A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of Tropifexor (LJN452) in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Control Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health as determined by past medical history, physical examination, ECG, laboratory tests, and urinalysis at Screening.
排除标准
- •Liver disease or liver injury
- •Chronic infection with Hepatitis B or Hepatitis C
- •History or presence of impaired renal function
- •Hepatically Impaired Subjects:
- •Inclusion Criteria:
- •Hepatic impairment as defined by the Child-Pugh classification for severity of liver disease
- •Exclusion Criteria:
- •Severe complications of liver disease within the preceding 3 months
- •Emergency room visit or hospitalization due to liver disease within the preceding 3 months for mildly and moderately hepatically impaired subjects, and within the preceding 1 month for severely hepatically impaired subjects
- •Subject has received liver transplant at any time in the past and is on immunosuppressant therapy
- •Acute Hepatitis B or Hepatitis C infection
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group 1 - Normal Hepatic Function
Normal hepatic function - Control - control group
干预措施: LJN452 (Drug)
Group 2 - Mild Hepatic Impairment
Mild hepatic impairment - Child-Pugh A (Score 5-6)
干预措施: LJN452 (Drug)
Group 3 - Moderate Hepatic Impairment
Moderate hepatic impairment - Child-Pugh B (Score 7-9)
干预措施: LJN452 (Drug)
Group 4 - Severe Hepatic Impairment
Severe hepatic impairment - Child-Pugh C (score 10-15)
干预措施: LJN452 (Drug)
结局指标
主要结局
Cmax
时间窗: Up to 8 days
The maximum (peak) observed drug concentration after single dose administration (mass x volume-1)
Tmax
时间窗: Up to 8 days
Time to reach the maximum (peak) plasma drug concentration after single dose administration (time)
AUClast
时间窗: Up to 8 days
The area under the concentration-time curve from time zero to the time of the last quantifiable concentration sampling time (mass x time x volume-1)
AUCinf
时间窗: Up to 8 days
The area under the concentration-time curve from time zero to infinity (mass x time x volume-1)
T1/2
时间窗: Up to 8 days
The elimination half-life associated with the terminal slope of a semi-logarithmic concentration-time curve
CL/F
时间窗: Up to 8 days
The apparent total body clearance of the drug from plasma (volume x time-1)
Vz/F
时间窗: Up to 8 days
The apparent volume of distribution during the terminal phase
次要结局
- fu(Day 1)
- Cmax,u(Day 1)
- AUClast,u(Day 1)
- AUCinf,u(Day 1)
- CL/F,u(Day 1)