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

NCT ID: NCT00887627

Last Updated: 2014-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Kidney Diseases; Hyponatremia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

1. Mild Renal Function Impaired Subjects

Group Type: EXPERIMENTAL

conivaptan hydrochloride

Intervention Type: DRUG

intravenous

2. Moderate Renal Function Impaired Subjects

Group Type: EXPERIMENTAL

conivaptan hydrochloride

Intervention Type: DRUG

intravenous

3. Subjects with Normal Renal Function

Group Type: EXPERIMENTAL

conivaptan hydrochloride

Intervention Type: DRUG

intravenous

Interventions

conivaptan hydrochloride

intravenous

Intervention Type: DRUG

Other Intervention Names

Vaprisol; YM087

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Art Wheeler, MD

Role: STUDY_DIRECTOR

Cumberland Pharmaceuticals, Inc.

Locations

Anaheim, California, United States

Countries

United States

Other Identifiers

087-CL-094

Identifier Type: -

Identifier Source: org_study_id