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

AVEO Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Tivozanib hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01631097

AV-951-12-118

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)