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

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851227
• Other study ID #: 087-CL-086
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2009
• Last updated: April 30, 2014
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: April 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyponatremia
• Liver Disease
• Liver Diseases

Intervention

Drug:
• conivaptan hydrochloride
intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure PK and protein binding of conivaptan		5 days	No
Secondary	Measure tolerability of conivaptan		5 days	No

External Links

•   Link to Results on JAPIC