Drug Interaction Study To Investigate The Potential Effect Of Proton Pump Inhibitor On The Pharmacokinetics Of Palbociclib (PD-0332991)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | December 2013 |
A Phase 1, Open-Label Fixed-Sequence 2-Period Crossover Study Of Palbociclib In Healthy Subjects To Investigate The Potential Effect Of Antacid Treatment On The Pharmacokinetics Of A Single Oral Dose Administered Under Fasted Conditions
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 gastric pH achieved by the treatment with multiple doses of
Rabeprazole might affect the absorption process of Palbociclib.
Palbociclib in absence and presence of prior administration of proton pump inhibitor
Rabeprazole. The increased gastric pH achieved by the treatment with multiple doses of
Rabeprazole might affect the absorption process of Palbociclib.
Inclusion Criteria:
- 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 Criteria:
- 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.
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