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

Wyeth is now a wholly owned subsidiary of Pfizer40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer Disease

Interventions

Lecozotan SRDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Paris, France

Outcomes

Primary Outcomes

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 Outcomes

Pharmacokinetic analysis after single and multiple dosing

Data from ClinicalTrials.gov

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