Study Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00892021
Collaborator
(none)
0
1
2
5
0
Study Details
Study Description
Brief Summary
This study will evaluate the safety of multiple doses of NSA-789 in subjects with schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is absorbed and eliminated, and its effect, if any, on the brain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Other
Official Title:
An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Subjects With Schizophrenia or Schizoaffective Disorder
Study Start Date
:
May 1, 2009
Anticipated Primary Completion Date
:
Oct 1, 2009
Anticipated Study Completion Date
:
Oct 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NSA-789 Active study drug |
Drug: NSA-789
|
| Placebo Comparator: Placebo Inactive study drug |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results) [6 months]
Secondary Outcome Measures
- Tolerability as measured through the reporting of adverse events; Pharmacokinetic as measured by the concentrations of NSA-789 in blood; Pharmacodynamics as measured by the results of psychiatric ratings and neurologic evaluations. [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion:
-
Men or women of non childbearing potential (WONCBP) aged 18 to 50 years, inclusive.
-
Currently under the care of a physician for psychiatric illness.
-
Clinical diagnosis of schizophrenia or schizo affective disorder in the opinion of the study psychiatrist based on review of all available clinical data.
Exclusion:
- Any unstable medical or psychiatric condition, which may prevent the successful and safe completion of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rockville | Maryland | United States | 20850 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00892021
Other Study ID Numbers:
- 3230A1-1003
First Posted:
May 4, 2009
Last Update Posted:
Aug 20, 2021
Last Verified:
Jul 1, 2009