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A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers

NCT ID: NCT01756768

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

Brief Summary

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This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of \[14C\]-PD-0332991. Subjects will be checked in to the research unit from approximately 12 hours prior to dosing and remain in house until greater than 90% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta on consecutive days. This study will investigate the extent of involvement of the renal and hepatic systems in the elimination of PD-0332991 and will seek to identify the compound's major metabolites.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase 1 Mass Balance study Radio-labeled dose PD-0332991

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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Radio-labeled Dose Arm

Group Type EXPERIMENTAL

[14C]-PD-0332991

Intervention Type RADIATION

A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of \[14C\]-PD-0332991.

Interventions

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[14C]-PD-0332991

A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of \[14C\]-PD-0332991.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* A Healthy Male Volunteer between 18 and 55 years of age inclusive
* A Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \>50kg
* A signed informed consent document

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular,hepatic,psychiatric, neurologic, or allergic disease.
* A positive urine drug or urine cotinine screen.
* Concurrent use of herbal or prescription medications or treatment with an investigational drug within 30 days or 5 half-lives preceding first dose of study medication.
* Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
* Subjects with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome (IBS) or lactose intolerance).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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

Tacoma, Washington, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5481011&StudyName=A%20Single-Radiolabeled%20Dose%20Mass%20Balance%20Study%20To%20Investigate%20The%20Absorption%2C%20Metabolism%2C%20And%20Excretion%20Of%20%5B14C%5D%20Palbociclib%20%28PD-0332

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Other Identifiers

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A5481011

Identifier Type: -

Identifier Source: org_study_id