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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

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Tacoma, Washington, 98418 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT01756768
Pfizer
Completed
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers

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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
A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] PD-0332991 In Healthy Male Volunteers
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Radiation: [14C]-PD-0332991
A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of [14C]-PD-0332991.
Experimental: Radio-labeled Dose Arm
Intervention: Radiation: [14C]-PD-0332991
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
March 2013
March 2013   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01756768
A5481011
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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