Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: Tivozanib hydrochloride Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : May 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Tivozanib hydrochloride
    Single oral capsule 1.5 mg tivozanib hydrochloride

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]

Secondary Outcome Measures :
  1. Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: up to 16 weeks ]
  2. Change from baseline in vital signs [ Time Frame: Baseline and End of Study Visit (Day 30) ]
  3. Change from baseline in physical examinations [ Time Frame: Baseline and End of Study Visit (Day 30) ]
  4. Change from baseline in hematology including coagulation assessments [ Time Frame: Baseline and End of Study Visit (Day 30) ]
  5. Change from baseline in chemistry assessments [ Time Frame: Baseline and End of Study Visit (Day 30) ]
  6. Change from baseline in urinalysis assessments [ Time Frame: Baseline and End of Study Visit (Day 30) ]
  7. Change from baseline in thyroid function tests [ Time Frame: Baseline and End of Study Visit (Day 30) ]
  8. Change from baseline in electrocardiograms [ Time Frame: Baseline and End of Study Visit (Day 30) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631097


Locations
Layout table for location information
United States, Florida
Miami, Florida, United States
Orlando, Florida, United States
Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01631097    
Other Study ID Numbers: AV-951-12-118
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases