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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01518894

Enrollment

Registered

2012-01-26

Start date

2011-11-30

Completion date

2012-03-31

Last updated

2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

PF-04958242, multiple dose, Safety, schizophrenia

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.

Interventions

DRUGPF-04958242

PF-04958242 0.10 mg oral solution Q24 hours for 14 days

DRUGPlacebo

Placebo oral solution Q24 hours for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14	Day 14 - Day 15
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

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026