NCT00851227已完成1 期
A Phase 1, Open-Label Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
Cumberland Pharmaceuticals0 个研究点目标入组 26 人开始时间: 2009年2月最近更新:
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
- 入组人数
- 26
- 主要终点
- Measure PK and protein binding of conivaptan
研究概览
简要总结
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with Normal Hepatic Function:
- •Weighs at least 45 kg
- •Body mass index between 18 and 40 kg/m2 inclusive
- •Must have normal hepatic function
- •Hepatic Impaired Subjects:
- •Weighs at least 45 kg
- •Meets criteria for mild or moderate hepatic impairment defined by Child-Pugh method
- •Body mass index between 18 and 40 kg/m2 inclusive
排除标准
- •Subjects with Normal Hepatic Function:
- •Smokes more than 10 cigarettes per day
- •Known to be HIV positive or has HIV antibodies
- •Has clinically significant history or presence of illness, malignancy, or immunodeficiency
- •Is Hepatitis A, B, or C positive
- •Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
- •History of substance abuse within 6 months prior to screening
- •Hepatic Impaired Subjects:
- •Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced acidities, portal hypertension, or biliary liver cirrhosis
- •Is hypovolemic or has evidence of orthostatic hypotension
- •Smokes more than 10 cigarettes per day
- •Known to be HIV positive or has HIV antibodies
- •Has clinically significant history or presence of illness, malignancy, or immunodeficiency
- •Has clinically significant history or presence of GI symptoms other than those associated with moderate hepatic impairment
- •Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
- •History of substance abuse within 6 months prior to screening
研究组 & 干预措施
1. Mildly Hepatic Impaired Subjects
Experimental
干预措施: conivaptan hydrochloride (Drug)
2. Moderately Hepatic Impaired Subjects
Experimental
干预措施: conivaptan hydrochloride (Drug)
3. Subjects with Normal Hepatic Function
Experimental
干预措施: conivaptan hydrochloride (Drug)
结局指标
主要结局
Measure PK and protein binding of conivaptan
时间窗: 5 days
次要结局
- Measure tolerability of conivaptan(5 days)
研究者
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