A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
A Phase 1, Open-Label Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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California
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Anaheim、California、美国、92801
- Advanced Clinical Research Institute
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Colorado
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Lakewood、Colorado、美国、80228
- DaVita Clinical Research
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Florida
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Orlando、Florida、美国、32809
- Orlando Clinical Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Subjects with Normal Hepatic Function:
Female subject must be either:
- post-menopausal prior to Screening, or
- premenarchal prior to Screening, or
- documented surgically sterile or post hysterectomy, or
if of childbearing potential, must have a negative pregnancy test at Screening and must be using highly effective contraception prior to Screening and throughout the study period and for 28 days after final study drug administration
- Female subject must not be lactating and must not be breastfeeding at Screening or during the study period, and for 28 days after final study drug administration
- Female subject must not donate ova starting at Screening or during the study period, and for 28 days after final study drug administration
- Male subject must:
- be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 28 days after final study drug administration
not donate sperm starting at Screening and throughout the study period, and for at least 28 days after final study drug administration
- Subject weighs at least 45 kg and has a body mass index between 18 and 40 kg/m2 inclusive
- The subject must have clinical laboratory test results within normal range, including liver function tests (LFTs)
- The subject must have had a normal 12-lead electrocardiogram (ECG)
Hepatic Impaired Subjects:
Female subject must be either:
- post-menopausal prior to Screening, or
- premenarchal prior to Screening, or
- documented surgically sterile or post hysterectomy, or
- if of childbearing potential, must have a negative pregnancy test at Screening and must be using highly effective contraception prior to Screening and throughout the study period and for 28 days after final study drug administration
- Female subject must not be lactating and must not be breastfeeding at Screening or during the study period, and for 28 days after final study drug administration
- Female subject must not donate ova starting at Screening or during the study period, and for 28 days after final study drug administration
Male subject must:
- be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 28 days after final study drug administration
- not donate sperm starting at Screening and throughout the study period, and for at least 28 days after final study drug administration
- Subject meets criteria for severe hepatic impairment defined by Child-Pugh method
- Subject weighs at least 45 kg and has a body mass index between 18 and 40 kg/m2 inclusive
- The subject must have clinical laboratory test results within therapeutic range except for hepatic disease
- The subject must have had a normal 12-lead electrocardiogram (ECG)
Exclusion Criteria:
Subjects with Normal Hepatic Function:
- Subject has a history of a clinically significant illness, and associated clinical symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study
- Subject has evidence of biliary obstruction or other causes of hepatic impairment
- Subject is known to have hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is known to be HIV positive or has HIV antibodies
- Subject has an impaired ability to sense thirst
- Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L
- Subject has either a systolic blood pressure (BP) of greater than 140 mmHg or a diastolic BP of less than 56 mmHg
- Subject has taken any prescription or over-the-counter medications except for contraceptives, hormone replacement therapy and occasional acetaminophen, or alternative and complementary medicines within past 14 days
- Subject has a history of carcinoma, except for basal cell or cutaneous squamous cell carcinoma within past 5 years
- Subject drinks greater than 14 units of alcohol per week (Note: one unit = 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits)
- Subject has a history of substance abuse within past 6 months prior to Screening Visit or the subject tests positive at Screening or clinic admission for alcohol or drugs of abuse
- Subject is currently participating in another clinical trial or has received an investigational medication within past 30 days
- Subject is known to have hypersensitivity to conivaptan or its derivatives
- Subject has had a blood transfusion or donated/lost more than 550ml of blood within past 8 weeks
- Subject is incapable of being compliant with the protocol
Subjects with Hepatic Impairment:
- Subject has a history of a clinically significant illness, and associated clinical symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study. Subjects with controlled hypertension may be allowed
- Subject has a condition associated with hepatic disease including; biliary obstruction, or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver, fluctuating or rapidly deteriorating hepatic function, biliary liver cirrhosis, history or presence of hepatic encephalopathy greater than Grade 1 within past 3 months or unstable encephalopathy prior to Screening, tense ascites, esophageal/gastric variceal bleeding with past 6 months, server portal hypertension, surgical portal systemic shunt or peritoneal venous shunt, thrombocyte level below 50,000 x 10^9/L and prothrombin time (PT) above 18 seconds
- Subject is hypovolemic or has evidence of orthostatic hypotension
- Subject has an impaired ability to sense thirst
- Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L
- Subject has either a systolic blood pressure (BP) of greater than 140 mmHg or a diastolic BP of less than 56 mmHg
- Subject is known to be HIV positive or has HIV antibodies
- Subject has had a change in dose regimen of medication needed for their underlying medical condition with the past four weeks
- Subject is currently taking a prohibited medication
- Subject drinks greater than 14 units of alcohol per week (Note: one unit equals 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits)
- Subject has a history of substance abuse within past 6 months prior to Screening Visit or the subject tests positive at Screening or clinic admission for alcohol or drugs of abuse
- Subject is currently participating in another clinical trial or has received an investigational medication with past 30 days
- Subject has had a blood transfusion or donated/lost more than 550ml of blood within past 8 weeks
- Subject is known to have hypersensitivity of conivaptan or its derivatives
- Subject is incapable of being compliant with the protocol
学习计划
研究是如何设计的?
设计细节
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:肝功能正常的受试者
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Intravenous
其他名称:
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实验性的:Subjects with severe hepatic impairment
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Intravenous
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Assess the effect of severe hepatic impairment on the plasma drug concentration of conivaptan through analysis of blood samples
大体时间:5 days
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5 days
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合作者和调查者
调查人员
- 研究主任:Art Wheeler, MD、Cumberland Pharmaceuticals, Inc.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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