Back to resultsStudy Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Lecozotan SR
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring healthy young volunteers, healthy elderly volunteers, Alzheimer's disease, 5HT1A antagonist, Health, Pharmacokinetics
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pharmacokinetic analysis after single and multiple dosing
Full Information
NCT ID
NCT00366483
First Posted
August 17, 2006
Last Updated
March 15, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00366483
Brief Title
Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
healthy young volunteers, healthy elderly volunteers, Alzheimer's disease, 5HT1A antagonist, Health, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lecozotan SR
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Pharmacokinetic analysis after single and multiple dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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 France, infomedfrance@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects
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