A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

This Phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics, safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of hepatic impairment and normal hepatic function.

Key facts

Study ID

NCT01631097

Run by

AVEO Pharmaceuticals, Inc.

People needed

44

Starts

2012-05-01

Expected to finish

2014-01-01

Last updated by the study team

2014-01-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• BMI between 18 to 38 kg/m2
• diagnosis of chronic or stable hepatic insufficiency, with a Child-Pugh classification scores of mild, moderate or severe.

You may not qualify if…

• Current or previous history of hepatic carcinoma, hepatorenal syndrome, portacaval shunt surgery, significant hepatic encephalopathy, severe ascites, or pleural effusion
• Currently undergoing dialysis
• Poor peripheral venous access
• Pregnancy or lactation

Where it is running

• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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