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

NCT ID: NCT00851227

Last Updated: 2014-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-01-31

Brief Summary

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

Conditions

Liver Disease; Hyponatremia

Study Design

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

Study Groups

1. Mildly Hepatic Impaired Subjects

Group Type: EXPERIMENTAL

conivaptan hydrochloride

Intervention Type: DRUG

intravenous

2. Moderately Hepatic Impaired Subjects

Group Type: EXPERIMENTAL

conivaptan hydrochloride

Intervention Type: DRUG

intravenous

3. Subjects with Normal Hepatic 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

• 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

• Minimum Eligible Age: 30 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

Miami, Florida, United States

Countries

United States

Other Identifiers

087-CL-086

Identifier Type: -

Identifier Source: org_study_id