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Completed

NCT Number: NCT01518894

A 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Long Beach, California, 90806, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-04958242

Drug

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

Placebo

Drug

Placebo oral solution Q24 hours for 14 days

Primary outcomes

  1. 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

  2. Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4

    Time frame: Day 4

  3. Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7

    Time frame: Day 7

  4. 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

  5. Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14

    Time frame: Day 14 - Day 15

Secondary outcomes

  1. Cogntion - CogState

    Time frame: Day 0, 1, 6, 13

  2. Cognition - Matrics Consensus Cognition Battery

    Time frame: Day 0, 1, 6, 13

  3. Drug Effect Questionnaire liking scale

    Time frame: Day, 1, 14

  4. Cognitive training

    Time frame: Days 0 - 13

  5. Columbia Suicide Severity Rating Scale

    Time frame: Day 0, 1, 7, 14, 17, 23

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 26, 2012
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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