Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/5/2014 |
| Start Date: | April 2014 |
| End Date: | June 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 1, Open-Label, 3-Period Crossover Study Of The Effect Of An Antacid, A Proton Pump Inhibitor And An H2-Receptor Antagonist On Palbociclib (PD-0332991) Bioavailability Under Fed Conditions In Healthy Volunteers
To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist
and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential between the ages of
18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
lbs).
- Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, and other study procedures.
Exclusion Criteria:
- Evidence or history of clinically significant diseases (hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, or allergic disease).
- Use of tobacco or nicotine containing products within 3 months of screening.
- A positive urine drug screen.
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