A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Antacids; Palbociclib; Proton Pump Inhibitors; Rabeprazole

Criteria

Inclusion Criteria:

• Healthy Male or Female of non-childbearing potential,

• Having a body weight >50 kg

• Having a bopy mass index (BMI) between 17.5 and 30.5 kg/m2.

Exclusion Criteria:

• Any condition possibly affecting drug absorption (eg, gastrectomy)

• A positive urine drug or cotinine test

• A known history of hypersensitivity to palbociclib

• A supine systolic blood pressure >140 mmHg, or a QTc >450 msec.