A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia

Pfizer

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: PF-02545920; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01829048

A8241018

Details and patient eligibility

About

To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication.

Enrollment: 37 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Psychiatrically stable subjects with schizophrenia.
• Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
• Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.

Exclusion criteria

• History of seizures or of a condition with risk of seizures.
• Subjects who have had electroconvulsive therapy within the 6 months prior to randomization.
• Pregnant or nursing females, and females of child bearing potential.

Trial design

37 participants in 2 patient groups, including a placebo group

PF-02545920

Experimental group

Treatment:

Drug: PF-02545920

Drug: PF-02545920

Drug: PF-02545920

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo