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
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
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