A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)
- Registration Number
- NCT01114191
- Lead Sponsor
- Abbott
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 ABT-869 - Arm 1 ketoconazole -
- Primary Outcome Measures
Name Time Method To investigate the effect of ketoconazole on the pharmacokinetics of ABT-869 in subjects with advanced or metastatic solid tumors. Different timepoints on Days 1-12 Blood samples for the PK of ABT-869 and ketoconazole will be collected at designated time points throughout the study.
- Secondary Outcome Measures
Name Time Method Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. Throughout the study Adverse event monitoring, lab tests assessments, physical exam and vital signs will be evaluated throughout the study.
Trial Locations
- Locations (2)
Site Reference ID/Investigator# 35784
🇺🇸Detroit, Michigan, United States
Site Reference ID/Investigator# 36527
🇺🇸Lebanon, New Hampshire, United States