Back to resultsA Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04958242
PF-04958242
PF-04958242
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring PF-04958242, multiple dose, Safety, schizophrenia
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PF-04958242
Placebo
Arm Description
Outcomes
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
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
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
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
Secondary Outcome Measures
Cogntion - CogState
Cognition - Matrics Consensus Cognition Battery
Drug Effect Questionnaire liking scale
Cognitive training
Columbia Suicide Severity Rating Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01518894
Brief Title
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
PF-04958242, multiple dose, Safety, schizophrenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04958242
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04958242
Intervention Description
PF-04958242 0.10 mg oral solution Q24 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
PF-04958242
Intervention Description
PF-04958242 0.20 mg oral solution Q24 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
PF-04958242
Intervention Description
PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral solution Q24 hours for 14 days
Primary Outcome Measure Information:
Title
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
Title
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
Time Frame
Day 4
Title
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
Time Frame
Day 7
Title
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
Title
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
Time Frame
Day 14 - Day 15
Secondary Outcome Measure Information:
Title
Cogntion - CogState
Time Frame
Day 0, 1, 6, 13
Title
Cognition - Matrics Consensus Cognition Battery
Time Frame
Day 0, 1, 6, 13
Title
Drug Effect Questionnaire liking scale
Time Frame
Day, 1, 14
Title
Cognitive training
Time Frame
Days 0 - 13
Title
Columbia Suicide Severity Rating Scale
Time Frame
Day 0, 1, 7, 14, 17, 23
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1701004&StudyName=A%20Study%20To%20Examine%20The%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20Of%20%20PF-04958242%20In%20Psychiatrically%20Stable%20Subjects%20With%20Schizophrenia
Description
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A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
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