A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product

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

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-01-31

Brief Summary

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This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.

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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 capsule: phase 1 and 2 studies

Intervention Type DRUG

125 mg dose of palbociclib. Formulation used in phase 1 and 2 studies

Palbociclib capsule: phase 3 studies

Intervention Type DRUG

125 mg dose of palbociclib. Formulation used in phase 3 studies

Palbociclib capsule: ICH

Intervention Type DRUG

125 mg dose of palbociclib. Intended final market formulation

Interventions

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palbociclib capsule: phase 1 and 2 studies

125 mg dose of palbociclib. Formulation used in phase 1 and 2 studies

Intervention Type DRUG

Palbociclib capsule: phase 3 studies

125 mg dose of palbociclib. Formulation used in phase 3 studies

Intervention Type DRUG

Palbociclib capsule: ICH

125 mg dose of palbociclib. Intended final market formulation

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