Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib
NCT ID: NCT02131298
Last Updated: 2014-06-30
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
12 participants
INTERVENTIONAL
2014-05-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Fixed sequence
Fixed sequence study with treatment A of palbociclib alone, followed by treatment B (palbociclib with itraconazole)
Palbociclib Alone
A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection
Palbociclib plus itraconazole
Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection.
Interventions
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Palbociclib Alone
A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection
Palbociclib plus itraconazole
Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
* Any condition possibly affecting drug absorption.
* A positive urine drug screen or alcohol breath test.
* Pregnant female subjects; breast feeding female subjects, female subjects of childbearing potential, male subjects with partners currently pregnant, male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.
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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A5481016
Identifier Type: -
Identifier Source: org_study_id