NCT01114191

A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)

Ph I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, open-label study designed to determine the interaction of ketoconazole with ABT-869.

Detailed description

This study is designed to explore the drug interaction between ketoconazole and ABT-869 to determine the potential effect of ketoconazole on the metabolism of ABT-869. ABT-869 will be taken alone or in combination with ketoconazole. The safety of a single dose administration of ABT-869 when administered alone and in combination with ketoconazole will be assessed.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	ABT-869	2.5mg \[5 mg days 1, 8 and 12. 17.5 mg on days 13 and after\]
DRUG	ketoconazole	400 mg days 6-11

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-05-03
• Last updated: 2011-07-26

Locations

2 sites across 1 country: United States