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

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tivozanib hydrochloride

About this trial

This is an interventional basic science trial for Hepatic Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Outcomes

Primary Outcome Measures

Maximum Observed Concentration (Cmax)

Time to maximum concentration (Tmax)

Area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0 t)

Area under the concentration-time curve extrapolated to infinity (AUC0-∞)

Apparent terminal elimination rate constant (λz)

Apparent terminal elimination half-life (t1/2)

Apparent total clearance (CL/F)

Apparent volume of distribution (Vz/F)

Secondary Outcome Measures

Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Change from baseline in vital signs

Change from baseline in physical examinations

Change from baseline in hematology including coagulation assessments

Change from baseline in chemistry assessments

Change from baseline in urinalysis assessments

Change from baseline in thyroid function tests

Change from baseline in electrocardiograms

Full Information

NCT ID

NCT01631097

First Posted

June 1, 2012

Last Updated

January 23, 2014

Sponsor

AVEO Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01631097

Brief Title

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

Official Title

A Phase 1, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AVEO Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tivozanib hydrochloride

Intervention Description

Single oral capsule 1.5 mg tivozanib hydrochloride

Primary Outcome Measure Information:

Title

Maximum Observed Concentration (Cmax)

Time Frame