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

AVEO Pharmaceuticals, Inc.44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hepatic Impairment

Interventions

Tivozanib hydrochlorideDRUG

Single oral capsule 1.5 mg tivozanib hydrochloride

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Miami, Florida, United States

Unnamed facility

Orlando, Florida, United States