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Sponsors and Collaborators: |
Pfizer Taisho Pharmaceuticals |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00876304 |
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: PF-04802540 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | Phase 1, Investigator And Subject-Blind, Placebo-Controlled, Randomized, Sequential Group, Multiple Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04802540 In Patients With Schizophrenia |
Estimated Enrollment: | 40 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PF-04802540: Experimental |
Drug: PF-04802540
Multiple ascending doses for 10 days; planned doses include capsules totaling 5 mg and 20 mg every 12 hours, with additional doses determined based on accumulating data
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Placebo: Placebo Comparator |
Drug: Placebo
Placebo capsules every 12 hours for 10 days
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | B0911004 |
Study First Received: | April 3, 2009 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00876304 History of Changes |
Health Authority: | United States: Food and Drug Administration |
PF-04802540 multiple dose safety study |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |