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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tivozanib hydrochloride | Drug | Single oral capsule 1.5 mg tivozanib hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States | ||||
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| Change from baseline in physical examinations |
| Baseline and End of Study Visit (Day 30) |
| Change from baseline in hematology including coagulation assessments | 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 thyroid function tests | Baseline and End of Study Visit (Day 30) |
| Change from baseline in electrocardiograms | Baseline and End of Study Visit (Day 30) |
| Orlando |
| Florida |
| United States |