Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

Wyeth

Status and phase

Completed

Phase 1

Conditions

Alzheimer Disease

Treatments

Drug: SAM-531

Study type

Interventional

Funder types

Industry

Identifiers

NCT00479349

3193A1-1104

Details and patient eligibility

About

To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy Japanese young male and elderly subjects.

Enrollment

32 estimated patients

Sex

Male

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Men aged 20 to 45 years, inclusive, at screening.
Elderly men or women aged 65 years and above as of screening.
Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

Exclusion critereia

Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening.
Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.