A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function
Phase 1
Completed
- Conditions
- Hepatic Impairment
- Registration Number
- NCT01631097
- Lead Sponsor
- AVEO Pharmaceuticals, Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Apparent terminal elimination half-life (t1/2) pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose Apparent total clearance (CL/F) 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) pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose Maximum Observed Concentration (Cmax) pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose Time to maximum concentration (Tmax) 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) 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-∞) 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) pre-dose, 1, 3, 5, 7, 10, 12, 18, 24, 36, 48, 96, 168, 336, and 504 hours postdose
- Secondary Outcome Measures
Name Time Method Change from baseline in physical examinations Baseline and End of Study Visit (Day 30) Change from baseline in thyroid function tests Baseline and End of Study Visit (Day 30) Change from baseline in electrocardiograms Baseline and End of Study Visit (Day 30) Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 16 weeks Change from baseline in vital signs Baseline and End of Study Visit (Day 30) Change from baseline in chemistry assessments Baseline and End of Study Visit (Day 30) Change from baseline in urinalysis assessments Baseline and End of Study Visit (Day 30) Change from baseline in hematology including coagulation assessments Baseline and End of Study Visit (Day 30)