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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00480818 |
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Date of registration:
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29/05/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly Subjects
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Scientific title:
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An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Young and Elderly Subjects |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00480818 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion criteria :
- Men or women of nonchildbearing potential aged 18 to 45 years
- Elderly men or women aged 65 years and above as of study day 1.
- Body mass index in the range of 18 to 30 kg/m2 and body weight =50 kg. Body weight
for elderly subjects must be =45 kg.
Exclusion criteria:
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric
disease.
- Any clinically important deviation from normal limits in physical examination, vital
signs, digital 12-lead ECGs, or clinical laboratory test results.
- Tobacco use or the consumption of any caffeine-containing products (e.g., coffee,
tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1,
or grapefruit or grapefruit-containing products 72 hours before study day 1, and
until the end of the inpatient confinement period.
- Elderly men or women aged 65 years and above as of study day 1.
- Body mass index in the range of 18 to 30 kg/m2 and body weight =50 kg. Body weight
for elderly subjects must be =45 kg.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Intervention(s)
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Drug: SAM-531
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Primary Outcome(s)
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Safety and tolerability
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Secondary Outcome(s)
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Pharmacokinetics and pharmacodynamics
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Secondary ID(s)
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3193A1-102
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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