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
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 April 17, 2014