NCT00887627已完成1 期
A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan
Cumberland Pharmaceuticals0 个研究点目标入组 25 人开始时间: 2009年4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
- 25
- 主要终点
- Measure PK and protein binding of conivaptan
研究概览
简要总结
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weighs at least 45 kg
- •Body mass index between 18 and 40 kg/m2 inclusive
- •Must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects
- •Must have a screening and pre-dose estimated glomerular filtration rate (GFR) that corresponds with the level of renal impairment based on the abbreviated Modification of Diet in Renal Disease (MDRD) formula
- •Female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal
排除标准
- •Subject is known to be HIV positive or has HIV antibodies
- •Has clinically significant history or presence of illness, medical condition, or laboratory abnormality
- •Is Hepatitis positive
- •Subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study
- •History of substance abuse within 6 months prior to screening
- •Has clinically significant history or presence of psychiatric illness, malignancy, or immunodeficiency syndrome
- •Has abnormal liver function tests (ALT, AST, and/or bilirubin)
- •Has had a blood transfusion or donated/lost more than 450ml of blood within 56 days of study drug administration or has donated plasma within 7 days prior to study drug administration
研究组 & 干预措施
1. Mild Renal Function Impaired Subjects
Experimental
干预措施: conivaptan hydrochloride (Drug)
2. Moderate Renal Function Impaired Subjects
Experimental
干预措施: conivaptan hydrochloride (Drug)
3. Subjects with Normal Renal 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 safety and tolerability of conivaptan(5 days)
研究者
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