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

NCT00887627 | Completed Phase 1

• 1 other identifier: 087-CL-094
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Pharmacokinetics; Protein Binding; Conivaptan; Vaprisol; Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Measure PK and protein binding of conivaptan

  5 days

Secondary Outcomes (1)

• Measure safety and tolerability of conivaptan

  5 days

Study Arms (3)

1. Mild Renal Function Impaired Subjects

EXPERIMENTAL

Drug: conivaptan hydrochloride

2. Moderate Renal Function Impaired Subjects

EXPERIMENTAL

Drug: conivaptan hydrochloride

3. Subjects with Normal Renal Function

EXPERIMENTAL

Drug: conivaptan hydrochloride

Interventions

conivaptan hydrochloride DRUG

intravenous

Also known as: Vaprisol, YM087

1. Mild Renal Function Impaired Subjects; 2. Moderate Renal Function Impaired Subjects; 3. Subjects with Normal Renal Function

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Hyponatremia

Interventions

conivaptan

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Art Wheeler, MD

  Cumberland Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 2, 2014

Record last verified: 2014-04

Locations

US (1)