A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia

Biogen

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: PF-04958242

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518894

B1701004

Details and patient eligibility

About

To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242 administered orally to psychiatrically stable subjects with schizophrenia receiving antipsychotic and adjunctive medication.

Full description

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Enrollment: 30 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 ≥ 3 months
• Score on MCCB Letter-number span + Spatial span subtest < 40.

Exclusion criteria

• History of seizures or of a condition with risk of seizures
• History of abnormal EEG.
• Pregnant or nursing females, and women of child bearing potential

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

PF-04958242

Experimental group

Treatment:

Drug: PF-04958242

Drug: PF-04958242

Drug: PF-04958242

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo