Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects
Phase 1
Completed
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00366483
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Pharmacokinetic analysis after single and multiple dosing