NCT00645021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 Impaired And Normal Hepatic 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
- 24
- 试验地点
- 1
- 主要终点
- Measurement of drug and metabolite concentrations in serum collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35
研究概览
简要总结
CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its 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 mild and moderate hepatic 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender)
- •Subjects with hepatic disease:
- •mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9).
- •stable hepatic disease: no changes in the last 30 days.
- •stable dose of medication and/or treatment.
排除标准
- •All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ECG and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits
- •Normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits
- •Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive blood alcohol test/alcohol breathalyzer at screening or on Day 0.
研究组 & 干预措施
Mild hepatic function
Experimental
干预措施: CP-945,598 (Drug)
Moderate hepatic function
Experimental
干预措施: CP-945,598 (Drug)
Normal hepatic function
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 collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35
时间窗: 14 days
次要结局
- ECGs on Days 1, 7, and 14(14 days)
- Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14(14 days)
- Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35(14 days)
- Adverse event monitoring throughout duration of the study(14 days)
研究者
研究点 (1)
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