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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Healthy
Interventions
DRUG

Palbociclib Alone

In Period 1 of each Cohort, a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.

DRUG

Palbociclib + Rabeprazole

In Period 2 of each Cohort, subjects will receive daily 40 mg oral doses of the proton pump inhibitor rabeprazole on 7 consecutive days. Approximately 4 hours after the last rabeprazole dose a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.

Trial Locations (3)

33143

MRA Clinical Research - Phase 1, Miami

Miami Research Associates, LLC, South Miami

MRA Clinical Research, LLC, South Miami

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02311946 - A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib | Biotech Hunter | Biotech Hunter