Completed

A Phase 1, Single Dose, Fixed Sequence, 2-Period Cross-Over Absolute Oral Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of PD-0332991

What is being tested

Oral Drug Formulation of PD-0332991

+ Intravenous Formulation of PD-0332991

Drug

Who is being recruted

From 18 to 55 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Phase 1

Interventional

Study Start: May 2013

See protocol details

Summary

Principal SponsorPfizer

Last updated: December 17, 2013

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01802476

Principal SponsorPfizer

Last updated: December 17, 2013

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate

A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs)

Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age

3 exclusion criteria prevent from participating

A positive urine drug screen

Any condition which could possibly affect drug absorption

Pregnancy or actively nursing females, or females of childbearing potential

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Pfizer Investigational Site

Nottingham, United KingdomOpen Pfizer Investigational Site in Google Maps

CompletedOne Study Center