Back to resultsStudy Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
SRA-444
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion criteria:
- Men or women from 60 years of age at screening.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Exclusion criteria:
- History of drug abuse within 1 year before study day 1.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SRA-444 + Placebo
Arm Description
Experimental; Placebo
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease
To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET
Secondary Outcome Measures
Full Information
NCT ID
NCT00499200
First Posted
July 9, 2007
Last Updated
July 7, 2008
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00499200
Brief Title
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy
Official Title
A Positron Emission Tomography Study to Assess the Level and Duration of Occupancy of Serotonin-1A Receptors Produced by Single Oral Doses of SRA-444 in Healthy Elderly Subjects and in Subjects With Alzheimer Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
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 study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SRA-444 + Placebo
Arm Type
Experimental
Arm Description
Experimental; Placebo
Intervention Type
Drug
Intervention Name(s)
SRA-444
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease
Time Frame
after each dose group completion
Title
To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Men or women from 60 years of age at screening.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Exclusion criteria:
History of drug abuse within 1 year before study day 1.
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
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Sweden: MedInfoNord@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Uppsala
ZIP/Postal Code
753 23
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy
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