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

Cumberland Pharmaceuticals3 sites in 1 country17 target enrollmentApril 2011

ConditionsLiver Disease

Interventionsconivaptan hydrochloride

Drugsconivaptan hydrochloride

Overview

Phase: Phase 1
Intervention: conivaptan hydrochloride
Conditions: Liver Disease
Sponsor: Cumberland Pharmaceuticals
Enrollment: 17
Locations: 3
Primary Endpoint: Assess the effect of severe hepatic impairment on the plasma drug concentration of conivaptan through analysis of blood samples
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.

Detailed Description

Subjects will be admitted to the Phase 1 unit Day -2 and will remain confined to the unit until discharge on Study Day 5 after completion of all study procedures.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

February 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cumberland Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects with Normal Hepatic Function:
•Female subject must be either:
•post-menopausal prior to Screening, or
•premenarchal prior to Screening, or
•documented surgically sterile or post hysterectomy, or
•if of childbearing potential, must have a negative pregnancy test at Screening and must be using highly effective contraception prior to Screening and throughout the study period and for 28 days after final study drug administration
•Female subject must not be lactating and must not be breastfeeding at Screening or during the study period, and for 28 days after final study drug administration
•Female subject must not donate ova starting at Screening or during the study period, and for 28 days after final study drug administration
•Male subject must:
•be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 28 days after final study drug administration

Exclusion Criteria

•Subjects with Normal Hepatic Function:
•Subject has a history of a clinically significant illness, and associated clinical symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study
•Subject has evidence of biliary obstruction or other causes of hepatic impairment
•Subject is known to have hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is known to be HIV positive or has HIV antibodies
•Subject has an impaired ability to sense thirst
•Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L
•Subject has either a systolic blood pressure (BP) of greater than 140 mmHg or a diastolic BP of less than 56 mmHg
•Subject has taken any prescription or over-the-counter medications except for contraceptives, hormone replacement therapy and occasional acetaminophen, or alternative and complementary medicines within past 14 days
•Subject has a history of carcinoma, except for basal cell or cutaneous squamous cell carcinoma within past 5 years
•Subject drinks greater than 14 units of alcohol per week (Note: one unit = 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits)