A Phase Ib, Multi-center, Two Parallel Group, Open-label, Drug-drug Interaction Study to Assess the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients With Advanced Solid Tumors
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pharmacokinetics (PK) parameter AUClast for S- and R-warfarin
Pharmacokinetics of warfarin : Maximum observed plasma concentration after drug administration
7 days
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CLDE225A2112
NCT01769768
April 2013
September 2014
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Cancer Therapy & Research Center | San Antonio, Texas 78229 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Utah / Huntsman Cancer Institute | Salt Lake City, Utah 84103 |
Massachusetts General Hospital Dana-Farber Cancer Institute | Boston, Massachusetts 02114 |
University of Pennsylvania--Abramson Cancer Center Abramson Cancer Center | Philadelphia, Pennsylvania 19104 |
Medical University of South Carolina Dept.of Neurosciences/MS Ctr. | Charleston, South Carolina 29425 |