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The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental | [14C]PF-05221304 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]PF-05221304 | Drug | a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance | Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered | 0-96 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic profiling for PF-05221304 in plasma, urine, and feces | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces | 0-96 hr |
| Radioactivity AUClast |
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Inclusion Criteria:
Exclusion Criteria:
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity
| 0-96 hr |
| Plasma PF-05221304 AUClast | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304 | 0-96 hr |
| Radioactivity AUCinf | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for radioactivity | 0-96 hr |
| Plasma PF-05221304 AUCinf | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 | 0-96 hr |
| Radioactivity Cmax | Maximum Observed Plasma Concentration (Cmax) for radioactivity | 0-96 hr |
| Plasma PF-05221304 Cmax | Maximum Observed Plasma Concentration (Cmax) for PF-05221304 | 0-96 hr |
| Radioactivity Tmax | Time to Reach Maximum Observed Plasma Concentration for radioactivity | 0-96 hr |
| Plasma PF-05221304 Tmax | Time to Reach Maximum Observed Plasma Concentration for PF-05221304 | 0-96 hr |
| Radioactivity t1/2 | Plasma Decay Half-Life (t1/2) for radioactivity | 0-96 hr |
| Plasma PF-05221304 t1/2 | Plasma Decay Half-Life (t1/2) for PF-05221304 | 0-96 hr |
| Number of subjects experiencing an adverse event | Assessment by physical examinations, adverse event monitoring, clinical laboratory measurements, vital signs and ECG. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity. Treatment-emergent are events between dosing with study drug and up to 28 days after that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category. | Up to 28 days post dosing of IP on Day 1 |