Back to resultsMultiple Dose Study Evaluating the Safety and Tolerability of NSA-789
Primary Purpose
Alzheimer Disease, Healthy Subjects
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NSA-789
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, schizophrenia
Eligibility Criteria
Inclusion Criteria
- Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
- Women must be surgically sterile or postmenopausal
- Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.
Exclusion Criteria
- Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
- Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
NSA-789
Arm Description
Outcomes
Primary Outcome Measures
Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability
Secondary Outcome Measures
Pharmacokinetic and pharmcodynamic parameters
Full Information
NCT ID
NCT00795730
First Posted
November 20, 2008
Last Updated
August 17, 2021
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00795730
Brief Title
Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789
Official Title
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects and Subjects With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
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
This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Healthy Subjects
Keywords
Alzheimer's Disease, schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
NSA-789
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NSA-789
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pharmacokinetic and pharmcodynamic parameters
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease)
Women must be surgically sterile or postmenopausal
Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled.
Exclusion Criteria
Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study.
Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of the study.
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
12. IPD Sharing Statement
Learn more about this trial
Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789
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