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

Phase 1

Completed

• Conditions: Kidney Diseases; Hyponatremia
• Interventions: Drug: conivaptan hydrochloride

• Registration Number: NCT00887627
• Lead Sponsor: Cumberland Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-23
• Study First Posted: 2009-04-24
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Mild Renal Function Impaired Subjects	conivaptan hydrochloride	-
2. Moderate Renal Function Impaired Subjects	conivaptan hydrochloride	-
3. Subjects with Normal Renal Function	conivaptan hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Measure PK and protein binding of conivaptan	5 days

Secondary Outcome Measures

Name	Time	Method
Measure safety and tolerability of conivaptan	5 days