Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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)

Outcome Time Frame:

24 days

Safety Issue:

No

Principal Investigator

Ed Cullen, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Keryx / AOI Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

Protocol 147

NCT ID:

NCT01224730

Start Date:

January 2012

Completion Date:

May 2012

Related Keywords:

• Cancer