Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
- Registration Number
- NCT00851227
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
-
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
Exclusion Criteria
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. Mildly Hepatic Impaired Subjects conivaptan hydrochloride - 2. Moderately Hepatic Impaired Subjects conivaptan hydrochloride - 3. Subjects with Normal Hepatic Function conivaptan hydrochloride -
- Primary Outcome Measures
Name Time Method Measure PK and protein binding of conivaptan 5 days
- Secondary Outcome Measures
Name Time Method Measure tolerability of conivaptan 5 days