A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
NCT ID: NCT01844323
Last Updated: 2013-08-28
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
24 participants
INTERVENTIONAL
2013-06-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A
treatment A, reference, 20 micron palbociclib and lubrication level 1
Palbociclib Formulation Reference
Single 45 mg dose; Dosage form is capsule taken orally.
Treatment B
treatment B, test, 50 micron palbociclib and lubrication level 1
Palbociclib Formulation Test
Single 45 mg dose; Dosage form is capsule taken orally.
Treatment C
treatment C, test, 20 micron palbociclib and lubrication level 2
Palbociclib Formulation Test
Single 45 mg dose; Dosage form is capsule taken orally.
Treatment D
treatment D, test, 20 micron palbociclib and lubrication level 3
Palbociclib Formulation Test
Single 45 mg dose; Dosage form is capsule taken orally.
Interventions
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Palbociclib Formulation Reference
Single 45 mg dose; Dosage form is capsule taken orally.
Palbociclib Formulation Test
Single 45 mg dose; Dosage form is capsule taken orally.
Palbociclib Formulation Test
Single 45 mg dose; Dosage form is capsule taken orally.
Palbociclib Formulation Test
Single 45 mg dose; Dosage form is capsule taken orally.
Eligibility Criteria
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Inclusion Criteria
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) 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 (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) preceding the first dose of study medication.
* Pregnant females; breastfeeding females; females with physical possibility of getting pregnant .
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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A5481022
Identifier Type: -
Identifier Source: org_study_id