A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters
To assess the Pharmacokinetic profile of perifosine when given to patients under fed and fasted conditions To evaluate changes in other ECG parameters associated with perifosine treatment (ventricular rate, PR interval, QRS interval, QT interval)
Ed Cullen, PhD
Keryx / AOI Pharmaceuticals, Inc.
United States: Food and Drug Administration
|Austin, Texas 78705|