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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01518894
First received: January 23, 2012
Last updated: May 5, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: PF-04958242
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  • Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 [ Time Frame: Day 14 - Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cogntion - CogState [ Time Frame: Day 0, 1, 6, 13 ] [ Designated as safety issue: No ]
  • Cognition - Matrics Consensus Cognition Battery [ Time Frame: Day 0, 1, 6, 13 ] [ Designated as safety issue: No ]
  • Drug Effect Questionnaire liking scale [ Time Frame: Day, 1, 14 ] [ Designated as safety issue: No ]
  • Cognitive training [ Time Frame: Days 0 - 13 ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale [ Time Frame: Day 0, 1, 7, 14, 17, 23 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Placebo Comparator: Placebo Drug: Placebo
Placebo oral solution Q24 hours for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518894

Locations
United States, California
Pfizer Investigational Site
Long Beach, California, United States, 90806
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01518894     History of Changes
Other Study ID Numbers: B1701004
Study First Received: January 23, 2012
Last Updated: May 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-04958242
multiple dose
Safety
schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014