Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function

Trial end date:
Target enrollment:
Participant gender:
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Lead Sponsor:
Cumberland Pharmaceuticals
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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