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

NCT ID: NCT01518894

Last Updated: 2019-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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

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-04958242

Group Type EXPERIMENTAL

PF-04958242

Intervention Type DRUG

PF-04958242 0.10 mg oral solution Q24 hours for 14 days

PF-04958242

Intervention Type DRUG

PF-04958242 0.20 mg oral solution Q24 hours for 14 days

PF-04958242

Intervention Type DRUG

PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral solution Q24 hours for 14 days

Interventions

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PF-04958242

PF-04958242 0.10 mg oral solution Q24 hours for 14 days

Intervention Type DRUG

PF-04958242

PF-04958242 0.20 mg oral solution Q24 hours for 14 days

Intervention Type DRUG

PF-04958242

PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)

Intervention Type DRUG

Placebo

Placebo oral solution Q24 hours for 14 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Pfizer Investigational Site

Long Beach, California, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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B1701004

Identifier Type: -

Identifier Source: org_study_id

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