A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] PD-0332991 In Healthy Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/30/2013 |
| Start Date: | February 2013 |
| End Date: | April 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
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.
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).
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