NCT01631097

A Single-Dose Study of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function

A Phase 1, Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Tivozanib in Subjects With Hepatic Impairment and Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Tivozanib hydrochloride	Single oral capsule 1.5 mg tivozanib hydrochloride

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-06-28
• Last updated: 2014-01-27

Locations

2 sites across 1 country: United States