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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02311946

Run by

Pfizer

People needed

60

Starts

2015-01-01

Expected to finish

2015-04-01

Last updated by the study team

2015-05-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MRA Clinical Research - Phase 1 — Miami, Florida, United States
• Miami Research Associates, LLC — South Miami, Florida, United States
• MRA Clinical Research, LLC — South Miami, Florida, United States

Full record on ClinicalTrials.gov

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