NCT01518894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

January 23, 2012

Last Update Submit

November 19, 2019

Conditions

Schizophrenia

Keywords

PF-04958242multiple doseSafetyschizophrenia

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

PF-04958242

EXPERIMENTAL
Drug: PF-04958242

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04958242DRUG

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

PF-04958242
PlaceboDRUG

Placebo oral solution Q24 hours for 14 days

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Psychiatrically stable subjects with schizophrenia
  • Evidence of stable schizophrenia symptomatology ≥ 3 months
  • Score on MCCB Letter-number span + Spatial span subtest \< 40.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Long Beach, California, 90806, United States

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

PF-04958242

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 26, 2012

Study Start

November 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

US(1)