A Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Exelixis
- 入组人数
- 32
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The main objective of the trial is to compare the pharmacokinetics of a 60 mg dose of cabozantinib in adult subjects with impaired renal function compared with 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 80 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 ≤ 38.0 (kg/m2).
- •Must use acceptable form 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.
- •Negative test for HIV; hepatitis A, B, and C.
- •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
- •History of medical or surgical conditions that would interfere with GI absorption, distribution, metabolism, or excretion of the study drug.
- •Recent clinical evidence of pancreatic injury.
- •Recent use of drugs known to significantly inhibit or induce P450 CYP3A4 enzymes.
- •Previous diagnosis of malignancy.
- •Unwilling to forgo use of any over-the-counter or non-prescription preparations.
研究组 & 干预措施
Group 1
Subjects with normal renal function: healthy normal adult subjects with an eGFR ≥ 90 mL/min/1.73m2.
干预措施: cabozantinib (Drug)
Group 2
Subjects with mild renal impairment: adult subjects with a eCFR ≥ 90 mL/min/1.73m2.
干预措施: cabozantinib (Drug)
Group 3
Moderate renal impairment: adult subjects with an eGFR between ≥30 - ≤ 59 mL/min/1.73m2.
干预措施: cabozantinib (Drug)
Group 4
Severe renal impairment: adult subjects with an eGFR ≤ 29 mL/min/1.73m2, not on dialysis.
干预措施: cabozantinib (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: Days 1 - 8 as well as the morning of Days 11, 13, 15, 18, 21, 22.
AUC, Cmax, tmax, kel, t1/2, CL/F, V/F and fu as measure of a single oral 60 mg dose of cabozantinib in adults with impaired renal function compared with healthy subjects matched for age, gender, and body mass index (BMI). Subjects will receive a single oral 60 mg dose of cabozantinib on Day 1 and then undergo periodic assessments Days 1 - 8 following this single dose, as well as on the mornings of Days 11, 13, 15, 18, 21, 22.
次要结局
- Safety and Tolerability(Days 1 - 8 and Days 11, 13, 15, 18, 21, 22.)