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

November 19, 2019 updated by: Biogen

A Randomized, Double-Blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo oral solution Q24 hours for 14 days
Experimental: PF-04958242
Drug: PF-04958242
PF-04958242 0.10 mg oral solution Q24 hours for 14 days
Drug: PF-04958242
PF-04958242 0.20 mg oral solution Q24 hours for 14 days
Drug: PF-04958242
PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
Time Frame: Day 4
Day 4
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
Time Frame: Day 7
Day 7
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
Time Frame: Day 1 - Day 2
Day 1 - Day 2
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
Time Frame: Day 14 - Day 17
Day 14 - Day 17
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
Time Frame: Day 14 - Day 15
Day 14 - Day 15

Secondary Outcome Measures

Outcome Measure
Time Frame
Cogntion - CogState
Time Frame: Day 0, 1, 6, 13
Day 0, 1, 6, 13
Cognition - Matrics Consensus Cognition Battery
Time Frame: Day 0, 1, 6, 13
Day 0, 1, 6, 13
Drug Effect Questionnaire liking scale
Time Frame: Day, 1, 14
Day, 1, 14
Cognitive training
Time Frame: Days 0 - 13
Days 0 - 13
Columbia Suicide Severity Rating Scale
Time Frame: Day 0, 1, 7, 14, 17, 23
Day 0, 1, 7, 14, 17, 23

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 23, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1701004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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