Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
This is a phase 1, open-label study designed to determine the interaction of rifampin with linifanib.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Phase 1 Study To Assess the Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors|
- To investigate the effect of rifampin on the pharmacokinetic of linifanib in subjects with advanced or metastatic solid tumors. [ Time Frame: Blood samples for the PK of linifanib will be collected at various time points from Day 1 through Day 17. ] [ Designated as safety issue: No ]To assess the effect of rifampin on the pharmacokinetics of linifanib and metabolite(s), an analysis will be performed for the natural logarithms of Cmax and AUC of linifanib and metabolite(s) with concentrations that permit confident determination of values of the pharmacokinetic variables. A paired t-test will be performed to compare the central value on Study Day 13 (with rifampin) to that on Study Day 1 (without rifampin). Point estimates and 90% confidence intervals will also be provided.
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. [ Time Frame: Through out the study ] [ Designated as safety issue: Yes ]The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study.
- Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. [ Time Frame: Physical exam will be done at Screening, Day1, Day 13, Day 17/Final Visit and 30 day safety follow-up. Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits. ] [ Designated as safety issue: Yes ]Complete physical exam, including body weight, will be done at Screening and Day 1. A symptom-directed physical exam, including weight, will be done at Day 13, Day 17/Final Visit and 30 day safety follow-up.
- Safety: Clinical Lab Tests will be performed for each participant as a safety measure. [ Time Frame: Screening, Day 1, Day 13, Day 17/Final Visit and 30 day safety follow up visit. ] [ Designated as safety issue: Yes ]Chemistry, hematology, urinalysis lab tests.
|Study Start Date:||May 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
QD on Days 1 and 13
Other Name: ABT-869Drug: Rifampin
QD on Days 5-16
Other Name: Rifadin
This study is designed to explore the drug interaction between rifampin and linifanib to determine the potential effect of rifampin on the metabolism of linifanib. Linifanib will be taken alone or in combination with rifampin. The safety of a single dose administration of linifanib when administered alone and in combination with rifampin will be assessed. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401933
|United States, Arizona|
|Site Reference ID/Investigator# 49953|
|Tucson, Arizona, United States, 85724-5024|
|United States, Wisconsin|
|Site Reference ID/Investigator# 49952|
|Madison, Wisconsin, United States, 53792|
|Study Director:||Mark D. McKee, MD||Abbott|