NCT01316848

A Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Tivozanib (AV-951) in Healthy Subjects

A Phase 1, Single Center, Open-label, Randomized, Two-period Crossover Food Effect Study of Single Doses of Tivozanib (AV-951) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of 1.5 mg tivozanib in normal healthy subjects.

Detailed description

This study will be an open-label, randomized, two-period, crossover PK food effect study of tivozanib administered orally at 1.5 mg. Subjects will be screened for eligibility up to 28 days prior to entry into the study. For each of 2 study periods, subjects will be admitted to the clinical research unit (CRU) on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for each of the 2 study periods, subjects will receive a single oral dose of 1.5 mg tivozanib in either the fasted or fed state. Subjects will remain at the CRU for at least 48 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring. Subjects will return to the CRU on an outpatient basis for collection of additional blood samples for up to 504 hours postdose.

Conditions

• Food Effect of Tivozanib in Health Subjects

Interventions

Type	Name	Description
DRUG	tivozanib	tivozanib 1.5 mg capsule, 2 discrete single doses separated by 6-weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-03-16
• Last updated: 2012-06-05

Locations

1 site across 1 country: United States