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

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ClinicalTrials.gov Identifier: NCT01631097

Recruitment Status : Completed

First Posted : June 28, 2012

Last Update Posted : January 27, 2014

Sponsor:

Information provided by (Responsible Party):

AVEO Pharmaceuticals, Inc.

Tracking Information

First Submitted Date ^ICMJE

June 1, 2012

First Posted Date ^ICMJE

June 28, 2012

Last Update Posted Date

January 27, 2014

Study Start Date ^ICMJE

May 2012

Actual Primary Completion Date

January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Observed Concentration (Cmax) [ Time Frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose ]
Time to maximum concentration (Tmax) [ Time Frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose ]
Area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0 t) [ Time Frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose ]
Area under the concentration-time curve extrapolated to infinity (AUC0-∞) [ Time Frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose ]
Apparent terminal elimination rate constant (λz) [ Time Frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose ]
Apparent terminal elimination half-life (t1/2) [ Time Frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose ]
Apparent total clearance (CL/F) [ Time Frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose ]
Apparent volume of distribution (Vz/F) [ Time Frame: pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 16 weeks ]
Change from baseline in vital signs [ Time Frame: Baseline and End of Study Visit (Day 30) ]
Change from baseline in physical examinations [ Time Frame: Baseline and End of Study Visit (Day 30) ]
Change from baseline in hematology including coagulation assessments [ Time Frame: Baseline and End of Study Visit (Day 30) ]
Change from baseline in chemistry assessments [ Time Frame: Baseline and End of Study Visit (Day 30) ]
Change from baseline in urinalysis assessments [ Time Frame: Baseline and End of Study Visit (Day 30) ]
Change from baseline in thyroid function tests [ Time Frame: Baseline and End of Study Visit (Day 30) ]
Change from baseline in electrocardiograms [ Time Frame: Baseline and End of Study Visit (Day 30) ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Condition ^ICMJE

Hepatic Impairment

Intervention ^ICMJE

Drug: Tivozanib hydrochloride

Single oral capsule 1.5 mg tivozanib hydrochloride

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

January 2014

Actual Primary Completion Date

January 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01631097

Other Study ID Numbers ^ICMJE

AV-951-12-118

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

AVEO Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

AVEO Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

AVEO Pharmaceuticals, Inc.

Verification Date

January 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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