A Phase 1 Study To Assess the Effect of Rifampin on the Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
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.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
To investigate the effect of rifampin on the pharmacokinetic of linifanib in subjects with advanced or metastatic solid tumors.
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.
Blood samples for the PK of linifanib will be collected at various time points from Day 1 through Day 17.
Mark D. McKee, MD
United States: Food and Drug Administration
|Site Reference ID/Investigator# 49953||Tucson, Arizona 85724-5024|
|Site Reference ID/Investigator# 49952||Madison, Wisconsin 53792|