An Open-Label, Phase 1, Randomized, Two-Treatment, Two-Period, Two-Way Crossover, Relative Bioavailability Study Of A Capsule And A Tablet Formulation Of ARQ 197 In Subjects With Advanced Solid Tumors
Interventional
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of the relative bioavailability of ARQ 197 tablet formulation with capsule C formulation
The primary endpoints are the area under the concentration time curve from time of dosing until 12 hours post-dose (AUC0-12) and maximum observed concentration in plasma (Cmax) of ARQ 197 following the administration of the tablet (fed conditions) and capsule formulation (at least 1 hour before or 2 hours after a meal).
14 days
No
United States: Food and Drug Administration
ARQ 197-A-U157
NCT01149720
July 2010
March 2011
Name | Location |
---|---|
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Premiere Oncology | Santa Monica, California 90404 |
Sarah Cannon Research Institute (SCRI) | Nashville, Tennessee 37203 |
START - South Texas Accelerated Research Therapeutics, LLC | San Antonio, Texas 78229 |