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

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02418819

Run by

Pfizer

People needed

103

Starts

2015-04-01

Expected to finish

2016-10-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with schizophrenia both male and female
• 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).
• 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.

You may not qualify if…

• History of seizure
• Pregnant or nursing females
• 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).

Where it is running

• Arcadia MRI & Imaging Center — Arcadia, California, United States
• California Clinical Trials Medical Group — Glendale, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Maryland Psychiatric Research Center (MPRC) of the University of Maryland — Baltimore, Maryland, United States
• CBH Health, LLC — Gaithersburg, Maryland, United States
• Foers Long Term Care Pharmacy LLC — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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