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

NCT ID: NCT00781794

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

1

Dose 1

Group Type: EXPERIMENTAL

NSA-789 at 2 different doses

Intervention Type: DRUG

2

Dose 2

Group Type: EXPERIMENTAL

NSA-789 at 2 different doses

Intervention Type: DRUG

3

Group Type: PLACEBO_COMPARATOR

NSA-789 at 2 different doses

Intervention Type: DRUG

Interventions

NSA-789 at 2 different doses

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

Glendale, California, United States

Rouffach, , France

Toul, , France

Countries

United States; France

Other Identifiers

3230A1-1005

Identifier Type: -

Identifier Source: org_study_id