Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
NCT ID: NCT02097329
Last Updated: 2014-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2014-04-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1: Palbociclib under fed conditions
palbociclib commercial free base
125 mg oral capsule single dose
famotidine
20 mg oral tablet 10 hours before and 2 hours after palbociclib
rabeprazole
2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib
Cohort 2: Palbociclib under fed conditions
palbociclib commercial free base
125 mg oral capsule single dose
antacid
30 mL orally once (2h before palbociclib)
antacid
30 mL orally once (2h after palbociclib)
Interventions
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palbociclib commercial free base
125 mg oral capsule single dose
famotidine
20 mg oral tablet 10 hours before and 2 hours after palbociclib
rabeprazole
2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib
palbociclib commercial free base
125 mg oral capsule single dose
antacid
30 mL orally once (2h before palbociclib)
antacid
30 mL orally once (2h after palbociclib)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Use of tobacco or nicotine containing products within 3 months of screening.
* A positive urine drug screen.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5481038
Identifier Type: -
Identifier Source: org_study_id
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