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Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia

NCT ID: NCT02332798

Last Updated: 2021-10-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-06

Study Completion Date

2015-04-15

Brief Summary

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This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in multiple ascending doses in subjects with stable schizophrenia.

Detailed Description

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This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 compared to placebo over 14 days twice a day dosing in multiple ascending doses in subjects with stable schizophrenia.

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

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-04958242 0.25 mg

All participants who received PF-04958242 0.25 milligram (mg) twice daily (BID) for 14 consecutive days with the last dose occurring in the morning on Day 14.

Group Type EXPERIMENTAL

PF-04958242

Intervention Type DRUG

Administered as specified in the treatment arm

PF-04958242 0.475 mg

All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.

Group Type EXPERIMENTAL

PF-04958242

Intervention Type DRUG

Administered as specified in the treatment arm

Matching Placebo

All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm

Interventions

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PF-04958242

Administered as specified in the treatment arm

Intervention Type DRUG

Placebo

Administered as specified in the treatment arm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Psychiatrically stable (≥3 months) male and female subjects with schizophrenia of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>55 kg (121 lbs).
* DSM-IV Diagnosis of Schizophrenia; on stable medication treatment regimen ≥2 months.

Exclusion Criteria

* Suicide attempt within 3 months prior to screening.
* History of or risk of seizures; head injury with long term abnormal resulting condition, abnormal EEG, clinically significant additional diseases or conditions, current medication with a significant risk of seizures, currently receiving antipsychotic medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Collaborative Neuroscience Network, LLC.

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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MAD

Identifier Type: OTHER

Identifier Source: secondary_id

B1701017

Identifier Type: -

Identifier Source: org_study_id