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

Last updated on November 11, 2019

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Study Location
Pfizer Investigational Site
Long Beach, California, 90806 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Psychiatrically stable subjects with schizophrenia

- Evidence of stable schizophrenia symptomatology ≥ 3 months

- Score on MCCB Letter-number span + Spatial span subtest

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01518894
Pfizer
Completed
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia

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Descriptive Information
Brief Title  ICMJE A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
Official Title  ICMJE 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
Brief SummaryTo 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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)
  • Drug: Placebo
    Placebo oral solution Q24 hours for 14 days
Study Arms  ICMJE
  • Experimental: PF-04958242
    Interventions:
    • Drug: PF-04958242
    • Drug: PF-04958242
    • Drug: PF-04958242
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2012)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2012)
40
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion DateMarch 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01518894
Other Study ID Numbers  ICMJE B1701004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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