A Phase 1, Open-Label, 3-Period Crossover Study Of The Effect Of An Antacid, A Proton Pump Inhibitor And An H2-Receptor Antagonist On Palbociclib (PD-0332991) Bioavailability Under Fed Conditions In Healthy Volunteers

NCT02097329 Phase 1 COMPLETED

To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	27
Start date	2014-04
Completion	2014-06

Conditions

• Healthy

Interventions

• palbociclib commercial free base
• famotidine
• rabeprazole
• palbociclib commercial free base
• antacid
• antacid

Primary outcomes

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] — 6 days
  AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
• Maximum Observed Plasma Concentration (Cmax) — 6 days

Countries

United States