A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] PD-0332991 In Healthy Male Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01756768
First received: December 20, 2012
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Radiation: [14C]-PD-0332991 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] PD-0332991 In Healthy Male Volunteers |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991 [ Time Frame: 0-192 hrs ] [ Designated as safety issue: No ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991 [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Maximum Observed Plasma Concentration (Cmax) of PD-0332991 [ Time Frame: 1-24hrs ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991 [ Time Frame: 1-24hrs ] [ Designated as safety issue: No ]
- Plasma Decay Half-Life (t1/2) of PD-0332991 [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Apparent Oral Clearance (CL/F) of PD-0332991 [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Apparent Volume of Distribution (Vz/F) of PD-0332991 [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Cumulative radioactivity recovery in urine. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Cumulative radioactivity recovery in feces. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PF-05089326. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089326. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Maximum Observed Plasma Concentration (Cmax) of PF-05089326. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089326. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Plasma Decay Half-Life (t1/2) of PF-05089326. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of radioactivity in plasma. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of radioactivity in plasma. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Maximum Observed Concentration (Cmax) of radioactivity in plasma. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Concentration (Tmax) of radioactivity in plasma. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Plasma Decay Half-Life (t1/2) of radioactivity in plasma. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Apparent Oral Clearance (CL/F) of radioactivity in plasma. [ Time Frame: 0-192hrs ] [ Designated as safety issue: No ]
- Apparent Volume of Distribution (Vz/F) of radioactivity in plasma. [ Time Frame: 0-192 hrs ] [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | January 2013 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Radio-labeled Dose Arm |
Radiation: [14C]-PD-0332991
A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of [14C]-PD-0332991.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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).
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01756768 History of Changes |
| Other Study ID Numbers: | A5481011 |
| Study First Received: | December 20, 2012 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 1 Mass Balance study Radio-labeled dose PD-0332991 |
ClinicalTrials.gov processed this record on May 16, 2013