Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
NCT02097329
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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.
- 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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Descriptive Information | ||||
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Brief Title ICMJE | Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 27 | |||
Original Estimated Enrollment ICMJE | 28 | |||
Actual Study Completion Date ICMJE | June 2014 | |||
Actual Primary Completion Date | June 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02097329 | |||
Other Study ID Numbers ICMJE | A5481038 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |