Overview

A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Subjects With Schizophrenia

Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in subjects with schizophrenia.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

1. Subjects with schizophrenia both male and female

2. Evidence of stable schizophrenia symptomatology for at least 3 months (no
hospitalizations for schizophrenia, no increase in level of psychiatric care due to
worsening of symptoms of schizophrenia, etc).

3. Subjects must be in ongoing maintenance antipsychotic therapy other than clozapine
(oral or depot) on a stable medication treatment regimen for for at least 2 months
prior to Day 1, including concomitant psychotropic medications.

Exclusion Criteria:

1. History of seizure

2. Pregnant or nursing females

3. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease
(including drug allergies, but excluding untreated, asymptomatic, seasonal allergies
at time of screening and at the time of dosing).