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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004356-37 | EudraCT Number |
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This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohor 1 - 30 mg | Experimental | Cohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562. |
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| Cohort 2 ( adaptive dose, optional) | Experimental | Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1. |
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| Cohort 3 ( adaptive dose, optional) | Experimental | Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1 and Cohort 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30 mg PF-06412562 | Drug | Subject will receive a single dose of 30 mg PF-06412562 |
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| Measure | Description | Time Frame |
|---|---|---|
| PF-06142562 plasma exposure and RO in the striatum | Using Positron Emission Tomography and a radiotracer [11C]SCH23390, the PF-06142562 plasma exposure and RO in the striatum (average of caudate and putamen) will be measured in healthy male subjects. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Day 1 | |
| Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4) |
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Inclusion Criteria:
Healthy Male Volunteers
Exclusion Criteria:
Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease Any condition possibly affecting drug absorption A positive urine drug screen
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Trial Alliance (KTA) M62 | Huddinge | Stockholm County | SE- 141 86 | Sweden |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-06412562 |
| Drug |
The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional. |
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| PF-06412562 | Drug | The dose will be selected based on the results obtained for Cohort 1 and Cohort 2. This Cohort is optional. |
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| Day 1 |
| Average plasma concentration over 4 hours (Cav,0-4) | Day 1 |