Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy

Wyeth

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: SRA-444

Study type: Interventional

Funder types: Industry

Identifiers

NCT00499200

3197A1-1104

Details and patient eligibility

About

The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.

Enrollment: 42 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men or women from 60 years of age at screening.
• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion criteria

• History of drug abuse within 1 year before study day 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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42 participants in 1 patient group

SRA-444 + Placebo

Experimental group

Description:

Experimental; Placebo

Treatment:

Drug: SRA-444