Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Weighs at least 45 kg
Body mass index between 18 and 40 kg/m2 inclusive
Must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects
Must have a screening and pre-dose estimated glomerular filtration rate (GFR) that corresponds with the level of renal impairment based on the abbreviated Modification of Diet in Renal Disease (MDRD) formula
Female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal
Subject is known to be HIV positive or has HIV antibodies
Has clinically significant history or presence of illness, medical condition, or laboratory abnormality
Is Hepatitis positive
Subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study
History of substance abuse within 6 months prior to screening
Has clinically significant history or presence of psychiatric illness, malignancy, or immunodeficiency syndrome
Has abnormal liver function tests (ALT, AST, and/or bilirubin)
Has had a blood transfusion or donated/lost more than 450ml of blood within 56 days of study drug administration or has donated plasma within 7 days prior to study drug administration