- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631097
A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function
January 23, 2014 updated by: AVEO Pharmaceuticals, Inc.
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States
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Orlando, Florida, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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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
|
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
|
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
|
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
|
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
|
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
|
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
|
pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: up to 16 weeks
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up to 16 weeks
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Change from baseline in vital signs
Time Frame: Baseline and End of Study Visit (Day 30)
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Baseline and End of Study Visit (Day 30)
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Change from baseline in physical examinations
Time Frame: Baseline and End of Study Visit (Day 30)
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Baseline and End of Study Visit (Day 30)
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Change from baseline in hematology including coagulation assessments
Time Frame: Baseline and End of Study Visit (Day 30)
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Baseline and End of Study Visit (Day 30)
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Change from baseline in chemistry assessments
Time Frame: Baseline and End of Study Visit (Day 30)
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Baseline and End of Study Visit (Day 30)
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Change from baseline in urinalysis assessments
Time Frame: Baseline and End of Study Visit (Day 30)
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Baseline and End of Study Visit (Day 30)
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Change from baseline in thyroid function tests
Time Frame: Baseline and End of Study Visit (Day 30)
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Baseline and End of Study Visit (Day 30)
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Change from baseline in electrocardiograms
Time Frame: Baseline and End of Study Visit (Day 30)
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Baseline and End of Study Visit (Day 30)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
June 1, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (Estimate)
June 28, 2012
Study Record Updates
Last Update Posted (Estimate)
January 27, 2014
Last Update Submitted That Met QC Criteria
January 23, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AV-951-12-118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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