A Phase 1, Open Label, Randomized, Adaptive, Cross-Over Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors
This study is designed to evaluate the bioavailability of linifanib from two formulations
and the effect of food on the pharmacokinetics of the linifanib formulation intended for
commercialization. Subjects may enroll in a separate extension study to continue receiving
linifanib after completion of this study.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Calculate the Cmax and Tmax of participating subjects
PK parameters will be measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose in each study period.
United States: Food and Drug Administration
|Site Reference ID/Investigator# 51465||Baltimore, Maryland 21231|
|Site Reference ID/Investigator# 61282||Detroit, Michigan 48201|
|Site Reference ID/Investigator# 51463||Lebanon, New Hampshire 03756-0001|
|Site Reference ID/Investigator# 52122||San Antonio, Texas 78229|