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Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia

A Phase I, Investigator And Subject-Blind (Sponsor Unblinded), Placebo-Controlled Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-02545920 After Multiple Oral Dose Administration In Subjects With Stable Schizophrenia

NCT00463372•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with DSM-IV diagnosis of schizophrenia or schizo-affective disorder for whom antipsychotic monotherapy is indicated.
•Subjects must be free from an acute exacerbation of psychosis for at least 3 months prior to screening.
•Current Clinical Global Impression (CGI) of Severity of Illness score ≤ 3.

Exclusion Criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
•Evidence or history of a primary DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder.
•Any condition possibly affecting drug absorption (e.g., gastrectomy).

Locations (1)

Pfizer Investigational Site

George, South Africa

Key Dates

Start Date

October 1, 2006

Completion Date

May 1, 2007

Last Updated

September 5, 2018

Enrollment

Estimated participants

Conditions

SchizophreniaSchizo-affective Disorder

Interventions

PF-02545920

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia

Inclusion Criteria

Exclusion Criteria

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