CompletedPhase 1

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

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

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Asset

Lecozotan

Listed sites

Recruiting sites

Enrollment

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥18

Primary endpoint

•Adverse events and adverse reactions

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID3098B1-130

NCT IDNCT00366483

Timeline

Milestones

Study start2006-05 (month precision)

Study first posted2006-08-21estimated

Last update posted2007-03-16estimated

Assets

Drug assets

Lecozotan

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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.

event count, event

Secondary/protocol endpoint

Pharmacokinetic analysis after single and multiple dosing

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.