Interventional, Single-site, Open-label, Reduced/Staged, Multiple-dose Study Investigating the Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Patients With Renal Impairment and in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy 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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged between 50 and 75 years (inclusive)
- •BMI ≥18.5 kg/m2 and ≤32 kg/m2 at the Screening Visit.
- •Group A: Patients with severe renal impairment renal impairment (creatinine clearance (ClCr) ≤29 mL/min)
- •Group B: Healthy subjects with normal kidney function (creatinine clearance (ClCr) ≥90 mL/min, inclusive)
- •Group C: Patients with moderate renal impairment ((creatinine clearance between 30 - 59 mL/min, inclusive)
- •Group D: Patients with mild renal impairment (Creatinine clearance between 60 - 89 mL/min, inclusive)
排除标准
- •The subject has taken disallowed medication <1 week prior to the first dose of IMP or <5 half-lives prior to the first dose of IMP for any disallowed medication taken, whichever is longer)
- •Other protocol defined inclusion and exclusion criteria do apply
研究组 & 干预措施
Idalopirdine (Lu AE58054) 60 mg (Group A)
8 patients with severe renal impairment and not on dialysis
干预措施: Idalopirdine (Lu AE58054) 60 mg (Drug)
Idalopirdine (Lu AE58054) 60 mg (Group B)
8 healthy subjects
干预措施: Idalopirdine (Lu AE58054) 60 mg (Drug)
Idalopirdine (Lu AE58054) 60 mg (Group C)
Group C will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B
8 patients with moderate renal impairment
干预措施: Idalopirdine (Lu AE58054) 60 mg (Drug)
Idalopirdine (Lu AE58054) 60 mg (Group D)
Group D will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B
8 patients with mild renal impairment
干预措施: Idalopirdine (Lu AE58054) 60 mg (Drug)
结局指标
主要结局
Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)
时间窗: Day 10
Maximum observed concentration (Cmax) of Lu AE58054
时间窗: 0-12 hours day 10
次要结局
未报告次要终点