Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK) profile of tivozanib.
This Phase 1, open-label, two-period, single-sequence study is designed to evaluate the effect of steady-state rifampin on the PK profile, safety, and tolerability of a single 1.5-mg tivozanib dose. On Day 1 of the first period, subjects will receive a single 1.5 mg dose of tivozanib, and remain at the unit for at least 48 hours postdose followed by outpatient visits for PK sampling and safety assessments up to 3 weeks postdose. For Period 2, subjects will be administered 600 mg of rifampin once daily (QD).for 6 days. On the 4th day of Period 2, 1.5mg of tivozanib will be administered with 600mg of rifampin. PK sampling will continue for 3-weeks postdose while the subjects continue to receive 600mg of rifampin daily. An end of study visit will be completed 1-week after the last dose of rifampin.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tivozanib | Experimental | Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tivozanib | Drug | Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity. |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the effect of steady-state rifampin on the pharmacokinetics (PK) of a single 1.5 mg tivozanib dose in healthy subjects. | Blood samples for PK analysis of serum tivozanib levels will be collected for a 3-week period following each dose. | Planned Enrollment/Screening Duration: Approximately 4 weeks. |
| To assess the safety and tolerability of tivozanib administered alone and in the presence of steady-state rifampin in healthy subjects. | Safety assessments will be completed by evaluation of physical exam, ECGs, laboratory assessments and adverse events | Planned Enrollment/Screening Duration: Approximately 4 weeks. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Daytona Beach | Florida | 32117 | United States |
Not provided
| ID | Term |
|---|---|
| C553176 | tivozanib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|