Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315

Wyeth

Status and phase

Terminated

Phase 1

Conditions

Alzheimer Disease

Treatments

Drug: SAM-315

Study type

Interventional

Funder types

Industry

Identifiers

NCT00474552

3182A1-101

Details and patient eligibility

About

Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects.

Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Young healthy subjects:

Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on study day 1.
Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg.

Elderly Healthy subjects:

Men or women aged 65 years and above as of study day 1.
BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg.

Exclusion criteria

Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
History of any clinically important drug allergy.