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| Name | Class |
|---|---|
| Yale University | OTHER |
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The primary purpose of this study is to assess central receptor occupancy of PF 03654746 at the H3 receptor after a single oral dose of PF 03654746.
Additional Study Purpose Details: To validate PET ligand which will be used to determine receptor occupancy and to determine receptor occupancy of PF-0367456
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | This arm will have no active treatment. |
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| Cohort 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positron Emission tomography | Other | Positron Emission tomography scans. Part 1of the study : 4 subjects will receive 2 scans a day for 1 day with PET ligand administered in tracer quantities. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall H3 Receptor Occupancy of PF 03654746. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Binding potential (BP) of [C-11]PF 04621053. | 48 hours | |
| Relationship between serum PF 03654746 concentration and H3 RO (IC50). | 48 hours | |
| H3 RO of PF 03654746 at regions of interest in man |
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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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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C569672 | N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| PET Scan with PF-03654746 | Drug | If none of the data from Cohort 2 is informative, then: 2) an additional 3 subjects will receive 2 Scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746. Doses will be determined based upon the outcome of the first intervention. |
|
| PET Scan with PF-03654746 | Drug | If none of the data from the previous interventions are informative, then: 3) an additional 3 patients will receive 2 scans on Day 1 and 1 scan on Day 2 following three different doses of PF-0365476. Doses will be determined based upon the outcomes of the previous interventions. |
|
| PET Scan with PF-03654746 | Drug | Part 2 of the study will have 3 possible interventions: 1) 3 subjects in Cohort 2 will receive 2 scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746 (0.5 mg, 1.5 mg, 4 mg). |
|
| 48 hours |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06520 | United States |