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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851227

Enrollment

Registered

2009-02-25

Start date

2009-02-28

Completion date

2010-01-31

Last updated

2014-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia, Liver Disease

Keywords

Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Liver Disease

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

Interventions

DRUGconivaptan hydrochloride

intravenous

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Measure PK and protein binding of conivaptan	5 days

Secondary

Measure	Time frame
Measure tolerability of conivaptan	5 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026