A Phase 1, Open-label Study to Evaluate the Effect of Lapatinib, a BCRP Inhibitor, on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease Receiving Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- t1/2 (elimination half-life)
研究概览
简要总结
Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP) inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and tolerability of JTZ-951 when administered alone and one hour after the administration of lapatinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with end stage renal disease on hemodialysis
- •Post-dialysis body weight >45.0 kg
- •BMI between 18.0 and 40.0 kg/m2 (inclusive)
排除标准
- •Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody
- •Subjects with known history of liver failure or liver surgery
- •Subjects with a history or current clinically significant chronic or acute blood loss
研究组 & 干预措施
Experimental: JTZ-951 and Lapatinib
Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5
干预措施: JTZ-951 (Drug)
Experimental: JTZ-951 and Lapatinib
Tablets; JTZ-951, single dose on non-dialysis Days 1 and 5; Lapatinib, single dose on non-dialysis Day 5
干预措施: Lapatinib (Drug)
结局指标
主要结局
t1/2 (elimination half-life)
时间窗: 10 days
Cmax (maximum concentration)
时间窗: 10 days
AUC (area under the concentration-time curve)
时间窗: 10 days
Number of adverse events
时间窗: 10 days
tmax (time to reach maximum concentration)
时间窗: 10 days
次要结局
未报告次要终点