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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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This is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to study the absorption, distribution, metabolism and elimination of PF-00299804.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single 45 mg oral dose of [14C]PF-00299804 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]PF00299804 | Drug | Single 45 mg oral dose of radiolabelled PF-00299804 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: Estimation of PK parameters (Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F and Vd/F, as data permit) for PF 00299804, major metabolites (if possible), and total radioactivity. | 1 month | |
| Mass balance: Calculation of % total recovery of total radioactivity in urine and feces; calculation of % dose excreted of major metabolites (if possible). | 1 month | |
| Metabolic profiling / metabolite identification: Metabolic profile of PF 00299804 derived from plasma, urine and fecal samples; identification of major metabolites of PF-00299804 in plasma, urine and/or feces if possible. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety laboratory tests, physical examination, vital signs, ECGs, concomitant medications and adverse event monitoring. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Tacoma | Washington | 98418 | 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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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |