Status:
COMPLETED
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
Lead Sponsor:
Cumberland Pharmaceuticals
Conditions:
Liver Disease
Hyponatremia
Eligibility:
All Genders
30-70 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00851227
Start Date
February 1 2009
End Date
January 1 2010
Last Update
May 2 2014
Active Locations (1)
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1
Miami, Florida, United States, 33014