Status:
COMPLETED
Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Fixed sequence, 2-period crossover study to compare the pharmacokinetic profiles of Palbociclib in absence and presence of prior administration of proton pump inhibitor Rabeprazole. The increased gast...
Eligibility Criteria
Inclusion
- Female subjects of non-childbearing potential; Healthy subjects identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory test.
Exclusion
- A positive urine drug screen, urine cotinine test or alcohol breath test.
- Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication. All antacid agents must be discontinued 28 days prior to the first dose of study medication.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01918176
Start Date
September 1 2013
End Date
December 1 2013
Last Update
October 8 2015
Active Locations (1)
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1
Pfizer Investigational Site
South Miami, Florida, United States, 33143