NCT00472836已完成1 期
A Phase 1, Open-Label, Parallel Group, Multiple-Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of CP-945,598 Administered To Subjects With Severely Impaired And Normal Renal Function
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
- Pfizer
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21,
研究概览
简要总结
CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy control 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal Subjects: 1.Healthy. 2.Matched for age (± 5 yrs), weight (± 10 kg), and gender ratio (± 2 subjects per gender).
- •Subjects with Renal Disease:
- •Severe impairment (Creatinine clearance <30 mL/min)
- •Stable renal disease:no change in the last 30 days.
- •Stable dose of medication and/or treatment.
- •Reasonably well-controlled type 1 and type 2 diabetics
排除标准
- •All subjects: Non-prescribed use of drugs of abuse/ recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure parameters falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits
- •Normal subjects: Medically important health conditions; recent use of prescription or non-prescription medications.
- •Subjects with renal disease: Subjects requiring dialysis; certain chronic medical conditions; patients who have received renal transplant; severe and/or poorly controlled diabetes; Treatment with protocol-specified drugs that may alter the way the body absorbs or processes CP-945,598.
研究组 & 干预措施
Normal renal function
Experimental
干预措施: CP-945,598 (Drug)
Severe renal impairment
Experimental
干预措施: CP-945,598 (Drug)
结局指标
主要结局
Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21,
时间窗: 14 days
28, 35
时间窗: 14 days
次要结局
- Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14(14 days)
- ECGs on Days 1,7 and 14(14 days)
- Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35(14 days)
- Adverse event monitoring throughout duration of the study(14 days)
研究者
研究点 (1)
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