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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Schizophrenia

Schizo-affective Disorder

Treatments

Drug: PF-02545920

Study type

Interventional

Funder types

Industry

Identifiers

NCT00463372

A8241002

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

No 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).