A Phase 1, Open-Label Fixed-Sequence 2-Period Crossover Study Of Palbociclib (pd-0332991) In Healthy Volunteers To Estimate The Effect Of Antacid Treatment On The Bioavailability Of A 125 Mg Single Dose Of Six Experimental Formulations Of Palbociclib Relative To Palbociclib Administration Alone Under Fasted Conditions

NCT02311946 Phase 1 COMPLETED

This study will investigate whether concurrent administration of rabeprazole, an antacid known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as one of six experimental formulations.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	60
Start date	2015-01
Completion	2015-04

Conditions

• Healthy

Interventions

• Palbociclib Alone
• Palbociclib + Rabeprazole

Primary outcomes

• AUCinf — Pre-dose to 120 hours post-dose
  Area under the concentration-time curve from time zero to infinity.
• Cmax — Pre-dose to 120 hours post-dose
  Maximum observed plasma concentration

Countries

United States