Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NSA-789 at 2 different doses
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Dose 1
Dose 2
Outcomes
Primary Outcome Measures
electroencephalogram
Secondary Outcome Measures
blood sample
Full Information
NCT ID
NCT00781794
First Posted
October 28, 2008
Last Updated
August 17, 2021
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00781794
Brief Title
Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Study Start Date
January 2009 (Anticipated)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dose 1
Arm Title
2
Arm Type
Experimental
Arm Description
Dose 2
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NSA-789 at 2 different doses
Primary Outcome Measure Information:
Title
electroencephalogram
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
blood sample
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
City
Rouffach
ZIP/Postal Code
68250
Country
France
City
Toul
ZIP/Postal Code
54201
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients
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