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

NCT00851227 | Completed Phase 1

• 1 other identifier: 087-CL-086
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Pharmacokinetics; Protein Binding; Conivaptan; Vaprisol; Liver Disease

Outcome Measures

Primary Outcomes (1)

• Measure PK and protein binding of conivaptan

  5 days

Secondary Outcomes (1)

• Measure tolerability of conivaptan

  5 days

Study Arms (3)

1. Mildly Hepatic Impaired Subjects

EXPERIMENTAL

Drug: conivaptan hydrochloride

2. Moderately Hepatic Impaired Subjects

EXPERIMENTAL

Drug: conivaptan hydrochloride

3. Subjects with Normal Hepatic Function

EXPERIMENTAL

Drug: conivaptan hydrochloride

Interventions

conivaptan hydrochloride DRUG

intravenous

Also known as: Vaprisol, YM087

1. Mildly Hepatic Impaired Subjects; 2. Moderately Hepatic Impaired Subjects; 3. Subjects with Normal Hepatic Function

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Miami, Florida, 33014, United States

Location

MeSH Terms

Conditions

Liver Diseases; Hyponatremia

Interventions

conivaptan

Condition Hierarchy (Ancestors)

Digestive System 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: February 23, 2009
• First Posted: February 25, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 2, 2014

Record last verified: 2014-04

Locations

US (1)