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



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:2/6/2019
Start Date:April 2015
End Date:October 2016

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A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, SPONSOR OPEN, PHASE 1B STUDY TO EXAMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-06412562 IN PSYCHIATRICALLY STABLE SUBJECTS WITH SCHIZOPHRENIA

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.

B7441007 is a randomized, double-blind, placebo-controlled, sponsor open, parallel group
design, Phase 1b study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of
3 doses of PF-06412562 (3 mg BID, 9 mg BID and 45 mg BID) over 15 days in approximately 100
psychiatrically stable (as defined by the inclusion and exclusion criteria) subjects with
schizophrenia are on background treatment with SOC antipsychotics and other psychotropic
medications.

All doses will be administered twice daily, with approximately 12 hours between each dose.

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).
We found this trial at
6
sites
Arcadia, California 91007
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Baltimore, MD
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Gaithersburg, Maryland 20877
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Gaithersburg, MD
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Glendale, California 91206
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Glendale, CA
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Glendale, California 91206
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Glendale, CA
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Rockville, Maryland 20850
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Rockville, MD
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