Status:
COMPLETED
A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 experi...
Detailed Description
This will be a 6 cohort study investigating one experimental formulation of palbociclib in each of the six cohorts of 10 healthy subjects. Each cohort will receive two treatments in a fixed-sequence. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02311946
Start Date
January 1 2015
End Date
April 1 2015
Last Update
May 28 2015
Active Locations (3)
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1
MRA Clinical Research - Phase 1
Miami, Florida, United States, 33143
2
Miami Research Associates, LLC
South Miami, Florida, United States, 33143
3
MRA Clinical Research, LLC
South Miami, Florida, United States, 33143