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

Completed · Phase 1

Conditions studied: Liver Disease, Hyponatremia

In brief

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

Key facts

Study ID

NCT00851227

Run by

Cumberland Pharmaceuticals

People needed

26

Starts

2009-02-01

Expected to finish

2010-01-01

Last updated by the study team

2014-05-02

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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