DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Cumberland Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Disease; Hyponatremia

Intervention: conivaptan hydrochloride (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Cumberland Pharmaceuticals

Official(s) and/or principal investigator(s):
Art Wheeler, MD, Study Director, Affiliation: Cumberland Pharmaceuticals Inc.

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

Clinical Details

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

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

Primary outcome: Measure PK and protein binding of conivaptan

Secondary outcome: Measure tolerability of conivaptan

Eligibility

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Miami, Florida 33014, United States
Additional Information

Link to Results on JAPIC

Starting date: February 2009
Last updated: April 30, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017