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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: |
NCT00366483 |
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Date of registration:
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17/08/2006 |
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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 of Lecozotan SR in Healthy Young and Elderly Subjects
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Lecozotan SR Administered Orally to Healthy Young and Elderly Subjects |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00366483 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel 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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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For France, infomedfrance@wyeth.com |
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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: -Young subjects: Men aged 18 to 45 years. -Elderly subjects: Men and
women = 65 years of age. -Body mass index in the range of 18 to 30 kg/m2 and body weight =
50 kg. -Healthy as determined by the investigator.
Exclusion Criteria: -History of any neuropsychiatric disorder. -History of drug or alcohol
abuse.
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: Lecozotan SR
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Primary Outcome(s)
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The incidence of adverse events and adverse reactions will be calculated. The safety variables (vital signs, ECG parameters, and routine laboratory tests) and PK parameters will be measured throughout study period.
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Secondary Outcome(s)
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Pharmacokinetic analysis after single and multiple dosing
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Secondary ID(s)
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3098B1-130
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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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