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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02332798
Pfizer
Completed
Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia

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Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia
A Randomized, Double-blind, Placebo Controlled, Sponsor Open, Parallel Group Phase 1b Study To Examine The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Doses Of Pf-04958242 In Subjects With Stable Schizophrenia
This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in multiple ascending doses in subjects with stable schizophrenia.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Schizophrenia
  • Drug: PF-04958242
    Oral capsule, 0.20 mg, twice a day dosing for 14 days
  • Drug: Placebo
    Oral capsule, placebo, twice a day dosing for 14 days
  • Drug: PF-04958242
    Oral capsule, 0.35 mg, twice a day dosing for 14 days
  • Experimental: Cohort 1- PF-04958242 or placebo
    Subjects receiving PF-04958242 or placebo for the treatment phase of the study
    Interventions:
    • Drug: PF-04958242
    • Drug: Placebo
  • Experimental: Cohort 2- PF-04958242 or placebo
    Subjects receiving PF-04958242 or placebo for the treatment phase of the study
    Interventions:
    • Drug: PF-04958242
    • Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
April 2015
April 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02332798
B1701017
MAD ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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