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

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

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: PF-04958242
* Drug: PF-04958242
* Drug: PF-04958242
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04958242<br> | Drug: PF-04958242<br>* PF-04958242 0.10 mg oral solution Q24 hours for 14 days<br>Drug: PF-04958242<br>* PF-04958242 0.20 mg oral solution Q24 hours for 14 days<br>Drug: PF-04958242<br>* PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo oral solution Q24 hours for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1 |  | Day 1 - Day 2 | 
| Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 |  | Day 4 | 
| Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 |  | 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 |  | Day 14 - Day 17 | 
| Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 |  | Day 14 - Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cogntion - CogState |  | Day 0, 1, 6, 13 | 
| Cognition - Matrics Consensus Cognition Battery |  | Day 0, 1, 6, 13 | 
| Drug Effect Questionnaire liking scale |  | Day, 1, 14 | 
| Cognitive training |  | Days 0 - 13 | 
| Columbia Suicide Severity Rating Scale |  | Day 0, 1, 7, 14, 17, 23 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-04958242, multiple dose, Safety, schizophrenia