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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06412562 3mg

PF-06412562 3mg BID

Group Type EXPERIMENTAL

PF-06412562 3mg BID

Intervention Type DRUG

PF-06412562

PF-06412562 9mg

PF-06412562 9mg BID

Group Type EXPERIMENTAL

PF-06412562 9mg BID

Intervention Type DRUG

PF-06412562

PF-06412562 45mg

PF-06412562 45mg BID

Group Type EXPERIMENTAL

PF-06412562 45mg BID

Intervention Type DRUG

PF-06412562

Placebo

Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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PF-06412562 3mg BID

PF-06412562

Intervention Type DRUG

PF-06412562 9mg BID

PF-06412562

Intervention Type DRUG

PF-06412562 45mg BID

PF-06412562

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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PF-06412562 3mg PF-06412562 9mg PF-06412562 45mg

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No