Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy
NCT00499200
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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).
- History of drug abuse within 1 year before study day 1.
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Descriptive Information | |||||||
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Brief Title ICMJE | Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE | Alzheimer's Disease | ||||||
Intervention ICMJE | Drug: SRA-444 | ||||||
Study Arms ICMJE | Experimental: SRA-444 + Placebo
Experimental; Placebo Intervention: Drug: SRA-444 | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 42 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Actual Study Completion Date ICMJE | June 2008 | ||||||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Sweden | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00499200 | ||||||
Other Study ID Numbers ICMJE | 3197A1-1104 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Verification Date | July 2008 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |