Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-29 @ 7:12 PM
Study NCT ID:
NCT01363804
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Tivozanib in Healthy Subjects
Sponsor:
AVEO Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Two-period, Single-sequence Study to Evaluate the Effect of Rifampin on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Tivozanib in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to evaluate the effect of rifampin on the Pharmacokinetic (PK) profile of tivozanib.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: