Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-03-31

Brief Summary

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A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Palbociclib given to healthy volunteers

Group Type EXPERIMENTAL

palbociclib isethionate (phase 1 and 2 studies)

Intervention Type DRUG

125 mg palbociclib isethionate salt under overnight fasting conditions

palbociclib isethionate (phase 1 and 2 studies)

Intervention Type DRUG

125 mg palbociclib isethionate salt under minimal fasting conditions (1 hr before palbociclib administration and 2 hrs post dose)

palbociclib commercial free base capsule

Intervention Type DRUG

125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal)

Interventions

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palbociclib isethionate (phase 1 and 2 studies)

125 mg palbociclib isethionate salt under overnight fasting conditions

Intervention Type DRUG

palbociclib isethionate (phase 1 and 2 studies)

125 mg palbociclib isethionate salt under minimal fasting conditions (1 hr before palbociclib administration and 2 hrs post dose)

Intervention Type DRUG

palbociclib commercial free base capsule

125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes