NCT03241147终止1 期
Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- AUC0-inf
研究概览
简要总结
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
详细描述
If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.
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
- •Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)
- •Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease
- •The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:
- •Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min
排除标准
- •The subject has previously been dosed with Lu AF35700
研究组 & 干预措施
Subjects with severe renal impairment (Group A)
Experimental
干预措施: Lu AF35700 (Drug)
Healthy subjects (Group B)
Experimental
干预措施: Lu AF35700 (Drug)
Subjects with moderate renal impairment (Group C)
Experimental
干预措施: Lu AF35700 (Drug)
Subjects with mild renal impairment (Group D)
Experimental
干预措施: Lu AF35700 (Drug)
结局指标
主要结局
AUC0-inf
时间窗: Predose to day 57 postdose
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity
Cmax
时间窗: Predose to day 57 postdose
Maximum observed plasma concentration of Lu AF35700
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's DiseaseHealthyAlzheimer DiseaseNCT04149860H. Lundbeck A/S86
已完成
1 期
Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's DiseaseHealthyParkinson DiseaseNCT03611569H. Lundbeck A/S74
已完成
1 期
Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With SchizophreniaSchizophreniaNCT02202226H. Lundbeck A/S96
已完成
1 期
Bioequivalence Study of Lu AF35700HealthyNCT03394482H. Lundbeck A/S87
已完成
1 期
Clinical Pharmacology Study of MT-3534 in Healthy Adult Male VolunteersHealthy Adult Male VolunteersNCT06482346Mitsubishi Tanabe Pharma Corporation56