Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
Overview
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.
Full Title of Study: “A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2010
Interventions
- Drug: conivaptan hydrochloride
- intravenous
Arms, Groups and Cohorts
- Experimental: 1. Mild Renal Function Impaired Subjects
- Experimental: 2. Moderate Renal Function Impaired Subjects
- Experimental: 3. Subjects with Normal Renal Function
Clinical Trial Outcome Measures
Primary Measures
- Measure PK and protein binding of conivaptan
- Time Frame: 5 days
Secondary Measures
- Measure safety and tolerability of conivaptan
- Time Frame: 5 days
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Cumberland Pharmaceuticals
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Art Wheeler, MD, Study Director, Cumberland Pharmaceuticals, Inc.
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