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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
 (submitted: June 27, 2012)
  • 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
 (submitted: June 27, 2012)
  • 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
 (submitted: June 27, 2012)
44
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 No
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