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To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with schizophrenia or schizo-affective disorder who are currently clinically stable and to evaluate the serum and urine pharmacokinetics of PF-02545920 and the N-desmethyl metabolite, PF-01001252, after multiple doses of PF-02545920 administered orally.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-02545920 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: physical and neurological examination, adverse event reports, clinical laboratory tests, vital signs, and 12-lead ECGs throughout the conduct of the study. | ||
| Pharmacokinetic endpoints: Primary: AUCtau, Tmax and Cmax of PF-02545920 and PF-01001252 on Days 1 and 13. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoints include: PANSS, CGI-S, CGI-I, CDSS, CNSVS VS-M cognitive battery, ESRS-A and SSS change from baseline to day 12. | ||
| Secondary PK endpoints include AUClast, t1/2, Cavg, Cmax/Cmin ratio on Day 13, and urinary excretion parameters (renal clearance and amount excreted over the dosing interval) of PF-02545920 and PF-01001252 as data permit. |
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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 | George | South Africa |
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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 |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C545121 | 2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline |
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