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Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00366483
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : March 16, 2007
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Lecozotan SR Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetic analysis after single and multiple dosing

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366483


Locations
France
Paris, France
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
More Information

ClinicalTrials.gov Identifier: NCT00366483     History of Changes
Other Study ID Numbers: 3098B1-130
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: March 16, 2007
Last Verified: March 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy young volunteers
healthy elderly volunteers
Alzheimer's disease
5HT1A antagonist
Health
Pharmacokinetics

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders