An Open-label, Single-dose, Randomized, Crossover Study to Determine the Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsule in Solid Tumor Cancer Subjects
This study is being conducted to determine whether the pharmacokinetics of a single dose of
tesetaxel administered as a capsule is affected by co-administration with food (a high-fat
meal).
Interventional
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Pharmacokinetic parameters
Pharmacokinetic parameters include the area under the blood concentration-time curve (AUC0-inf, AUC0-t), concentration 24 h post dose (C24), maximum blood concentration (Cmax), time to maximum blood concentration (Tmax), terminal half-life (t½), and oral clearance (CL/F)
Predose and postdosing up to 36 days after administration of each dose
No
Harry W Alcorn, PharmD
Principal Investigator
Davita Clinical Research
United States: Food and Drug Administration
TOPK103
NCT01170975
June 2010
April 2011
Name | Location |
---|---|
DaVita Clinical Researh | Minneapolis, Minnesota 55404 |