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This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-03463275 oral controlled release formulation in Japanese and Western male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose | Experimental |
| |
| Multiple dose | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03463275 | Drug | Oral single 20 mg dose as two 10mg controlled release tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events monitoring | Day 0 to Day 4 in each period of Cohort A, Day 0 to Day 10 in Cohort B | |
| Vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, suicidality assessment | Screening and Day 0 to Day 4 in each period of Cohort A, Screening and Day 0 to Day 10 in Cohort B | |
| Serum (after single dose): Cmax, AUClast, AUCtau (Calculated only in Cohort B) and as data permit Tmax, AUCinf, t1/2 | Day 1 to Day 4 in each period of Cohort A, Day 1 in Cohort B | |
| Serum (after multiple dose): Ctrough, Cmax*, AUCtau* and as data permit Tmax*, t1/2* and Rac* (accumulation ratio) * Calculated only after the last administration. | Day 2 to Day 10 in Cohort B |
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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 | Glendale | California | 91206 | 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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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C549926 | 1-methyl-1H-imidazole-4-carboxylic acid (3-chloro-4-fluoro-benzyl)-(3-methyl-3-aza-bicyclo(3.1.0) hex-6-ylmethyl)amide |
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| PF-03463275 |
| Drug |
Oral single 40 mg dose as four 10mg controlled release tablets |
|
| PF-03463275 | Drug | Oral single 60 mg dose as six 10mg controlled release tablets |
|
| Placebo | Drug | Oral single dose as matching placebo |
|
| PF-03463275 | Drug | Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days |
|
| Placebo | Drug | Oral multiple doses as matching placebo for 7 days |
|