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

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hyponatremia; Liver Disease

Treatments: Drug: conivaptan hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851227

087-CL-086

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

26 participants in 3 patient groups

1. Mildly Hepatic Impaired Subjects

Experimental group

Treatment:

Drug: conivaptan hydrochloride

2. Moderately Hepatic Impaired Subjects

Experimental group

Treatment:

Drug: conivaptan hydrochloride

3. Subjects with Normal Hepatic Function

Experimental group

Treatment:

Drug: conivaptan hydrochloride