NCT01363778

A Phase 1 Study to Evaluate The Effect of Ketoconazole on the Pharmacokinetics of Tivozanib in Healthy Subjects

A Phase 1, Open-label Study to Evaluate The Effect of Ketoconazole on the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Tivozanib 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 is designed to evaluate the effect ketoconazole on the Pharmacokinetic profile of tivozanib.

Detailed description

This Phase 1, open-label, two-period, single-sequence study is designed to evaluate the effect of steady-state ketoconazole 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 400 mg of ketoconazole once daily (QD) for 3 days. On the 4th day of Period 2, 1.5mg of tivozanib will be administered with 400mg of ketoconazole. PK sampling will continue for 3-weeks postdose while the subjects continue to receive 400mg of ketoconazole daily. An end of study visit will be completed 1-week after the last dose of ketoconazole.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	tivozanib	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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-06-02
• Last updated: 2012-06-05

Locations

1 site across 1 country: United States