Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Treatments: Conivaptan

Criteria

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