NCT00715702已完成1 期
An Open-Label, Single-Centre, Parallel Group, Phase I Study To Compare the Pharmacokinetics of AZD5672 Single Dose in Patients With Renal Impairment and Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PK variables
研究概览
简要总结
The purpose of the study is to investigate the pharmacokinetics of a single dose of AZD5672 in patients with renal impairment by comparing with healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed written informed consent.
- •Females should not be of childbearing potential
- •Subjects classified as renally impaired should have been stable (in the Investigator's opinion) for at least 3 months prior to Visit 1.
排除标准
- •Patients taking prescription of medications: Pgp substrates, inhibitors and /or inducers, medications that affect creatinine clearance(within 7 days of dosing), atorvastatin >20mg once daily, medications that prolong QT/QTc interval
- •Change in dose regimen of prescribed medication and NSAIDs within the 2 weeks before enrolment (renal patients only)
- •Participation in another clinical study involving administration of an investigational product in the 3 months prior to treatment (or within 5 half-lives of the last dose of the investigational product, whichever is longer)
研究组 & 干预措施
1
Experimental
Patients with Moderate renal impairment and matched volunteers
干预措施: AZD5672 (Drug)
2
Experimental
Patients with Mild or Severe renal impairment and matched volunteers. Type of patient group determined after safety review of 1st group data
干预措施: AZD5672 (Drug)
结局指标
主要结局
PK variables
时间窗: Frequent sampling occasions during study period
次要结局
- Safety variables (adverse events, blood pressure, pulse, safety lab)(During the treatment period)
研究者
研究点 (1)
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