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

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: PF-04958242; Drug: Placebo

• Registration Number: NCT01518894
• Lead Sponsor: Biogen

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-26
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-19
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04958242	PF-04958242	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4	Day 4
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 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

Name	Time	Method
Columbia Suicide Severity Rating Scale	Day 0, 1, 7, 14, 17, 23
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Long Beach, California, United States