A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)
This is a phase 1, open-label study designed to determine the interaction of ketoconazole with ABT-869.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Ph I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)|
- To investigate the effect of ketoconazole on the pharmacokinetics of ABT-869 in subjects with advanced or metastatic solid tumors. [ Time Frame: Different timepoints on Days 1-12 ] [ Designated as safety issue: No ]Blood samples for the PK of ABT-869 and ketoconazole will be collected at designated time points throughout the study.
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]Adverse event monitoring, lab tests assessments, physical exam and vital signs will be evaluated throughout the study.
|Study Start Date:||May 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
2.5mg [5 mg days 1, 8 and 12. 17.5 mg on days 13 and after]
Other Name: linifanib, ABT-869Drug: ketoconazole
400 mg days 6-11
Other Name: ketoconazole
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.
|United States, Michigan|
|Site Reference ID/Investigator# 35784|
|Detroit, Michigan, United States, 48201|
|United States, New Hampshire|
|Site Reference ID/Investigator# 36527|
|Lebanon, New Hampshire, United States, 03756-0001|
|Study Director:||Mark D McKee, MD||Abbott|