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

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Kidney Diseases; Hyponatremia

Treatments: Drug: conivaptan hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887627

087-CL-094

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

25 participants in 3 patient groups

1. Mild Renal Function Impaired Subjects

Experimental group

Treatment:

Drug: conivaptan hydrochloride

2. Moderate Renal Function Impaired Subjects

Experimental group

Treatment:

Drug: conivaptan hydrochloride

3. Subjects with Normal Renal Function

Experimental group

Treatment:

Drug: conivaptan hydrochloride