NCT01245790已完成1 期
An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg
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
- 24
- 试验地点
- 1
- 主要终点
- Plasma pharmacokinetic (PK) parameters
研究概览
简要总结
A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Stage 1 will include healthy subjects and subjects with end stage renal disease, while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in subjects with 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
- 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
- •Males or females (non child bearing potential) greater than or equal to 18 years of age with suitable veins for cannulation or repeated venipuncture and with a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive
- •Stable renal impairment with following creatinine clearance (CLCR): Stage 1 - End Stage Renal Disease (ESRD) < 15 mL/min (requiring dialysis); Stage 2 - Mild renal impairment ≥ 50 to < 80 mL/min; Moderate renal impairment ≥ 30 to <50 mL/min; and severe renal impairment 15 to < 30 mL/min
- •Healthy subjects with normal renal function must have good health based on medical history, physical examination , echocardiogram and clinical laboratory evaluations including creatinine clearance >80 ml/min"
- •Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen and hepatitis C antibody
排除标准
- •Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
- •Absolute neutrophil count less than 1600/mm3 or 1.6 x 109 L.
- •Healthy subjects only: Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration
- •Subjects with a history of multiple drug allergies or with a known allergy to the drug class of fostamatinib
- •In the opinion of the Investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding
研究组 & 干预措施
1
Experimental
Healthy subjects (Stage 1)
干预措施: fostamatinib (Drug)
2
Experimental
Mild renal impairment (Stage 2)
干预措施: fostamatinib (Drug)
3
Experimental
Moderate renal impairment (Stage 2)
干预措施: fostamatinib (Drug)
4
Experimental
Severe renal impairment (Stage 2)
干预措施: fostamatinib (Drug)
5
Experimental
End stage renal disease (Stage 1)
干预措施: fostamatinib (Drug)
结局指标
主要结局
Plasma pharmacokinetic (PK) parameters
Parameters include: AUC, Cmax
次要结局
- Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms
- Urine PK parameters of R406 and its N-glucuronide metabolite
- The effects of differences in protein binding by assessment of unbound R406 PK
研究者
研究点 (1)
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