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| Name | Class |
|---|---|
| Yale University | OTHER |
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The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-05212365 in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05212365 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05212365 | Drug | Single dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exposure response of 5-HT6 Receptor Occupancy (RO) of PF-05212365 in the striatum of healthy adult subjects | up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | continuous, up to 4 days | |
| Change from baseline in orthostatic blood pressure | Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose |
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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 | ||
| 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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| Change from baseline in supine blood pressure | Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose |
| Change from baseline in Singlet ECG | Baseline and 72 hrs post-dose |
| Clinically relevant levels of standard hemotology (e.g. Hemoglobin, Hematocrit RBC count), chemistry (e.g. BUN, Creatinine, fasting Glucose), and urinalysis (e.g. pH Glucose, Protein). | Baseline and 72 hrs post-dose |
| Abnormal findings from standard physical examination | Baseline and 72 hrs post-dose |
| Maximum concentration (Cmax) for PF-05212365 in plasma | up to 4 days |
| Time at Cmax (Tmax) for PF-05212365 in plasma | up to 4 days |
| Area under the concentration-time profile from time zero to the time of the last quantifiableconcentration (AUClast) for PF-05212365 in plasma | up to 4 days |
| Average concentration during the first post-dose PET scan (Cavg (scan 1)) for PF-05212365 in plasma | 2-4 hrs post-dose |
| Average concentration during the second post-dose PET scan (Cavg (scan 2)) for PF-05212365 in plasma | 48-50 hrs post dose |
| Change from baseline in orthostatic pulse rate | Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose |
| Change from baseline in supine pulse rate | Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose |
| Abnormal findings from standard neurological examination | Baseline and 72 hrs post-dose |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06520 | United States |
| ID | Term |
|---|---|
| C581984 | SAM-531 |
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