A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of Apalutamide in Subjects With Severe Hepatic Impairment Compared With Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide
研究概览
简要总结
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants must not have hepatic encephalopathy greater than or equal to (>=) Grade 3 (for participants with severe hepatic impairment) 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
- •Participants with normal hepatic function must be in good health with no clinically significant findings from medical history, physical examination, vital signs, and laboratory evaluation, unless deemed not clinically significant by the investigator
- •Participants with normal hepatic function must have serum creatinine within normal limits and Creatinine Clearance (CrCL) greater than (>) 60 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) as calculated per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
- •Participants with severe hepatic impairment must have a total Child-Pugh score of 10 to 15 inclusive, as determined by the investigator during screening and on Day -1 prior to study drug administration. Source documents to substantiate the clinical diagnosis (for example, ultrasonography, liver biopsy, liver/spleen scan, laboratory results or clinical findings), and medical history will be reviewed and signed by the investigator
- •Participants with severe hepatic impairment must have CrCL >= 45 mL/min/1.73 m^2 as calculated per CKD-EPI Creatinine Equation
排除标准
- •Use of thyroid hormone replacement therapy
- •Participants with normal hepatic function with presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function
- •Participants with normal hepatic function who have Hepatitis A immunoglobulin M positivity, Hepatitis B surface antigen (HBsAg) positivity, positive serology for Hepatitis B or Hepatitis C antibodies. Hepatitis B surface antibody positivity is not exclusionary if participant can provide evidence of Hepatitis B vaccination
- •Participants with severe hepatic impairment who have 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
- •Participants with severe hepatic impairment previously diagnosed with hepatocellular carcinoma
研究组 & 干预措施
Group 1: Participants with Severe Hepatic Impairment
Participants with severe hepatic impairment will receive single oral dose of apalutamide on Day 1 under fasted condition.
干预措施: Apalutamide (Drug)
Group 2: Participants with Normal Hepatic Function
Participants with normal hepatic function will receive single oral dose of apalutamide on Day 1 under fasted condition.
干预措施: Apalutamide (Drug)
结局指标
主要结局
Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide
时间窗: Up to Day 57
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Area Under Concentration-time Curve from Time 0 to the Time of the Last Concentration (AUC[0-last]) of Apalutamide
时间窗: Up to Day 57
AUC(0-last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of apalutamide calculated by linear-linear trapezoidal summation.
Peak Plasma Concentration (Cmax) of Apalutamide
时间窗: Up to Day 57
Cmax is defined as peak observed plasma concentration of the drug.
次要结局
- Number of Participants with Adverse Event as a Measure of Safety and Tolerability(Up to 78 days)