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Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | PH-797804 |
|
| Cohort 2 | Experimental | PH-797804 |
|
| Cohotr 3 | Experimental | PH-797804 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 mg | Drug | 1 mg or placebo a material sparing tablet per day for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities. | Day 1 to Follow-up | |
| Mean change from baseline in vital signs (blood pressure and heart rate) measurements | Baseline to Follow-up | |
| Mean change from baseline in 12-lead ECG parameters | Baseline to Follow-up | |
| Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax | Days 1 and 10 |
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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 | Culver City | California | 90232 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 5 mg |
| Drug |
5 mg or placebo as material sparing tablet per day for 10 days |
|
| 10 mg | Drug | 10 mg or placebo as a material sparing tablet per day for 10 days |
|
| Glendale |
| California |
| 91206 |
| United States |