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Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Glendale, California, 91206 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

- Women of nonchildbearing potential, or men, aged 18 to 55 years inclusive on study day
1. Women of nonchildbearing potential may be included if they are either surgically
sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with a
follicle-stimulating hormone [FSH] level of ≥38 mIU/mL). Women who are surgically
sterile must provide documentation of the procedure by an operative report or
ultrasound scan. Sexually active men must agree to use a medically acceptable form of
contraception during the study and continue it for 12 weeks after test article
administration.

- Body mass index in the range of 18 to 32 kg/m2 and body weight ≥50 kg.

- Hemoglobin no lower than 0.4 g/dL, less than the lower limit of the normal range, and
white blood cell count no lower than 0.5 103/mm3, less than the lower limit of the of
the normal range at screening and day -1. Hematocrit and absolute neutrophil count
within normal range at screening and on day -1.

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

- Women of childbearing potential.

- Presence or history of any disorder that may prevent the successful completion of the
study.

- Any unstable psychiatric condition, which may prevent the successful and safe
completion of the study in the opinion of the investigator.

NCT00781794
Pfizer
Terminated
Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients

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Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients
A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of Single Oral Doses of NSA-789 on Auditory P50 Suppression in Nonsmoking Patients With Stabilized Schizophrenia
The purpose of this study is to evaluate the effect of single doses of NSA-789 on the P50 component of the auditory evoked potentials and to assess the safety, tolerability and the concentration of NSA-789 in the blood, in nonsmoking patients with schizophrenia.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Schizophrenia
Drug: NSA-789 at 2 different doses
  • Experimental: 1
    Dose 1
    Intervention: Drug: NSA-789 at 2 different doses
  • Experimental: 2
    Dose 2
    Intervention: Drug: NSA-789 at 2 different doses
  • Placebo Comparator: 3
    Intervention: Drug: NSA-789 at 2 different doses
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
August 2009
August 2009   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Women of nonchildbearing potential, or men, aged 18 to 55 years inclusive on study day 1. Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for â?¥1 year (with a follicle-stimulating hormone [FSH] level of â?¥38 mIU/mL). Women who are surgically sterile must provide documentation of the procedure by an operative report or ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
  • Body mass index in the range of 18 to 32 kg/m2 and body weight â?¥50 kg.
  • Hemoglobin no lower than 0.4 g/dL, less than the lower limit of the normal range, and white blood cell count no lower than 0.5 103/mm3, less than the lower limit of the of the normal range at screening and day -1. Hematocrit and absolute neutrophil count within normal range at screening and on day -1.

Exclusion criteria:

  • Women of childbearing potential.
  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any unstable psychiatric condition, which may prevent the successful and safe completion of the study in the opinion of the investigator.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   United States
 
 
NCT00781794
3230A1-1005
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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