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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

Details

• Lead Sponsor: Cumberland Pharmaceuticals
• Treatments: Conivaptan

Criteria

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 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