepatic impairment and with normal hepatic function will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.
药品：JNJ-56021927
Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Maximum Plasma Concentration (Cmax) of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The Cmax is the maximum observed plasma concentration of JNJ-56021927.
Pre-dose up to 1344 hours post-dose
Maximum Plasma Concentration Corrected for Unbound Fraction (Cmax_unb) of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The Cmax_unb is the maximum observed plasma concentration corrected for unbound fraction of JNJ-56021927.
Pre-dose up to 1344 hours post-dose
Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The Tmax is the time to reach the maximum observed plasma concentration of JNJ-56021927.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The AUC(0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to 168 Hours (AUC[0-168]) Post Dose of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The AUC(0-168hrs) is the area under the plasma concentration-time curve from 0 to 168 hours post dosing.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC[0-last]) Post Dose of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration Corrected for Unbound Fraction (AUC[last_unb]) Post Dose of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The AUC(last_unb) corrected for unbound fraction is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The AUC (0-infinity) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time Corrected for Unbound Fraction (AUC[infinity_unb]) Post Dose of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The AUC(infinity_unb) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time corrected for unbound fraction, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Pre-dose up to 1344 hours post-dose
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
大体时间：Pre-dose up to 1344 hours post-dose
The %AUC[infinity,ex] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
Pre-dose up to 1344 hours post-dose
Terminal Half-life (t[1/2]) of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Pre-dose up to 1344 hours post-dose
Elimination Rate Constant (Lambda [z]) of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The Lambda (z) determined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Pre-dose up to 1344 hours post-dose
Time of Last Measurable Plasma Concentration (Tlast) of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
Time to last measurable plasma concentration is evaluated.
Pre-dose up to 1344 hours post-dose
Total Apparent Clearance (CL/F) of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The CL/F is defined as Dose/AUC (0-infinity).
Pre-dose up to 1344 hours post-dose
Apparent Volume of Distribution (Vd/F) of JNJ-56021927
大体时间：Pre-dose up to 1344 hours post-dose
The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
大体时间：Pre-dose up to 1344 hours post-dose
The (MPR Cmax) is metabolite to parent drug ratio for maximum observed plasma concentration.
Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Quantifiable Concentration (MPR AUC[0-last])
大体时间：Pre-dose up to 1344 hours post-dose
The MPR AUClast is metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC [0-last]).
Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (MPR AUC [0-infinity])
大体时间：Pre-dose up to 1344 hours post-dose
The MPR AUC [0-infinity] is metabolite to parent drug ratio for area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUC [0-infinity]).
Pre-dose up to 1344 hours post-dose

次要结果测量

结果测量
措施说明
大体时间
Number of Participants with Adverse Events (AEs) and Serious AEs
大体时间：Screening up to follow-up (56 days after dose administration)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Screening up to follow-up (56 days after dose administration)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Aragon Pharmaceuticals, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年8月13日

初级完成 (实际的)

2017年2月9日

研究完成 (实际的)

2017年2月9日

研究注册日期

首次提交

2015年8月13日

首先提交符合 QC 标准的

2015年8月13日

首次发布 (估计)

2015年8月17日

研究记录更新

最后更新发布 (实际的)

2019年5月21日

上次提交的符合 QC 标准的更新

2019年5月17日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CR107774
  • 56021927PCR1018 (其他标识符：Janssen Research & Development, LLC)

药物和器械信息、研究文件

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

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赞助者/合作者

地点

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