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This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Optional Cohort 4 | Experimental |
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| Optional Cohort 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 mg PF-06412562 | Drug | oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS. | 0-15 days | |
| Pharmacokinetics: Cmax, Tmax, AUCÏ„ Ctrough, PTR, Rac on Cmax and AUCÏ„ t1/2, CL/F, PTR, | 0-15 days | |
| CogState at followup | 22-25 days |
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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 | New Haven | Connecticut | 06511 | 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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| 10 mg PF-06412562 |
| Drug |
oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days |
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| 25 mg PF-06412562 | Drug | oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days |
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| PF-06412562 TBD mg | Drug | oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts |
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| PF-06412562 TBD mg | Drug | oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts |
|