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

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: August 17, 2006
Last updated: March 15, 2007
Last verified: March 2007

To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects.

Condition Intervention Phase
Alzheimer Disease
Drug: Lecozotan SR
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 40
Study Start Date: May 2006

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00366483

Paris, France
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For France,
  More Information

No publications provided Identifier: NCT00366483     History of Changes
Other Study ID Numbers: 3098B1-130
Study First Received: August 17, 2006
Last Updated: March 15, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on November 20, 2014