A Phase I, Open-Label, Parallel-Group, Single-Dose Study to Assess the Pharmacokinetics of XL184 (Cabozantinib) Capsules in Hepatic Impaired Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Exelixis
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- AUC, Cmax, tmax, t1/2, CL/F, and V/F parameters as a measure of the PK of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects compared to healthy adult subjects matched for age, gender, body mass index (BMI), and ethnicity
研究概览
简要总结
The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects. Another objective is to assess the safety and tolerability of cabozantinib in these adult subjects.
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
- •Body weight must be ≥50 kg and <130 kg with a BMI of ≥18 (kg/m2) and ≤36.0 (kg/m2).
- •Must use acceptable forms of birth control during the course of the study and for 3 months following the single dose of study drug.
- •Female subjects of childbearing potential must have a negative pregnancy test at screening and check-in.
- •Must have adequate vital sign reads at screening and check-in.
- •Must be able to comply with dietary and fluid restrictions required for the study
排除标准
- 未提供
研究组 & 干预措施
Group 1
Subjects with normal hepatic function: healthy normal adult subjects
干预措施: cabozantinib (Drug)
Group 2
Subjects with mild hepatic impairment: adult subjects with a Child-Pugh grade A (score 5-6).
干预措施: cabozantinib (Drug)
Group 3
Moderate hepatic impairment: adult subjects with a Child-Pugh grade B (score 7-9).
干预措施: cabozantinib (Drug)
Group 4
Severe hepatic impairment: adult subjects with a Child-Pugh grade C (score 10-15).
干预措施: cabozantinib (Drug)
结局指标
主要结局
AUC, Cmax, tmax, t1/2, CL/F, and V/F parameters as a measure of the PK of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects compared to healthy adult subjects matched for age, gender, body mass index (BMI), and ethnicity
时间窗: Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22
Subjects will receive a single oral 75 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 through 5 following this single dose, as well as on the mornings of Days 6, 8, 11, 15, 19, 21, and 22.
次要结局
- Number of participants with adverse events, serious adverse events, and laboratory abnormalities as a measure of the safety and tolerability of a single oral 75 mg dose in hepatic impaired adult subjects and healthy adult subjects(Days 1 - 5, 6, 8, 11, 15, 19, 21, and 22)