An Open-Label, Single-Dose Trial to Assess the Effects of Hepatic Impairment on the Pharmacokinetics of Obeticholic Acid (OCA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Peak plasma concentration (Cmax) of OCA and conjugates
研究概览
简要总结
This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid (OCA) in healthy volunteers and patients with liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mild Hepatic Impairment
Subjects with mild hepatic impairment defined as Child-Pugh class A receiving a single dose of obeticholic acid 10mg.
干预措施: obeticholic acid 10 mg (Drug)
Healthy Volunteer
Healthy volunteers receiving a single dose of obeticholic acid 10 mg.
干预措施: obeticholic acid 10 mg (Drug)
Moderate Hepatic Impairment
Subjects with moderate hepatic impairment defined as Child-Pugh class B receiving obeticholic acid 10mg.
干预措施: obeticholic acid 10 mg (Drug)
Severe Hepatic Impairment
Subjects with severe hepatic impairment defined as Child-Pugh class C receiving obeticholic acid 10 mg.
干预措施: obeticholic acid 10 mg (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of OCA and conjugates
时间窗: Up to 48 hours
maximum concentration
Area under the concentration versus time curve from time 0 to the last sampling time with measurable analyte concentration (AUCt) of OCA and conjugates
时间窗: Post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 216 hours post-dose
Time to Cmax (Tmax) of OCA and conjugates
时间窗: Up to 48 hours
Area under the concentration versus time curve from time 0-24 hours with measurable analyte concentration of OCA and conjugates. (AUC 0-24)
时间窗: 24 hours
次要结局
- Amount of OCA and conjugates excretion in urine(-6to 0, 0 to 6, 6 to 12, 12 to 24, and 24 to 30 hours)
- Total amount of OCA and conjugates excreted in urine(0 to 30 hours)
- Protein Binding(0, 0.75, 1.5, 6, and 24 hours)
- Urine concentration of unchanged OCA and conjugates(0, 6, 12, 24, 30 hours)