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.

Study Overview

• Status: Withdrawn
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: NSA-789 at 2 different doses

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rouffach, France, 68250
  • Toul, France, 54201
• United States
  • California
    • Glendale, California, United States, 91206

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3	Drug: NSA-789 at 2 different doses
Experimental: 1; Dose 1	Drug: NSA-789 at 2 different doses
Experimental: 2; Dose 2	Drug: NSA-789 at 2 different doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
electroencephalogram	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
blood sample	8 weeks

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2009
• Primary Completion (Anticipated): August 1, 2009
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: October 28, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 29, 2008

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 3230A1-1005