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A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)

NCT ID: NCT01802476

Last Updated: 2013-12-17

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of PD-0332991 administered as a 4-hour infusion.

Detailed Description

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Conditions

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Healthy

Keywords

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PD-0332991 Absolute Bioavailability Study

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fixed Sequence Crossover Arm

This study arm consists of a fixed sequence crossover where study subjects will receive Treatment A and following a washout of no less than 10 days will then receive Treatment B. The drug class is a CDK4/6 inhibitor.

Group Type OTHER

Oral Drug Formulation of PD-0332991

Intervention Type DRUG

Treatment A consists of a single 125 mg oral dose of PD-0332991.

Intravenous Formulation of PD-0332991

Intervention Type DRUG

Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate.

Interventions

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Oral Drug Formulation of PD-0332991

Treatment A consists of a single 125 mg oral dose of PD-0332991.

Intervention Type DRUG

Intravenous Formulation of PD-0332991

Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age.
2. A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs)

Exclusion Criteria

1. Any condition which could possibly affect drug absorption.
2. Pregnancy or actively nursing females, or females of childbearing potential.
3. A positive urine drug screen.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Nottingham, Nottinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5481015&StudyName=A%20Study%20Comparing%20the%20Plasma%20Drug%20Exposure%20of%20an%20Oral%20Dose%20of%20Palbociclib%20%28PD-0332991%29%20to%20an%20Intravenous%20Dose%20of%20Palbociclib%20%28PD

To obtain contact information for a study center near you, click here.

Other Identifiers

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QBR115052

Identifier Type: -

Identifier Source: secondary_id

A5481015

Identifier Type: -

Identifier Source: org_study_id