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NCT01518894 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01518894
Other study ID # B1701004
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 2011
Est. completion date March 2012

Study information
Verified date November 2019
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PF-04958242
PF-04958242 0.10 mg oral solution Q24 hours for 14 days
• PF-04958242
PF-04958242 0.20 mg oral solution Q24 hours for 14 days
• PF-04958242
PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)
• Placebo
Placebo oral solution Q24 hours for 14 days

Locations
Country Name City State
United States Pfizer Investigational Site Long Beach California

Sponsors (1)
Lead Sponsor Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4 Day 4
Primary Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7 Day 7
Primary 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
Primary Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14 Day 14 - Day 15
Secondary Cogntion - CogState Day 0, 1, 6, 13
Secondary Cognition - Matrics Consensus Cognition Battery Day 0, 1, 6, 13
Secondary Drug Effect Questionnaire liking scale Day, 1, 14
Secondary Cognitive training Days 0 - 13
Secondary Columbia Suicide Severity Rating Scale Day 0, 1, 7, 14, 17, 23
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