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This study was terminated on January 6, 2010, due to toxicology findings in animals exposed to PF-04455242 for three months.
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This is a subject blind, investigator and sponsor open, randomized study consisting of 2 parts. Up to 15 healthy subjects will be included in the study. In the first part of the study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor occupancy (RO) will be assessed in up to three cohorts of subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04455242 | Drug | Single dose of up to 30 mg PF-04455242, delivered in capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall kappa opioid receptor occupancy of PF 04455242. | Study Day 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Binding potential (BP) of [11C] PF 04767135. | Study Day 1 and 2 | |
| Kappa opioid receptor occupancy of PF 04455242 at regions of interest in man. | Study Day 1 and 2 | |
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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 | 06511-5473 | 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 |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| C568463 | 2-methyl-N-((2'-(pyrrolidin-1-ylsulfonyl)biphenyl-4-yl)methyl)propan-1-amine |
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| Relationship between plasma PF 04455242 concentration and kappa opioid receptor occupancy (IC50). |
| Study Day 1 and 2 |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06520 | United States |
| D001519 |
| Behavior |