Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function

Study Overview
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Brief Summary
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A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function

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

Conditions
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Liver Disease, Hyponatremia

Intervention / Treatment
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* Drug: conivaptan hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Normal Hepatic Function: Weighs at least 45 kg Body mass index between 18 and 40 kg/m2 inclusive Must have normal hepatic function Hepatic Impaired Subjects: Weighs at least 45 kg Meets criteria for mild or moderate hepatic impairment defined by Child-Pugh method Body mass index between 18 and 40 kg/m2 inclusive Exclusion Criteria: Subjects with Normal Hepatic Function: Smokes more than 10 cigarettes per day Known to be HIV positive or has HIV antibodies Has clinically significant history or presence of illness, malignancy, or immunodeficiency Is Hepatitis A, B, or C positive Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration History of substance abuse within 6 months prior to screening Hepatic Impaired Subjects: Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced acidities, portal hypertension, or biliary liver cirrhosis Is hypovolemic or has evidence of orthostatic hypotension Smokes more than 10 cigarettes per day Known to be HIV positive or has HIV antibodies Has clinically significant history or presence of illness, malignancy, or immunodeficiency Has clinically significant history or presence of GI symptoms other than those associated with moderate hepatic impairment Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration History of substance abuse within 6 months prior to screening

Ages Eligible for Study
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Minimum Age: 30 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. Mildly Hepatic Impaired Subjects<br> | Drug: conivaptan hydrochloride<br>* intravenous<br>* Other names: YM087;|
| Experimental: 2. Moderately Hepatic Impaired Subjects<br> | Drug: conivaptan hydrochloride<br>* intravenous<br>* Other names: YM087;|
| Experimental: 3. Subjects with Normal Hepatic 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 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, Liver Disease