Relative Bioavailability For Palbociclib Formulations

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-05-31

Brief Summary

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This study is to assess the relative bioavailability of palbociclib hard gelatin capsule formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single 125 mg oral doses under fed conditions in healthy volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A (Reference)

Group Type OTHER

Palbociclib Formulation Reference

Intervention Type DRUG

125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 1, which is representative of the intended commercial hard gelatin capsule.

Treatment B (Test)

Group Type OTHER

Palbociclib Formulation Test

Intervention Type DRUG

125 mg single dose of palbociclib formulation with 41 micrometer API particle size and dissolution level 1

Treatment C (Test)

Group Type OTHER

Palbociclib Formulation Test

Intervention Type DRUG

125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 2

Interventions

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Palbociclib Formulation Reference

125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 1, which is representative of the intended commercial hard gelatin capsule.

Intervention Type DRUG

Palbociclib Formulation Test

125 mg single dose of palbociclib formulation with 41 micrometer API particle size and dissolution level 1

Intervention Type DRUG

Palbociclib Formulation Test

125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects and/or female subjects with no physical possibility of getting pregnant.
* 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

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* 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 .

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes