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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan

Conditions
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Kidney Diseases, Hyponatremia

Intervention / Treatment
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* Drug: conivaptan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Mild Renal Function Impaired Subjects<br> | Drug: conivaptan hydrochloride<br>* intravenous<br>* Other names: YM087;|
| Experimental: 2. Moderate Renal Function Impaired Subjects<br> | Drug: conivaptan hydrochloride<br>* intravenous<br>* Other names: YM087;|
| Experimental: 3. Subjects with Normal Renal Function<br> | Drug: conivaptan hydrochloride<br>* intravenous<br>* Other names: YM087;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure PK and protein binding of conivaptan |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure safety and tolerability of conivaptan |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Kidney Diseases