A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Pharmacokinetics of JNJ-53718678
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])
研究概览
简要总结
The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta-HCG]) test at screening and on Day -1 of the treatment period
- •Contraceptive use by female participants or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- •If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 30 days after receiving the study drug
- •A male participant must agree not to donate sperm for the purpose of reproduction from Day -1 of the study and for a minimum of 90 days after receiving the study drug
- •For participants with mild, moderate or severe hepatic impairment: the participants must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); or 10-15, inclusive (severe). The Investigator will determine degree of hepatic impairment
排除标准
- •Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients
- •Donated blood or blood products or had substantial loss of blood (more than 500 milliliter [mL]) within 90 days before the administration of study drug or intention to donate blood or blood products during the study
- •Received an experimental drug (including investigational vaccines) or used an experimental medical device within 30 days or within a period less than 5 times the drug's half-life, whichever is longer, before the dose of the study drug is scheduled
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
- •Preplanned surgery or procedures that would interfere with the conduct of the study
研究组 & 干预措施
Group 1: Participants with Mild Hepatic Impairment
Participants with mild hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
干预措施: JNJ-53718678 (Drug)
Group 2: Participants with Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
干预措施: JNJ-53718678 (Drug)
Group 3: Participants with Severe Hepatic Impairment
Participants with severe hepatic impairment will receive a single oral dose of JNJ-53718678 suspension on Day 1.
干预措施: JNJ-53718678 (Drug)
Group 4: Participants with Normal Hepatic Function
Participants with normal hepatic function will receive a single oral dose of JNJ-53718678 suspension on Day 1.
干预措施: JNJ-53718678 (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity])
时间窗: Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
AUC(0-infinity) is defined as the area under the plasma concentration-time curve from time 0 to infinite time calculated as the sum of AUClast and Clast/lz, in which Clast is the last observed quantifiable concentration.
Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of JNJ-53718678
时间窗: Predose, 15 min, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
AUClast is defined as the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of JNJ-53718678.
Maximum Plasma Concentration (Cmax) of JNJ-53718678
时间窗: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h postdose
Cmax is defined as the maximum plasma concentration of JNJ-53718678.
次要结局
- Number of Participants with Adverse Events (AEs)(From screening up to Day 14 (Up to 42 days))