An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of Elinogrel and Its Metabolite in Patients With Mild, Moderate, and Severe Renal Impairment Compared to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of elinogrel and its metabolite
研究概览
简要总结
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.
详细描述
Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects.
- mild renal impairment: CrCl from 50 to ≤80 ml/min
- moderate renal impairment: CrCl from 30 to <50 ml/min
- severe renal impairment: CrCl of <30 ml/min
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
- •Able to understand and sign the written informed consent
- •Subjects should have either normal renal function or have stable renal disease
排除标准
- •History of heart disease
- •Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
研究组 & 干预措施
E-Patients with severe renal impairment
干预措施: Elinogrel (Drug)
A-Patients with mild renal impairment
干预措施: Elinogrel (Drug)
B-Healthy subjects matched to Group A
干预措施: Elinogrel (Drug)
C-Patients with moderate renal impairment
干预措施: Elinogrel (Drug)
D-Healthy subjects matched to Group C
干预措施: Elinogrel (Drug)
F-Healthy subjects matched to Group E
干预措施: Elinogrel (Drug)
结局指标
主要结局
Pharmacokinetics of elinogrel and its metabolite
时间窗: 7 days
The PK parameters calculated for both elinogrel and PRT060301 were: * AUC0-12h, Cmax, and Tmax on Day 1/Day 7 and T1/2, RACC \& CLR on Day 7 * For elinogrel only, CLss/F and Vss/F were also calculated
次要结局
- Measures of platelet function(7 days)
- Safety assessments will include vital signs, electrocardiograms and adverse events(9 days)