- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00499200
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy
July 7, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uppsala, Sweden, 753 23
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SRA-444 + Placebo
Experimental; Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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after each dose group completion
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To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET
Time Frame: 1 month
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Trial Manager, For Sweden: MedInfoNord@wyeth.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
July 9, 2007
First Submitted That Met QC Criteria
July 10, 2007
First Posted (Estimate)
July 11, 2007
Study Record Updates
Last Update Posted (Estimate)
July 9, 2008
Last Update Submitted That Met QC Criteria
July 7, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3197A1-1104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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