Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C] PF-00868554 and to characterize the metabolic profile following single dose administration.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | [14C]-PF-00868554 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-PF-00868554 | Drug | solution, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The amount of radioactivity recovered in urine and feces, as a percent of the dose. | 7 weeks | |
| The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces. | 7 weeks | |
| Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces. | 7 weeks | |
| PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs. | 7 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Tacoma | Washington | 98415 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided